irofulven in treating patients with recurrent or metastatic gastric cancer

Conditions: Gastric Cancer

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.

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.

Eligibility 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

Keywords: recurrent gastric cancer stage iv gastric cancer adenocarcinoma of the stomach