Spots Global Cancer Trial Database for Irofulven in Treating Patients With Recurrent or Metastatic Gastric Cancer

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Trial Identification

Brief Title: Irofulven in Treating Patients With Recurrent or Metastatic Gastric Cancer

Official Title: A Phase II Study of Irofulven as First Line Therapy in Recurrent or Metastatic Gastric Cancer

Study ID: NCT00062257

Conditions

Gastric Cancer

Interventions

irofulven

Study Description

Brief Summary: 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.

Detailed Description: 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.