NCT00084734

Docetaxel, Capecitabine, and Cisplatin in Treating Patients With Advanced Solid Tumors

A Phase I and Pharmacokinetics Study of Docetaxel in Combination With Capecitabine and Cisplatin in Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, capecitabine, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel, capecitabine, and cisplatin in treating patients with metastatic or unresectable solid tumors.

Detailed description

OBJECTIVES: Primary * Determine the maximum tolerated dose of docetaxel, cisplatin, and capecitabine in patients with advanced solid tumors. * Determine the dose-limiting toxicity and recommended phase II dose of this regimen in these patients. Secondary * Determine the non-dose-limiting toxic effects associated with this regimen in these patients. * Determine the pharmacokinetics of this regimen in these patients. * Determine any clinical activity of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive docetaxel IV over 30 minutes and cisplatin IV over 30 minutes on days 1 and 8 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of docetaxel, cisplatin, and capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients receive treatment at the MTD. PROJECTED ACCRUAL: A minimum of 21 patients will be accrued for this study within 1.5 years.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	capecitabine	Oral
DRUG	cisplatin	IV
DRUG	docetaxel	IV

Timeline

• Start date: 2002-05-01
• Primary completion: 2009-11-01
• Completion: 2009-12-01
• First posted: 2004-06-11
• Last updated: 2023-08-04

Locations

1 site across 1 country: United States