Gastric Cancer Clinical Trial
Official title:
A Phase II Study of Irofulven as First Line Therapy in Recurrent or Metastatic Gastric Cancer
RATIONALE: Drugs used in chemotherapy, such as irofulven, use different ways to stop tumor
cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well irofulven works in treating patients with
recurrent or metastatic gastric cancer.
OBJECTIVES:
- Determine the response rate of patients with recurrent or metastatic gastric cancer
treated with irofulven.
- Determine the toxicity profile of this drug in these patients.
- Determine the overall survival of patients treated with this drug.
OUTLINE: This is a non-randomized, open-label, multicenter study.
Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 3 weeks
in the absence of disease progression, unacceptable toxicity, or static disease after 4
courses in the absence of clinical benefit.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 5-9
months.
;
Masking: Open Label, Primary Purpose: Treatment
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