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

NCT00017043 | Completed Phase 2

• 4 other identifiers: CDR0000068644BMS-MSKCC-01011MSKCC-01011NCI-G01-1949
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer; Gastric Cancer

Keywords

stage IV gastric cancer; recurrent gastric cancer; stage IV esophageal cancer; recurrent esophageal cancer; adenocarcinoma of the stomach; adenocarcinoma of the esophagus

Interventions

ixabepilone DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Adenocarcinoma Of Esophagus

Interventions

ixabepilone

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Manish A. Shah, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 6, 2001
• First Posted: September 9, 2003
• Study Start: February 1, 2001
• Primary Completion: January 1, 2003
• Study Completion: January 1, 2003
• Last Updated: April 5, 2013

Record last verified: 2013-04

Locations

US (1)