Dolastatin 10 in Treating Patients With Metastatic Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of dolastatin 10 in treating patients who have metastatic pancreatic cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Dolastatin 10 (NSC# 376128) Administered Intravenously Every 21 Days to Patients With Metastatic Pancreatic Adenocarcinoma|
- Number of Patients with Toxicity [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]Toxic effects of dolastatin 10 therapy in patients with metastatic adenocarcinoma of the pancreas used to assess antitumor activity.
|Study Start Date:||March 1999|
|Study Completion Date:||January 2002|
|Primary Completion Date:||January 2002 (Final data collection date for primary outcome measure)|
Experimental: Dolastatin 10
Dolastatin 10 IV bolus once every 21 days.
Drug: Dolastatin 10
IV bolus once every 21 days.
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 treatment.
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.
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637|
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Hedy L. Kindler, MD||University of Chicago|