Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I Study of 17-N-Allylamino-17-Demethoxy Geldanamycin (17-AAG, NSC# 330507) in Combination With Docetaxel in Patients With Advanced Solid Tumors
This phase I trial is studying the side effects and best dose of combination chemotherapy in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy, such as docetaxel and 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
OBJECTIVES:
I. Determine the maximum tolerated dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG)
administered with docetaxel in patients with progressive metastatic prostate cancer or other
progressive metastatic or unresectable solid tumors.
II. Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a dose-escalation study of 17-N-allylamino-17-demethoxygeldanamycin
(17-AAG). Patients are assigned to 1 of 2 treatment groups.
Group 1: Patients receive docetaxel IV over 1 hour and 17-AAG IV over 1-2 hours on day 1.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group 2: Patients receive docetaxel IV over 30 minutes and 17-AAG as in group 1. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients per group receive escalating doses of 17-AAG 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. Up to 20 additional patients (10
per group) are treated at the MTD.
Patients are followed every 2-3 months.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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