Phase I Study of Bryostatin 1 and Gemcitabine (Gemzar)
- 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.
Primary Purpose: Treatment
Philip A. Philip, MD, PhD, FRCP
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|