Irofulven in Treating Patients With Recurrent or Metastatic Gastric Cancer
- Conditions
- Gastric Cancer
- Registration Number
- NCT00062257
- Lead Sponsor
- Cancer Therapeutics Research Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Yonsei Cancer Center at Yonsei University Medical Center
🇰🇷Seoul, Korea, Republic of
Sydney Cancer Centre at Royal Prince Alfred Hospital
🇦🇺Sydney, New South Wales, Australia
Johns Hopkins - Singapore
🇸🇬Singapore, Singapore
Cancer Institute at National University Hospital
🇸🇬Singapore, Singapore
National Cancer Centre - Singapore
🇸🇬Singapore, Singapore
Prince of Wales Hospital
ðŸ‡ðŸ‡°Shatin, New Territories, Hong Kong