Phase I dose-escalation trial of gemcitabine and cisplatin for advanced non-small-cell lung cancer: Usefulness of mathematic modeling to determine maximum-tolerable dose

Journal of Clinical Oncology

Volumn 14, Issue 5, 1996, Pages 1656-1662

  Shepherd, F A ^a   Burkes, R ^a   Cormier, Y ^a   Crump, M ^a   Feld, R ^a   Strack, T ^a   Schulz, M ^a  

^a UNIVERSITY HEALTH NETWORK   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; CISPLATIN; CREATININE; GEMCITABINE;

ADULT; ADVANCED CANCER; AGED; ARTICLE; ASTHENIA; BONE MARROW TOXICITY; CANCER STAGING; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG TOLERABILITY; FATIGUE; FEMALE; GASTROINTESTINAL TOXICITY; HUMAN; LIVER TOXICITY; LUNG NON SMALL CELL CANCER; LUNG TOXICITY; MALE; MATHEMATICAL MODEL; NEPHROTOXICITY; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL;

EID: 0029963324     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.1996.14.5.1656     Document Type: Article

References (19)

1. 1-diflurodeoxycytidine and 1-β-D-arabinofuranosylcytosine. Cancer Res 48:4024-4031, 1988
2. 1-deoxycytidine). Cancer Res 50:4417-4422, 1990
3. 1-Difluorodeoxycytidine (gemcitabine) incorporation into RNA and DNA of tumour cell lines. Biochem Pharmacol 46:762-766, 1993
4. 1-difluoro-deoxycytidine (gemcitabine). Cancer Treat Rev 19:45-55, 1993
5. Abbruzzese JL, Grunewald R, Weeks EA, et al: A phase I clinical, plasma and cellular pharmacology study of gemcitabine. J Clin Oncol 9:491-498, 1991
6. Eli Lilly: New Drug Submission. Canadian Comprehensive Summary Clinical Synopsis, Part 3, vol I. 1994, p 938
7. Anderson H, Lund B, Back F, et al: Single-agent activity of weekly gemcitabine and advanced non-small-cell lung cancer: A phase II study. J Clin Oncol 12:1821-1826, 1994
8. Abratt RP, Bezwoda WR, Falkson G, et al: Efficacy and safety profile of gemcitabine in non-small-cell lung cancer - A phase II study. J Clin Oncol 12:1535-1540, 1994
9. Shepherd FA, Gatzemeier U, Gotfried M, et al: An extended phase II study of gemcitabine in non-small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol 12:330, 1993 (abstr)
10. Bakowski MT, Crouch JD: Chemotherapy of non-small cell lung cancer: A reappraisal and a look to the future. Cancer Treat Rev 10:159-172, 1983
11. Peters G, Bergman AM, Veerman G, et al: Synergism between cisplatin (C-Pt) and gemcitabine in resistant A2780 human ovarian cancer cell lines is schedule dependent. Proc Am Soc Cancer Res 35:1950, 1994 (abstr)
12. O'Quigley J, Pepe M, Fisher L. Continual reassessment method: A practical design for phase I clinical studies in cancer. Biometrics 46:33-48, 1990
13. O'Quigley J: Estimating the probability of toxicity at the recommended dose following a phase I clinical trial in cancer. Biometrics 48:853-862, 1992
14. Donnadieu N, Paesmans M, Sculier JP: Chemotherapy of non-small cell lung cancer according to disease extent: A metaanalysis of the literature. Lung Cancer 7:243-252, 1991
15. Gralla RJ, Casper ES, Kelsen DP, et al: Cisplatin and vindesine combination chemotherapy for advanced carcinoma of the lung: A randomized trial investigating two dosage schedules. Ann Intern Med 95:414-420, 1981
16. Gandara DR, Tanaka MT, Krowley J, et al: Comparison of standard dose cisplatin, high-dose cisplatin and high-dose cisplatin plus mitomycin in metastatic non-small cell lung cancer: Preliminary results of a phase III study. Proc Am Soc Clin Oncol 10:246, 1991 (abstr)
17. Vogl SE, Berenzweig M, Camacho F, et al: Efficacy study of intensive cisplatin therapy in advanced non-small cell lung bronchogenic carcinoma. Cancer 50:24-26, 1982
18. Wilke H, Achterrath W, Gunzer U, et al: Etoposide and split-dose cisplatin therapy in non-small cell lung cancer. Proc Am Soc Clin Oncol 5:179, 1986 (abstr)
19. 2) in non-small cell lung: Reduced toxicity of a modified dose schedule. Proc Am Soc Clin Oncol 5:173, 1986 (abstr)