bms-247550 in treating patients with metastatic stomach cancer previously treated with chemotherapy

Conditions: Esophageal Cancer; Gastric Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of bms-247550 in treating patients who have metastatic stomach cancer previously treated with chemotherapy.

objectives: * determine the clinical activity of bms-247550, in terms of response rate, in patients with previously treated metastatic gastric adenocarcinoma. * determine the safety of this drug in these patients. * assess the response duration, time to progression, and survival of patients treated with this drug. outline: this is a multicenter study. patients receive bms-247550 iv over 1 hour on day 1. treatment repeats every 21 days for 2-18 courses in the absence of disease progression or unacceptable toxicity. patients with a complete response (cr) receive 4 additional courses after confirmation of cr. patients are followed every 3 months. projected accrual: a total of 21-58 patients will be accrued for this study within 1 year.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma originating in the stomach or gastroesophageal junction * failed prior taxane-based chemotherapy regimen\* in the metastatic setting or * relapsed within 6 months of completing taxane-based chemotherapy\* in the adjuvant setting * bidimensionally measurable metastatic disease * no prior radiotherapy to only measurable target lesion * no squamous cell or sarcomatous disease * no known brain metastases note: \*regimen must have included a fluopyrimidine and/or a platinum drug patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * at least 12 weeks hematopoietic: * absolute neutrophil count at least 2,000/mm\^3 * platelet count greater than 125,000/mm\^3 hepatic: * bilirubin no greater than 1.5 times upper limit of normal (uln) * alt no greater than 2.5 times uln (5 times uln if liver metastases present) renal: * creatinine no greater than 2 times uln cardiovascular: * no unstable angina, myocardial infarction, or congestive heart failure within the past 6 months other: * no other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * no serious concurrent infection * no nonmalignant uncontrolled medical illness that would preclude study * no psychiatric disorder or other condition that would preclude study compliance * no neuropathy (neuromotor or neurosensory) of grade 2 or greater * no known severe hypersensitivity to agents containing cremophor el * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 2 months after the study prior concurrent therapy: biologic therapy: * no concurrent immunotherapy chemotherapy: * see disease characteristics * at least 3 weeks since prior chemotherapy for metastatic disease * prior neoadjuvant and adjuvant chemotherapy allowed * no more than 1 prior chemotherapy regimen for metastatic disease * no other concurrent chemotherapy endocrine therapy: * no concurrent hormonal therapy except hormone replacement therapy radiotherapy: * see disease characteristics * at least 3 weeks since prior radiotherapy and recovered * no prior radiotherapy to major bone marrow-containing areas (e.g., pelvis or lumbar spine) * no concurrent therapeutic radiotherapy surgery: * at least 1 week since prior minor surgery and recovered * at least 3 weeks since prior major surgery and recovered other: * no other concurrent experimental anticancer medications

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