BMS-247550 in Treating Patients With Metastatic Stomach Cancer Previously Treated With Chemotherapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study of Epothilone Analog BMS-247550 in Patients With Metastatic Gastric Adenocarcinoma Previously Treated With a Taxane

Conditions
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Esophageal Cancer, Gastric Cancer

Intervention / Treatment
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* Drug: ixabepilone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ixabepilone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV gastric cancer, recurrent gastric cancer, stage IV esophageal cancer, recurrent esophageal cancer, adenocarcinoma of the stomach, adenocarcinoma of the esophagus