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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT00017043

Collaborator

National Cancer Institute (NCI) (NIH)

Location

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer Gastric Cancer	Drug: ixabepilone	Phase 2

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2001

Actual Primary Completion Date :

Jan 1, 2003

Actual Study Completion Date :

Jan 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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