Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase I Study of Soblidotin and Gemcitabine in Patients With Locally Advanced or Metastatic Solid Tumors
RATIONALE: Drugs used in chemotherapy, such as soblidotin and gemcitabine, use different
ways to stop tumor cells from dividing so they stop growing or die. Combining more than one
drug may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of soblidotin and
gemcitabine in treating patients with locally advanced or metastatic solid tumors.
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of soblidotin and gemcitabine in patients with
locally advanced or metastatic solid tumors.
- Determine the dose-limiting toxic effects of this regimen in these patients.
Secondary
- Determine the toxicity profile of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine, preliminarily, the antitumor activity of this regimen in these patients.
OUTLINE: This is an open-label, nonrandomized, multicenter, dose-escalation study.
Patients receive gemcitabine IV over 30 minutes and soblidotin IV over 1 hour on days 1 and
8. Courses repeat every 3 weeks in the absence of disease progression or unacceptable
toxicity.
Cohorts of 3-6 patients receive escalating doses of soblidotin and gemcitabine 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.
Patients are followed for survival every 3 months after completion of study therapy.
PROJECTED ACCRUAL: Approximately 35 patients will be accrued for this study within 1 year.
;
Primary Purpose: Treatment
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