Gastric Cancer
Conditions
Keywords
recurrent gastric cancer, stage IV gastric cancer, adenocarcinoma of the stomach
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.
Interventions
DRUGirofulven
Sponsors
National Cancer Institute (NCI)
Cancer Therapeutics Research Group
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed gastric adenocarcinoma * Recurrent or metastatic disease * Adenocarcinoma of the gastroesophageal junction eligible provided the majority of tumor bulk is below the junction * Measurable disease * At least 1 lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * No known brain metastases PATIENT CHARACTERISTICS: Age * Over 18 Performance status * ECOG 0-2 Life expectancy * More than 3 months Hematopoietic * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * No active disseminated intravascular coagulation Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST/ALT no greater than 2.5 times ULN (5 times ULN for patients with liver metastases) * Alkaline phosphatase no greater than 5 times ULN Renal * Creatinine no greater than 1.5 times ULN Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior allergic reaction attributed to compounds of similar chemical or biological composition to irofulven * No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer * No other uncontrolled concurrent illness that would preclude study participation * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * Must have central or peripherally inserted central catheter PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa Chemotherapy * No prior chemotherapy for recurrent or metastatic disease * Prior adjuvant or neoadjuvant chemotherapy allowed provided disease relapsed more than 6 months after therapy Endocrine therapy * Not specified Radiotherapy * More than 4 weeks since prior radiotherapy and recovered Surgery * Not specified Other * No other concurrent investigational or commercial agents or therapies for the malignancy * No concurrent combination antiretroviral therapy for HIV-positive patients
Countries
Australia, Hong Kong, Singapore, South Korea
Outcome results
None listed