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

NCT ID: NCT00017043

Last Updated: 2013-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-02-28
• Study Completion Date: 2003-01-31

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.

Conditions

Esophageal Cancer; Gastric Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

ixabepilone

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Principal Investigators

Manish A. Shah, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

BMS-MSKCC-01011

Identifier Type: -

Identifier Source: secondary_id

MSKCC-01011

Identifier Type: -

Identifier Source: secondary_id

NCI-G01-1949

Identifier Type: -

Identifier Source: secondary_id

CDR0000068644

Identifier Type: -

Identifier Source: org_study_id