Esophageal Cancer, Gastric Cancer
Conditions
Keywords
stage IV gastric cancer, recurrent gastric cancer, stage IV esophageal cancer, recurrent esophageal cancer, adenocarcinoma of the stomach, adenocarcinoma of the esophagus
Brief 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.
Detailed description
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.
Interventions
DRUGixabepilone
Sponsors
National Cancer Institute (NCI)
Bristol-Myers Squibb
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed