Pancreatic Cancer Clinical Trial
Official title:
A Phase II Trial of MGI 114 in Patients With Advanced Pancreatic Adenocarcinoma
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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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