A pharmacokinetic interaction study of docetaxel and cisplatin plus or minus 5-fluorouracil in the treatment of patients with recurrent or metastatic solid tumors

Cancer Chemotherapy and Pharmacology

Volumn 58, Issue 5, 2006, Pages 673-680

  Felici, A ^a,b   Loos, W J ^a   Verweij, J ^a   Cirillo, I ^c   De Bruijn, P ^a   Nooter, K ^a   Mathijssen, R H J ^a   De Jonge, M J A ^a  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b REGINA ELENA NATIONAL CANCER INSTITUTE   (Italy)

^c SANOFI   (France)

Author keywords

5 Fluorouracil; Cisplatin; Docetaxel; Pharmacokinetics

Indexed keywords

CISPLATIN; DEXAMETHASONE; DOCETAXEL; FLUOROURACIL; GRANISETRON; PLATINUM DERIVATIVE;

ABDOMINAL CRAMP; ADULT; ANOREXIA; ARTICLE; CANCER PATIENT; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIARRHEA; DRUG CLEARANCE; DRUG SAFETY; DRUG TOLERABILITY; DRUG USE; FEBRILE NEUTROPENIA; FEMALE; FLU LIKE SYNDROME; FREQUENCY ANALYSIS; HEART MUSCLE ISCHEMIA; HUMAN; LETHARGY; LEUKOPENIA; MALE; METASTASIS; NAUSEA; NEUROTOXICITY; NEUTROPENIA; PAIN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECURRENT CANCER; SOLID TUMOR; SOMNOLENCE; STATISTICAL SIGNIFICANCE; STOMATITIS; VOMITING;

ADULT; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; AREA UNDER CURVE; CISPLATIN; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; FLUOROURACIL; HALF-LIFE; HUMANS; INFUSIONS, INTRAVENOUS; LEUKOPENIA; MALE; MIDDLE AGED; NEOPLASM METASTASIS; NEOPLASM RECURRENCE, LOCAL; NEOPLASMS; NEUTROPENIA; TAXOIDS; TREATMENT OUTCOME;

EID: 33746770967     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-006-0221-x     Document Type: Article

References (33)

1. Colevas AD, Busse PM, Norris CM et al (1998) Induction chemotherapy with docetaxel, cisplatin, fluorouracil, and leucovorin for squamous cell carcinoma of the head and neck: a phase I/II trial. J Clin Oncol 16:1331-1339
2. Colevas AD, Norris CM, Tisheler RB et al (1999) Phase II of docetaxel, cisplatin, fluorouracil, and leucovorin as induction for squamous cell carcinoma of the head and neck. J Clin Oncol 17:3503-3511
3. Posner MR, Glisson B, Frenette G et al (2001) Multicenter phase I-II trial of docetaxel, cisplatin, and fluorouracil induction chemotherapy for patients with locally advanced squamous cell cancer of the head and neck. J Clin Oncol 19:1096-1104
4. Janinis J, Papadakou M, Panagos G et al (2001) Sequential chemotherapy with docetaxel, cisplatin, and 5-fluorouracil in patients with locally advanced head and neck cancer. Am J Clin Oncol 24:227-231
5. Haddad R, Tishler RB, Norris CM et al (2003) Docetaxel, cisplatin, 5-fluorouracil (tpf)-based induction chemotherapy for head and neck cancer and the case for sequential, combined-modality treatment. Oncologist 8:35-44
6. Schrijvers D, Van Herpen C, Kerger J et al (2004) Docetaxel, cisplatin and 5-fluorouracil in patients with locally advanced unresectable head and neck cancer: a phase I-II feasibility study. Ann Oncol 15:638-645
7. Roth AD, Maibach R, Fazio N et al (2004) 5-Fluorouracil as protracted continuous intravenous infusion can be added to full-dose docetaxel (Taxotere)-cisplatin in advanced gastric carcinoma: a phase I-II trial. Ann Oncol 15:759-764
8. Ringel I, Horowitz S (1991) Studies with RP 56976 (Taxotere): a semisynthetic analog of taxol. J Natl Cancer Inst 83:288-291
9. Bissery MC (1995) Preclinical pharmacology of docetaxel. Eur J Cancer 31A(Suppl 4):S1-S6
10. 1-acid glycoprotein. Invest New Drugs 14:1547-1551
11. Schellens JHM, Ma J, Planting ASTh et al (1996) Relationship between the exposure to cisplatin, DNA-adduct formation in leucocytes and tumour response in patients with solid tumours. Br J Cancer 74:323-326
12. Leichman CG, Fleming TR, Muggia F et al (1995) Phase II study of fluorouracil and its modulation in advanced colorectal cancer: a Southwest Oncology Group Study. J Clin Oncol 13:1303-1311
13. Pronk LC, Schellens JHM, Planting ASTh et al (1997) Phase I and pharmacologic study of docetaxel and cisplatin in patients with advanced solid tumors. J Clin Oncol 15:1071-1079
14. Van Den Neste E, de Valeriola D, Kerger J et al (2000) A phase I and pharmacokinetic study of docetaxel administered in combination with continuous intravenous infusion of 5-fluorouracil in patients with advanced solid tumors. Clin Cancer Res 6:64-71
15. Ando M, Watanabe T, Sasaki Y et al (1998) A phase I trial of docetaxel and 5-day continuous infusion of 5-fluorouracil in patients with advanced or recurrent breast cancer. Br J Cancer 77:1937-1943
16. Loos WJ, Verweij J, Nooter K et al (1997) Sensitive determination of docetaxel in human plasma by liquid-liquid extraction and reverse-phase high-performance liquid chromatography. J Chromatogr B 963:437-441
17. Ma J, Verweij J, Planting AST et al (1995) Current sample handling methods for measurement of platinum-DNA adducts in leucocytes in man lead to discrepant results in DNA adduct levels and DNA repair. Br J Cancer 71:512-517
18. Loos WJ, de Bruijn P, van Zuylen L et al (1999) Determination of 5-fluorouracil in microvolumes of human plasma by solvent extraction and high-performance liquid chromatography. J Chromatogr B Biomed Sci Appl 735:293-297
19. Launay-Iliadis MC, Bruno R, Cosson V et al (1995) Population pharmacokinetics of docetaxel during phase I studies using nonlinear mixed-effect modelling and nonparametric maximum-likelihood estimation. Cancer Chemother Pharmacol 37:47-54
20. Casale F, Canapro R, Serpe L et al (2004): Plasma concentrations of 5-fluorouracil and its metabolites in colon cancer patients. Pharmacol Res 50:173-179
21. Minami H, Ohe Y, Niho S et al (2004) Comparison of pharmacokinetics and pharmacodynamics of docetaxel and cisplatin in elderly and non-elderly patients: why is toxicity increased in elderly patients? J Clin Oncol 22:2901-2908
22. Bruno R, Vivier N, Vergniol JC et al (1996) A population pharmacokinetic model for docetaxel (Taxotere): model building and validation. J Pharmacokinet Biopharm 24:153-172
23. Bruno R, Vivier N, Veyrat-Follet C, Montay G, Rhodes G (2001) Population pharmacokinetics and pharmacokinetic-pharmacodynamic relationships for docetaxel. Invest New Drugs 19:163-169
24. Bissery M, Vrignaud P, Lavelle F (1995) Preclinical profile of docetaxel (Taxotere): efficacy as single agent and in combination. Semin Oncol 22(Suppl 13):3-16
25. Ajani JA, Fodor M, Van Cutsem E et al (2005) Multinational randomized phase II trial of docetaxel (T) and cisplatin (C) with or without 5-fluorouracil (FU) in patients (Pts) with advanced gastric or GE junction adenocarcinoma (AGC-AGEJC). J Clin Oncol 23:5660-5667
26. Ajani JA, Van Cutsem E, Moiseyenko V et al (2003) Docetaxel (D), cisplatin, 5-fluorouracil compared with cisplatin (C) and 5-fluorouracil (F) for chemotherapy-naïve patients with metastatic or locally recurrent, unresectable gastric carcinoma (MGC): interim results of a randomized phase III trials (V325). Proc Am Soc Clin Oncol A #999
27. Roth AD, Maibach R, Falk S et al (2004) Docetaxel-cisplatin-5FU (TCF) versus docetaxel-cisplatin (TC) versus epirubicin-cisplatin-5FU (ECF) as systemic treatment for advanced gastric carcinoma (AGC): a randomized phase II trial of the Swiss Group for Clinical Research (SAKK). Proc Am Soc Clin Oncol 22(14S):4020
28. Yuki S, Komatsu Y, Machida N et al (2005) Phase I study of docetaxel, cisplatin and 5-fluorouracil (TPF) as first-line chemotherapy in patients with advanced esophageal cancer. Hokkaido Gastrointestinal Cancer Study Group (HGCSG) study. Proc Am Soc Clin Oncol 23:4181
29. Scanlon KJ, Newman EM, Lu Y et al (1986) Biochemical basis for cisplatin and 5-fluorouracil synergism in human ovarian carcinoma cells. Proc Natl Acad Sci 83:8923-8925
30. Scanlon KJ, Lu Y, Kashani-Sabet M et al (1988) Mechanisms for cisplatin-Fura synergism and cisplatin resistance in human ovarian carcinoma cells in vitro and in vivo. Adv Exp Med Biol 244:127-135
31. Crul M, van Waardenburg RCAM, Beijnen JH, Schellens JHM (2002) DNA-based drug interactions of cisplatin. Cancer Treat Rev 28:291-303
32. Ma J, Verweij J, Planting AST et al (1996) Docetaxel and paclitaxel inhibit DNA-adduct formation and intracellular accumulation of cisplatin in human leukocytes. Cancer Chemother Pharmacol 37:382-384
33. McLeod HL (1998) Clinically relevant drug-drug interaction in oncology. Br J Clin Pharmacol 45:539-544