Overview

BMS-247550 in Treating Patients With Recurrent Metastatic Stomach Cancer That Has Been Previously Treated With Chemotherapy

Status:
Completed
Trial end date:
2002-01-01
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 recurrent metastatic stomach cancer that has been previously treated with chemotherapy.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborator:
National Cancer Institute (NCI)
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed recurrent metastatic adenocarcinoma of
the stomach or gastroesophageal junction No squamous cell or sarcomatous elements in tumor
Previously treated with 1 prior fluoropyrimidine and/or platinum based chemotherapy regimen
for metastatic disease OR Recurrent disease within 6 months of completing adjuvant
fluoropyrimidine-containing therapy Bidimensionally measurable disease No known brain
metastases

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/mm3 Platelet count
greater than 125,000/mm3 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 grade 2 or
greater neuropathy (motor or sensory) No other malignancy within the past 2 years except
nonmelanoma skin cancer or carcinoma in situ of the cervix No serious concurrent infection
No other medical illness that would preclude study No psychiatric disorder or other
condition that would preclude study No known hypersensitivity to Cremophor EL Not pregnant
or nursing Negative pregnancy test Fertile patients must use effective contraception during
and for 2 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: See
Disease Characteristics At least 3 weeks since prior chemotherapy Prior adjuvant or
neoadjuvant chemotherapy allowed No more than 1 prior chemotherapy regimen for metastatic
disease No prior taxane therapy No other concurrent chemotherapy Endocrine therapy: No
concurrent hormonal therapy except hormone replacement therapy Radiotherapy: At least 3
weeks since prior radiotherapy and recovered No prior radiotherapy to major bone
marrow-containing areas (pelvis, lumbar spine) or to only site of measurable disease 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