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

• Status: Completed
• Trial end date: 2003-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: National Cancer Institute (NCI)

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