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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer; Esophageal Cancer

Treatments: Drug: ixabepilone

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00017043

CDR0000068644

BMS-MSKCC-01011

NCI-G01-1949

MSKCC-01011

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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