Soblidotin and Gemcitabine in Treating 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.
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: gemcitabine Drug: soblidotin Procedure: chemotherapy||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Study of Soblidotin and Gemcitabine in Patients With Locally Advanced or Metastatic Solid Tumors|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00072228
|United States, New Mexico|
|University of New Mexico Cancer Research and Treatment Center|
|Albuquerque, New Mexico, United States, 87131-5636|
|United States, New York|
|Herbert Irving Comprehensive Cancer Center at Columbia University|
|New York, New York, United States, 10032|
|Study Chair:||Robert L. DeJager, MD, FACP||Daiichi Pharmaceuticals|