Gastric Cancer Clinical Trial
Official title:
A Phase II Study of Epothilone Analog BMS-247550 in Patients With Metastatic Gastric Adenocarcinoma Previously Treated With a Taxane
Verified date | April 2013 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | January 2003 |
Est. primary completion date | January 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb | National Cancer Institute (NCI) |
United States,
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