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.
- 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.
- Histologically confirmed adenocarcinoma originating in the stomach or
- Failed prior taxane-based chemotherapy regimen* in the metastatic setting OR
- Relapsed within 6 months of completing taxane-based chemotherapy* in the
- 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
- 18 and over
- ECOG 0-2
- At least 12 weeks
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count greater than 125,000/mm^3
- 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)
- Creatinine no greater than 2 times ULN
- No unstable angina, myocardial infarction, or congestive heart failure within the
past 6 months
- 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
PRIOR CONCURRENT THERAPY:
- No concurrent immunotherapy
- 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
- No concurrent hormonal therapy except hormone replacement therapy
- 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
- No concurrent therapeutic radiotherapy
- At least 1 week since prior minor surgery and recovered
- At least 3 weeks since prior major surgery and recovered
- No other concurrent experimental anticancer medications