Bryostatin 1 Plus Gemcitabine in Treating Patients With Advanced Cancer
RATIONALE: Drugs used in chemotherapy 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: Phase I trial to study the effectiveness of bryostatin 1 plus gemcitabine in treating patients who have advanced cancer that has not responded to previous treatment.
Unspecified Adult Solid Tumor, Protocol Specific
Drug: bryostatin 1
Drug: gemcitabine hydrochloride
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Bryostatin 1 and Gemcitabine (Gemzar)|
|Study Start Date:||May 2000|
|Study Completion Date:||December 2006|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
|Experimental: bryostatin 1 & gemcitabine hydrochloride||Drug: bryostatin 1 Drug: gemcitabine hydrochloride|
- Determine the maximum tolerated dose of gemcitabine when given concurrently with bryostatin 1 to patients with advanced refractory cancer.
- Access the pattern of toxicity of this drug regimen in this patient population.
- Determine the objective response rate, duration of response, and overall survival in patients treated with this drug regimen.
- Determine the influence of bryostatin 1 on the pharmacokinetics of gemcitabine.
OUTLINE: This is a dose escalation study.
Patients receive gemcitabine IV over 30 minutes, immediately followed by bryostatin 1 IV over 24 hours, weekly for 3 weeks (days 1, 8, and 15). Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of gemcitabine and bryostatin 1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxic effects.
PROJECTED ACCRUAL: Approximately 2-3 patients per month will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004144
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|Study Chair:||Philip A. Philip, MD, PhD, FRCP||Barbara Ann Karmanos Cancer Institute|