Irofulvene in Treating Patients With Stage III or Stage IV 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 irofulven in treating patients who have stage III or stage IV pancreatic cancer that cannot be surgically removed.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of MGI 114 in Patients With Advanced Pancreatic Adenocarcinoma|
|Study Start Date:||November 1998|
|Study Completion Date:||May 2000|
|Primary Completion Date:||May 2000 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the survival rate at 6 months of patients with stage III or IV unresectable adenocarcinoma of the pancreas treated with 6-hydroxymethylacylfulvene (MGI 114). II. Determine the objective tumor response rate, time to objective tumor response, and duration of response in these patients (if retrospective data is available, time to tumor progression while on prior gemcitabine is determined). III. Determine the clinical benefit of MGI 114 as measured by pain improvement, performance status, and weight. IV. Determine the survival rate at 3, 9, and 12 months in these patients. V. Gain additional information on the toxic effects and safety profile of this regimen.
OUTLINE: This is an open label, multicenter study. Patients receive 6-hydroxymethylacylfulvene (MGI 114) IV over 5 minutes on days 1-5. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for up to 1 year after therapy initiation.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 12-18 months.
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198-3330|
|United States, Texas|
|Brooke Army Medical Center|
|Fort Sam Houston, Texas, United States, 78234|
|San Antonio Cancer Institute|
|San Antonio, Texas, United States, 78229|
|Study Chair:||Eric K. Rowinsky, MD||San Antonio Cancer Institute|