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