A phase I dose finding study of cisplatin, gemcitabine, and weekly docetaxel for patients with advanced transitional cell cancer.

Abstract

OBJECTIVE:

Efficacious regimens are needed for the treatment of metastatic bladder cancer. The aim of this study was to determine the toxicity and phase II dose of a triplet regimen of cisplatin, gemcitabine, and weekly docetaxel for patients with advanced transitional cell carcinoma.

METHODS:

Thirteen patients were enrolled to the study: 3 to dose level 1 (cisplatin 70 mg/m2 on day 1; gemcitabine 1000 mg/m2, day 1 and 8; and docetaxel 30 mg/m2, day 1 and 8, every 21 days), and 10 to dose level -1 (cisplatin 70 mg/m2 on day 1; gemcitabine 800 mg/m2, day 1 and 8; and docetaxel 30 mg/m2, day 1 and 8, every 21 days).

RESULTS:

Grade 3-4 hematologic toxicities included neutropenia (40%) and thrombocytopenia (20%). Grade 3 nonhematologic toxicity was restricted to diarrhea. There were 2 early deaths: 1 from a suspected pulmonary embolism and another from sepsis. In 11 patients who received > or =2 cycles the response rate was 73%.

CONCLUSIONS:

The recommended phase II dose of this triplet regimen in advanced transitional cell carcinoma is cisplatin 70 mg/m2 on day 1; gemcitabine 800 mg/m2 day 1 and 8; and docetaxel 30 mg/m2 day 1 and 8, repeated every 21 days. The preliminary objective response rate was high in this cohort of patients.

• Authors: Anna Tinker, Eric Winquist, Christina Canil, Malcolm Moore, R Nevin Murray, Kim N Chi
• Journal: American journal of clinical oncology (Am J Clin Oncol) Vol. 29 Issue 1 Pg. 3-7 (Feb 2006) ISSN: 1537-453X [Electronic] United States
• PMID: 16462494 (Publication Type: Clinical Trial, Phase I, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Taxoids
• Deoxycytidine
• Docetaxel
• Cisplatin
• Gemcitabine

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Carcinoma, Transitional Cell (drug therapy)
• Cisplatin (administration & dosage)
• Deoxycytidine (administration & dosage, analogs & derivatives)
• Docetaxel
• Female
• Humans
• Infusions, Intravenous
• Maximum Tolerated Dose
• Middle Aged
• Taxoids (administration & dosage)
• Urinary Bladder Neoplasms (drug therapy)
• Gemcitabine