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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000304669 | Registry Identifier | PDQ (Physician Data Query) | |
| NCI-6041 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| irofulven | Drug |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed gastric adenocarcinoma
Measurable disease
No known brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Winnie Yeo | Prince of Wales Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sydney Cancer Centre at Royal Prince Alfred Hospital | Sydney | New South Wales | 2050 | Australia | ||
| Prince of Wales Hospital |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C102714 | irofulven |
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| Shatin, New Territories |
| Hong Kong |
| Cancer Institute at National University Hospital | Singapore | 119074 | Singapore |
| Johns Hopkins - Singapore | Singapore | 119074 | Singapore |
| National Cancer Centre - Singapore | Singapore | 169610 | Singapore |
| Yonsei Cancer Center at Yonsei University Medical Center | Seoul | 120-752 | South Korea |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |