Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00017043


Primary Contact:

Study Chair
Manish A. Shah, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

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