Phase II Study of Dolastatin 10 (NSC# 376128) Administered Intravenously Every 21 Days to Patients With Metastatic Pancreatic Adenocarcinoma
OBJECTIVES: I. Assess the antitumor activity of dolastatin 10 in patients with metastatic
adenocarcinoma of the pancreas. II. Evaluate the qualitative and quantitative toxic effects
of this therapy in these patients. III. Investigate the clinical pharmacology of this
OUTLINE: This is an open label, multicenter study. Patients receive dolastatin 10 IV bolus
once every 21 days. Treatment continues in the absence of disease progression or
unacceptable toxicity. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: This study will accrue 12-37 patients within 18.5 months.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with Toxicity
Toxic effects of dolastatin 10 therapy in patients with metastatic adenocarcinoma of the pancreas used to assess antitumor activity.
Every 3 months
Hedy L. Kindler, MD
University of Chicago
United States: Federal Government
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|