NCT00072228

Soblidotin and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors

Phase I Study of Soblidotin and Gemcitabine in Patients With Locally Advanced or Metastatic Solid Tumors

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Daiichi Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	gemcitabine
DRUG	soblidotin
PROCEDURE	chemotherapy

Timeline

• First posted: 2003-11-06
• Last updated: 2013-07-10

Locations

2 sites across 1 country: United States