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
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
Robert L. DeJager, MD, FACP
United States: Federal Government
|University of New Mexico Cancer Research and Treatment Center||Albuquerque, New Mexico 87131|
|Herbert Irving Comprehensive Cancer Center at Columbia University||New York, New York 10032|