Bryostatin 1 Plus Gemcitabine in Treating Patients With Advanced Cancer
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|ClinicalTrials.gov Identifier: NCT00004144|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 24, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: bryostatin 1 Drug: gemcitabine hydrochloride||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Bryostatin 1 and Gemcitabine (Gemzar)|
|Study Start Date :||May 2000|
|Primary Completion Date :||December 2006|
|Study Completion Date :||December 2006|
|Experimental: bryostatin 1 & gemcitabine hydrochloride||Drug: bryostatin 1 Drug: gemcitabine hydrochloride|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|