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  1. Article: Carboplatin dosage formulae can generate inaccurate predictions of Carboplatin exposure in carboplatin/paclitaxel combination regimens.

    Nannan Panday, V R / van Warmerdam, L J / Huizing, M T / Ten Bokkel Huinink, W W / Vermorken, J B / Giaccone, G / Veenhof, C H / Schellens, J H / Beijnen, J H

    Clinical drug investigation

    2008  Volume 15, Issue 4, Page(s) 327–335

    Abstract: Carboplatin is a frequently used antitumour agent recommended to be administered according to the Calvert formula: dose = AUC x (GFR+25), where GFR is the glomerular filtration rate as measured by (51)Cr-EDTA clearance and AUC is the targeted area under ... ...

    Abstract Carboplatin is a frequently used antitumour agent recommended to be administered according to the Calvert formula: dose = AUC x (GFR+25), where GFR is the glomerular filtration rate as measured by (51)Cr-EDTA clearance and AUC is the targeted area under the carboplatin concentration versus time curve. In several modified Calvert formulae, the GFR is estimated on the basis of serum creatinine levels. We compared AUCs of carboplatin that were predicted by modified Calvert formulae with actual measured AUCs in 75 courses in patients with non-small cell lung cancer or ovarian cancer who were treated with the combination of carboplatin-paclitaxel. Predictions were made using two modified Calvert formulae, in which the GFR was calculated by serum creatinine level-based equations, according to Jelliffe (Eq. 1) and Cockroft-Gault (Eq. 2). We also studied the performance of a formula for the clearance of carboplatin, as proposed by Chatelut (Eq. 3). The actual measured mean AUC was 4.6 mg/ml.min (range 1.9 to 10.4 mg/ml.min, SD 1.7). Equation 1 overestimated the AUC by 32.9% with an imprecision of 43.0%, and equation 2 overestimated the AUC by 27.6% with an imprecision of 33.4%. For equation 3, an AUC overestimation of only 10.2%, but with an imprecision of 25.3%, was observed. In conclusion, all three equations overestimated the carboplatin AUCs and had poor precisions. We concluded that the real carboplatin AUCs were lower than calculated, using the three tested formulae. This may have important consequences for ongoing and future phase II and III studies with carboplatin-paclitaxel combinations, utilising these formulae to calculate the carboplatin dose. Thus far, the original Calvert dosage formula remains the 'golden standard'.
    Language English
    Publishing date 2008-03-28
    Publishing country New Zealand
    Document type Journal Article
    ZDB-ID 1220136-4
    ISSN 1179-1918 ; 1173-2563 ; 0114-2402
    ISSN (online) 1179-1918
    ISSN 1173-2563 ; 0114-2402
    DOI 10.2165/00044011-199815040-00009
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  2. Article: Cremophor EL causes (pseudo-) non-linear pharmacokinetics of paclitaxel in patients.

    van Tellingen, O / Huizing, M T / Panday, V R / Schellens, J H / Nooijen, W J / Beijnen, J H

    British journal of cancer

    1999  Volume 81, Issue 2, Page(s) 330–335

    Abstract: The non-linear plasma pharmacokinetics of paclitaxel in patients has been well established, however, the exact underlying mechanism remains to be elucidated. We have previously shown that the non-linear plasma pharmacokinetics of paclitaxel in mice ... ...

    Abstract The non-linear plasma pharmacokinetics of paclitaxel in patients has been well established, however, the exact underlying mechanism remains to be elucidated. We have previously shown that the non-linear plasma pharmacokinetics of paclitaxel in mice results from Cremophor EL. To investigate whether Cremophor EL also plays a role in the non-linear pharmacokinetics of paclitaxel in patients, we have established its pharmacokinetics in patients receiving paclitaxel by 3-, 24- or 96-h intravenous infusion. The pharmacokinetics of Cremophor EL itself was non-linear as the clearance (Cl) in the 3-h schedules was significantly lower than when using the longer 24- or 96-h infusions (Cl175-3 h = 42.8+/-24.9 ml h(-1) m(-2); CI175-24 h = 79.7+/-24.3; P = 0.035 and Cl135-3 h = 44.1+/-21.8 ml h(-1) m(-1); Cl140-96 h = 211.8+/-32.0; P < 0.001). Consequently, the maximum plasma levels were much higher (0.62%) in the 3-h infusions than when using longer infusion durations. By using an in vitro equilibrium assay and determination in plasma ultrafiltrate we have established that the fraction of unbound paclitaxel in plasma is inversely related with the Cremophor EL level. Despite its relatively low molecular weight, no Cremophor EL was found in the ultrafiltrate fraction. Our results strongly suggest that entrapment of paclitaxel in plasma by Cremophor EL, probably by inclusion in micelles, is the cause of the apparent nonlinear plasma pharmacokinetics of paclitaxel. This mechanism of a (pseudo-)non-linearity contrasts previous postulations about saturable distribution and elimination kinetics and means that we must re-evaluate previous assumptions on pharmacokinetics-pharmacodynamics relationships.
    MeSH term(s) Area Under Curve ; Dialysis ; Glycerol/analogs & derivatives ; Glycerol/blood ; Glycerol/pharmacology ; Humans ; Paclitaxel/administration & dosage ; Paclitaxel/blood ; Paclitaxel/pharmacokinetics ; Pharmaceutical Vehicles/pharmacology ; Surface-Active Agents/pharmacology
    Chemical Substances Pharmaceutical Vehicles ; Surface-Active Agents ; cremophor EL (6D4M1DAL6O) ; Paclitaxel (P88XT4IS4D) ; Glycerol (PDC6A3C0OX)
    Language English
    Publishing date 1999-09
    Publishing country England
    Document type Journal Article
    ZDB-ID 80075-2
    ISSN 1532-1827 ; 0007-0920
    ISSN (online) 1532-1827
    ISSN 0007-0920
    DOI 10.1038/sj.bjc.6690696
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  3. Article: A limited-sampling model for the pharmacokinetics of carboplatin administered in combination with paclitaxel.

    Nannan Panday, V R / van Warmerdam, L J / Huizing, M T / Ten Bokkel Huinink, W W / Schellens, J H / Beijnen, J H

    Journal of cancer research and clinical oncology

    1999  Volume 125, Issue 11, Page(s) 615–620

    Abstract: Purpose: Carboplatin doses are often determined by using modified Calvert formulas. It has been observed that the area under the concentration versus time curve (AUC) for free carboplatin is lower than expected when modified formulas are used for ... ...

    Abstract Purpose: Carboplatin doses are often determined by using modified Calvert formulas. It has been observed that the area under the concentration versus time curve (AUC) for free carboplatin is lower than expected when modified formulas are used for carboplatin/paclitaxel chemotherapy combination regimens. By using limited-sampling models, the carboplatin AUC actually reached can easily be verified, and the dose adjusted accordingly.
    Methods: In this report, we describe the development and validation of a limited-sampling model for carboplatin from 77 pharmacokinetic curves, when carboplatin is used in combination with paclitaxel.
    Results: The following single-point model was selected as optimal: AUC carboplatin (min mg(-1) ml(-1)) = 418. c(2.5 h)(mg/ml) + 0.43 (min mg(-1) ml(-1)), where c(2.5 h) is the concentration (mg/ml) of carboplatin 2.5 h after the start of a 30-min infusion. This model proved to be unbiased (mean prediction error = 3.4 +/- 1.6%) and precise (root mean square error = 10.1 +/- 1.5%).
    Conclusions: The proposed model can be very useful for ongoing and future carboplatin/paclitaxel studies aimed to optimise and individualize treatment.
    MeSH term(s) Aged ; Antineoplastic Combined Chemotherapy Protocols/pharmacokinetics ; Area Under Curve ; Carboplatin/pharmacokinetics ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Female ; Humans ; Lung Neoplasms/drug therapy ; Models, Biological ; Ovarian Neoplasms/drug therapy ; Paclitaxel/pharmacokinetics ; Time Factors
    Chemical Substances Carboplatin (BG3F62OND5) ; Paclitaxel (P88XT4IS4D)
    Language English
    Publishing date 1999-11
    Publishing country Germany
    Document type Journal Article
    ZDB-ID 134792-5
    ISSN 1432-1335 ; 0171-5216 ; 0084-5353 ; 0943-9382
    ISSN (online) 1432-1335
    ISSN 0171-5216 ; 0084-5353 ; 0943-9382
    DOI 10.1007/s004320050324
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  4. Article: Paclitaxel in the treatment of human immunodeficiency virus 1-associated Kaposi's sarcoma--drug-drug interactions with protease inhibitors and a nonnucleoside reverse transcriptase inhibitor: a case report study.

    Nannan Panday, V R / Hoetelmans, R M / van Heeswijk, R P / Meenhorst, P L / Inghels, M / Mulder, J W / Beijnen, J H

    Cancer chemotherapy and pharmacology

    1999  Volume 43, Issue 6, Page(s) 516–519

    Abstract: Purpose: To describe the pharmacokinetics of paclitaxel and to investigate the interaction potential with protease inhibitors (indinavir, ritonavir, saquinavir) and the nonnucleoside reverse transcriptase inhibitor nevirapine, for which strong ... ...

    Abstract Purpose: To describe the pharmacokinetics of paclitaxel and to investigate the interaction potential with protease inhibitors (indinavir, ritonavir, saquinavir) and the nonnucleoside reverse transcriptase inhibitor nevirapine, for which strong theoretical indications for clinically relevant drug interactions exist.
    Methods: The 24-h plasma pharmacokinetics of paclitaxel (Taxol, given at 100 mg/m2 by 3-h intravenous infusion) and concomitantly infused antiretroviral drugs were determined in a human immunodeficiency virus 1 (HIV-1)-infected male patient with refractory Kaposi's sarcoma (KS) during high-activity antiretroviral therapy and after discontinuation of this regimen. The plasma pharmacokinetics of paclitaxel, indinavir, ritonavir, saquinavir, and nevirapine were closely monitored. Since all these drugs are extensively metabolized via the cytochrome P450 enzyme system and are substrates for the multidrug transporter P-glycoprotein, investigation of drug-drug interactions was considered important.
    Results: In this case report study the pharmacokinetics of paclitaxel given concomitantly with various antiretroviral drugs were comparable with those of historical controls who had been treated with single-agent paclitaxel. The pharmacokinetics of indinavir, ritonavir, saquinavir, and nevirapine were also not statistically significantly different from those recorded for historical controls. Paclitaxel was well tolerated and resulted in a significant clinical response in this patient.
    Conclusion: Dose adjustments of paclitaxel, indinavir, ritonavir, saquinavir, or nevirapine are apparently not needed if HIV-1-associated KS is treated with paclitaxel at a dose of 100 mg/m2 as shown in the present case. It is stressed, however, that controlled studies are necessary to substantiate these preliminary case report findings.
    MeSH term(s) Acquired Immunodeficiency Syndrome/complications ; Acquired Immunodeficiency Syndrome/drug therapy ; Antineoplastic Agents, Phytogenic/pharmacokinetics ; Drug Interactions ; HIV Protease Inhibitors/pharmacokinetics ; HIV Protease Inhibitors/therapeutic use ; HIV-1 ; Humans ; Male ; Middle Aged ; Paclitaxel/pharmacokinetics ; Paclitaxel/therapeutic use ; Reverse Transcriptase Inhibitors/pharmacokinetics ; Reverse Transcriptase Inhibitors/therapeutic use ; Sarcoma, Kaposi/drug therapy
    Chemical Substances Antineoplastic Agents, Phytogenic ; HIV Protease Inhibitors ; Reverse Transcriptase Inhibitors ; Paclitaxel (P88XT4IS4D)
    Language English
    Publishing date 1999
    Publishing country Germany
    Document type Case Reports ; Journal Article
    ZDB-ID 6820-2
    ISSN 1432-0843 ; 0344-5704 ; 0943-9404
    ISSN (online) 1432-0843
    ISSN 0344-5704 ; 0943-9404
    DOI 10.1007/s002800050932
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  5. Article: A single 24-hour plasma sample does not predict the carboplatin AUC from carboplatin-paclitaxel combinations or from a high-dose carboplatin-thiotepa-cyclophosphamide regimen.

    Panday, V R / van Warmerdam, L J / Huizing, M T / Rodenhuis, S / Schellens, J H / Beijnen, J H

    Cancer chemotherapy and pharmacology

    1999  Volume 43, Issue 5, Page(s) 435–438

    Abstract: Purpose: It has been observed that the area under the free carboplatin concentration in plasma ultrafiltrate versus time curve (AUC) is related to toxicity and tumour response. For this reason, it can be important to measure the carboplatin AUC and ... ...

    Abstract Purpose: It has been observed that the area under the free carboplatin concentration in plasma ultrafiltrate versus time curve (AUC) is related to toxicity and tumour response. For this reason, it can be important to measure the carboplatin AUC and subsequently adjust the dose to achieve a predefined target AUC. The use of limited sampling strategies enables relatively simple measurement and calculation of actual carboplatin AUCs.
    Methods: We studied the performance of a limited sampling model, based on a single 24-h sample (the Ghazal-Aswad model). in 52 patients who received carboplatin in two different chemotherapy regimens (a carboplatin-paclitaxel combination and a high-dose carboplatin-thiotepa-cyclophosphamide combination).
    Results: The measured mean AUC in our population was 4.1 min x mg/ml (median 3.9, range 1.9 6.3, SD 1.0 min x mg/ml). With the limited sampling model, the predicted mean AUC was 4.4 min x mg/ml (median 4.2, range 2.4-8.4, SD 1.2 min x mg/ml). Statistical analysis revealed that the model was slightly biased (MPE%, 6.5%), but imprecise (RMSE%, 20.6%) in our study population.
    Conclusion: Although easy and attractive to use, the Ghazal-Aswad formula is not precise enough to predict the carboplatin AUC, and needs to be evaluated prospectively in other patient populations.
    MeSH term(s) Adolescent ; Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols/blood ; Antineoplastic Combined Chemotherapy Protocols/pharmacokinetics ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Area Under Curve ; Carboplatin/administration & dosage ; Carboplatin/blood ; Carboplatin/pharmacokinetics ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Non-Small-Cell Lung/metabolism ; Cyclophosphamide/blood ; Cyclophosphamide/pharmacokinetics ; Humans ; Lung Neoplasms/drug therapy ; Middle Aged ; Paclitaxel/administration & dosage ; Paclitaxel/blood ; Paclitaxel/pharmacokinetics ; Retrospective Studies ; Thiotepa/blood ; Thiotepa/pharmacokinetics
    Chemical Substances Cyclophosphamide (8N3DW7272P) ; Thiotepa (905Z5W3GKH) ; Carboplatin (BG3F62OND5) ; Paclitaxel (P88XT4IS4D)
    Language English
    Publishing date 1999-04-01
    Publishing country Germany
    Document type Clinical Trial ; Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article
    ZDB-ID 6820-2
    ISSN 1432-0843 ; 0344-5704 ; 0943-9404
    ISSN (online) 1432-0843
    ISSN 0344-5704 ; 0943-9404
    DOI 10.1007/s002800050919
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  6. Article: Hepatic metabolism of paclitaxel and its impact in patients with altered hepatic function.

    Panday, V R / Huizing, M T / Willemse, P H / De Graeff, A / ten Bokkel Huinink, W W / Vermorken, J B / Beijnen, J H

    Seminars in oncology

    1997  Volume 24, Issue 4 Suppl 11, Page(s) S11–34–S11–38

    Abstract: Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) has been demonstrated to be an active anticancer agent, including in platinum-refractory ovarian cancer. The pharmacokinetics of paclitaxel have been extensively described. It displays ... ...

    Abstract Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) has been demonstrated to be an active anticancer agent, including in platinum-refractory ovarian cancer. The pharmacokinetics of paclitaxel have been extensively described. It displays nonlinear pharmacokinetics in humans, especially when administered in shorter infusion times and at higher doses. Several relationships have been established between pharmacokinetics and pharmacodynamics. In both animal and human studies, hepatic metabolism and biliary excretion have been identified as the main elimination pathways of paclitaxel. It thus can be expected that hepatic dysfunction will have a major impact on the pharmacokinetics of paclitaxel and its main metabolite 6alpha-hydroxypaclitaxel and, thus, on pharmacodynamic outcome (toxicities and responses). Because patients with an altered hepatic function were excluded from most phase I and II studies conducted thus far, little is known about the pharmacokinetics and pharmacodynamics in this group of patients. This report summarizes paclitaxel's metabolism and clinical observations concerning its pharmacokinetics and pharmacodynamics in patients with altered hepatic function. It has been shown that hepatic impairment has a great influence on the systemic exposure of paclitaxel and metabolites with pharmacodynamic consequences. A decrease of biliary elimination is probably the major mechanistic effect that influences paclitaxel metabolism and elimination. Specific dosing guidelines in the treatment of patients with altered hepatic function are required.
    MeSH term(s) Animals ; Antineoplastic Agents, Phytogenic/pharmacokinetics ; Humans ; Liver/metabolism ; Liver Diseases/metabolism ; Paclitaxel/pharmacokinetics
    Chemical Substances Antineoplastic Agents, Phytogenic ; Paclitaxel (P88XT4IS4D)
    Language English
    Publishing date 1997-08
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 189220-4
    ISSN 1532-8708 ; 0093-7754
    ISSN (online) 1532-8708
    ISSN 0093-7754
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  7. Article: Primary leiomyosarcoma of the heart presenting as obstruction to the pulmonary trunk.

    Panday, V R / Cramer, M J / Elbers, H R / de la Riviere, A B / Ernst, S M / Plokker, H W

    American heart journal

    1997  Volume 133, Issue 4, Page(s) 465–466

    MeSH term(s) Aged ; Follow-Up Studies ; Heart Neoplasms/complications ; Heart Neoplasms/diagnosis ; Heart Neoplasms/surgery ; Heart Ventricles ; Humans ; Leiomyosarcoma/complications ; Leiomyosarcoma/diagnosis ; Leiomyosarcoma/surgery ; Male ; Pulmonary Valve Stenosis/etiology ; Time Factors ; Treatment Outcome
    Language English
    Publishing date 1997-04
    Publishing country United States
    Document type Case Reports ; Journal Article
    ZDB-ID 80026-0
    ISSN 1097-6744 ; 0002-8703
    ISSN (online) 1097-6744
    ISSN 0002-8703
    DOI 10.1016/s0002-8703(97)70191-1
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  8. Article: Pharmacologic study of paclitaxel administered with or without the cytoprotective agent amifostine, and given as a single agent or in combination with epirubicin and cisplatin in patients with advanced solid tumors.

    Van den Brande, J / Nannan Panday, V R / Hoekman, K / Rosing, H / Huijskes, R V / Verheijen, R H / Beijnen, J H / Vermorken, J B

    American journal of clinical oncology

    2001  Volume 24, Issue 4, Page(s) 401–403

    Abstract: The main purpose of this study was to investigate whether the coadministration of amifostine alters the pharmacokinetic behavior of paclitaxel. Eight patients were included in the study: six received paclitaxel in combination with epirubicin and ... ...

    Abstract The main purpose of this study was to investigate whether the coadministration of amifostine alters the pharmacokinetic behavior of paclitaxel. Eight patients were included in the study: six received paclitaxel in combination with epirubicin and cisplatin, and two received paclitaxel as a single agent. Doses of paclitaxel in these protocols were 135, 150, 175, and 200 mg/m(2) and two patients were treated at each dose level. Pharmacokinetic sampling for paclitaxel analysis was performed in each patient during two consecutive cycles, one with and one without amifostine (750 mg/m(2) as a 15-minute intravenous infusion 30 minutes before paclitaxel administration). At each dose level, the pharmacokinetic data of paclitaxel were compared per patient for a cycle without amifostine versus a cycle with amifostine. Amifostine did not seem to interact pharmacokinetically with paclitaxel, given either alone or in combination chemotherapy. This is in line with the clinical findings that amifostine has no negative effects on the antitumor activity of various antineoplastic agents. Also, amifostine may reduce toxic effects of combination chemotherapy regimens that include paclitaxel.
    MeSH term(s) Amifostine/pharmacology ; Amifostine/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Cisplatin/administration & dosage ; Drug Interactions ; Epirubicin/administration & dosage ; Female ; Humans ; Male ; Middle Aged ; Neoplasms/drug therapy ; Paclitaxel/administration & dosage ; Paclitaxel/pharmacokinetics ; Paclitaxel/therapeutic use ; Radiation-Protective Agents/pharmacology ; Radiation-Protective Agents/therapeutic use ; Radiation-Sensitizing Agents/administration & dosage ; Radiation-Sensitizing Agents/pharmacokinetics ; Radiation-Sensitizing Agents/therapeutic use
    Chemical Substances Radiation-Protective Agents ; Radiation-Sensitizing Agents ; Epirubicin (3Z8479ZZ5X) ; Amifostine (M487QF2F4V) ; Paclitaxel (P88XT4IS4D) ; Cisplatin (Q20Q21Q62J)
    Language English
    Publishing date 2001-04-09
    Publishing country United States
    Document type Journal Article
    ZDB-ID 604536-4
    ISSN 1537-453X ; 0277-3732
    ISSN (online) 1537-453X
    ISSN 0277-3732
    DOI 10.1097/00000421-200108000-00020
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  9. Article: Cremophor EL pharmacokinetics in a phase I study of paclitaxel (Taxol) and carboplatin in non-small cell lung cancer patients.

    Meerum Terwogt, J / van Tellingen, O / Nannan Panday, V R / Huizing, M T / Schellens, J H / ten Bokkel Huinink, W W / Boschma, M U / Giaccone, G / Veenhof, C H / Beijnen, J H

    Anti-cancer drugs

    2000  Volume 11, Issue 9, Page(s) 687–694

    Abstract: The purpose of our study was to investigate the pharmacokinetics of Cremophor EL following administration of escalating doses of Taxol (paclitaxel dissolved in Cremophor EL/ethanol) to non-small cell lung cancer (NSCLC) patients. Patients with NSCLC ... ...

    Abstract The purpose of our study was to investigate the pharmacokinetics of Cremophor EL following administration of escalating doses of Taxol (paclitaxel dissolved in Cremophor EL/ethanol) to non-small cell lung cancer (NSCLC) patients. Patients with NSCLC stage IIIb or IV without prior chemotherapy treatment were eligible for treatment with paclitaxel and carboplatin in a dose-finding phase I study. The starting dose of paclitaxel was 100 mg/m2 and doses were escalated with steps of 25 mg/m2, which is equal to a starting dose of Cremophor EL of 8.3 ml/m2 with dose increments of 2.1 ml/m2. Carboplatin dosages were 300, 350 or 400 mg/m2. Pharmacokinetic sampling was performed during the first and the second course, and the samples were analyzed using a validated high-performance liquid chromatographic assay. A total of 39 patients were included in this pharmacokinetic part of the study. The doses of paclitaxel were escalated up to 250 mg/m2 (20.8 ml/m2 Cremophor EL). Pharmacokinetic analyses revealed a low elimination-rate of Cremophor EL (CI=37.8-134 ml/h/m2; t 1/2=34.4-61.5 h) and a volume of distribution similar to the volume of the central blood compartment (Vss=4.96-7.85 l). In addition, a dose-independent clearance of Cremophor EL was found indicating linear kinetics. Dose adjustment using the body surface area, however, resulted in a non-linear increase in systemic exposure. The use of body surface area in calculations of Cremophor EL should therefore be re-evaluated.
    MeSH term(s) Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols/pharmacokinetics ; Area Under Curve ; Carboplatin/administration & dosage ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Non-Small-Cell Lung/metabolism ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Female ; Glycerol/administration & dosage ; Glycerol/analogs & derivatives ; Glycerol/pharmacokinetics ; Humans ; Lung Neoplasms/drug therapy ; Lung Neoplasms/metabolism ; Male ; Middle Aged ; Paclitaxel/administration & dosage ; Pharmaceutical Vehicles/administration & dosage ; Pharmaceutical Vehicles/pharmacokinetics
    Chemical Substances Pharmaceutical Vehicles ; cremophor EL (6D4M1DAL6O) ; Carboplatin (BG3F62OND5) ; Paclitaxel (P88XT4IS4D) ; Glycerol (PDC6A3C0OX)
    Language English
    Publishing date 2000-11-16
    Publishing country England
    Document type Clinical Trial ; Clinical Trial, Phase I ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
    ZDB-ID 1065301-6
    ISSN 1473-5741 ; 0959-4973
    ISSN (online) 1473-5741
    ISSN 0959-4973
    DOI 10.1097/00001813-200010000-00003
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  10. Article: Phase I and pharmacologic study of the combination of paclitaxel, cisplatin, and topotecan administered intravenously every 21 days as first-line therapy in patients with advanced ovarian cancer.

    Herben, V M / Panday, V R / Richel, D J / Schellens, J H / van der Vange, N / Rosing, H / Beusenberg, F D / Hearn, S / Doyle, E / Beijnen, J H / ten Bokkel Huinink, W W

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology

    1999  Volume 17, Issue 3, Page(s) 747–755

    Abstract: Purpose: To evaluate the feasibility of administering topotecan in combination with paclitaxel and cisplatin without and with granulocyte colony-stimulating factor (G-CSF) support as first-line chemotherapy in women with incompletely resected stage III ... ...

    Abstract Purpose: To evaluate the feasibility of administering topotecan in combination with paclitaxel and cisplatin without and with granulocyte colony-stimulating factor (G-CSF) support as first-line chemotherapy in women with incompletely resected stage III and stage IV ovarian carcinoma.
    Patients and methods: Starting doses were paclitaxel 110 mg/m2 administered over 24 hours (day 1), followed by cisplatin 50 mg/m2 over 3 hours (day 2) and topotecan 0.3 mg/m2/d over 30 minutes for 5 consecutive days (days 2 to 6). Treatment was repeated every 3 weeks. After encountering dose-limiting toxicities (DLTs) without G-CSF support, the maximum-tolerated dose was defined as 5 microg/kg of G-CSF subcutaneously starting on day 6.
    Results: Twenty-one patients received a total of 116 courses at four different dose levels. The DLT was neutropenia. At the first dose level, all six patients experienced grade 4 myelosuppression. G-CSF support permitted further dose escalation of cisplatin and topotecan. Nonhematologic toxicities, primarily fatigue, nausea/vomiting, and neurosensory neuropathy, were observed but were generally mild. Of 15 patients assessable for response, nine had a complete response, four achieved a partial response, and two had stable disease.
    Conclusion: Neutropenia was the DLT of this combination of paclitaxel, cisplatin, and topotecan. The recommended phase II dose is paclitaxel 110 mg/m2 (day 1), followed by cisplatin 75 mg/m2 (day 2) and topotecan 0.3 mg/m2/d (days 2 to 6) with G-CSF support repeated every 3 weeks.
    MeSH term(s) Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Blood Cell Count ; Cisplatin/administration & dosage ; Cisplatin/pharmacokinetics ; Fatigue/chemically induced ; Female ; Granulocyte Colony-Stimulating Factor/administration & dosage ; Humans ; Infusions, Intravenous ; Middle Aged ; Nausea/chemically induced ; Neoplasm Staging ; Neutropenia/chemically induced ; Ovarian Neoplasms/drug therapy ; Ovarian Neoplasms/pathology ; Paclitaxel/administration & dosage ; Paclitaxel/pharmacokinetics ; Thrombocytopenia/chemically induced ; Topotecan/administration & dosage ; Topotecan/pharmacokinetics
    Chemical Substances Granulocyte Colony-Stimulating Factor (143011-72-7) ; Topotecan (7M7YKX2N15) ; Paclitaxel (P88XT4IS4D) ; Cisplatin (Q20Q21Q62J)
    Language English
    Publishing date 1999-03
    Publishing country United States
    Document type Clinical Trial ; Clinical Trial, Phase I ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 604914-x
    ISSN 1527-7755 ; 0732-183X
    ISSN (online) 1527-7755
    ISSN 0732-183X
    DOI 10.1200/JCO.1999.17.3.747
    Database MEDical Literature Analysis and Retrieval System OnLINE

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