Phase
Condition
Digestive System Neoplasms
Gastric Cancer
Stomach Cancer
Treatment
N/AClinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
DISEASE CHARACTERISTICS:
Histologically confirmed gastric carcinoma not amenable to curative surgery or in relapse after primary surgical resection
Locally advanced disease (i.e., measurable locoregional lymph nodes) OR
Metastatic disease
Bidimensionally measurable disease
At least 10 mm X 20 mm by chest x-ray or physical examination
At least 10 mm X 10 mm by CT scan
No CNS metastasis
PATIENT CHARACTERISTICS:
Age:
- 18 to 70
Performance status:
- 0-1
Life expectancy:
- Greater than 12 weeks
Hematopoietic:
WBC count at least 4,000/mm^3
Platelet count at least 100,000/mm^3
Hepatic:
Bilirubin no greater than 1.25 times upper limit of normal (ULN)
AST/ALT no greater than 2.5 times ULN
Alkaline phosphatase no greater than 5 times ULN
Renal:
BUN normal
Creatinine normal
Creatinine clearance at least 60 mL/min
No severe hypercalcemia
Cardiovascular:
No unstable cardiac disease requiring treatment
No congestive heart failure
No angina pectoris even if medically controlled
No significant arrhythmias
No prior myocardial infarction unless ejection fraction at least 50% by MUGA scan or echocardiogram
Neurologic:
No prior significant neurologic or psychiatric disorders, including psychotic disorders, dementia or seizures that would preclude study
No peripheral neuropathy of any origin (alcohol, etc.) greater than grade 1
Other:
Fertile patients must use adequate contraception
No prior malignancy except basal cell skin cancer or adequately treated carcinoma in situ of the cervix
No active uncontrolled infection
No other serious illness or medical condition that would preclude study participation
No contraindication to corticosteroid use
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
No prior palliative chemotherapy
At least 12 months since prior adjuvant or neoadjuvant chemotherapy
No prior taxanes
Prior fluorouracil allowed in bolus form only
Prior cumulative dose of adjuvant or neoadjuvant cisplatin no greater than 300 mg/m2
Endocrine therapy:
- Prior or concurrent prednisone (or equivalent) allowed for prophylaxis, acute hypersensitivity reactions, or chronic therapy (greater than 6 months) at doses no greater than 20 mg
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
Other:
No other concurrent experimental drugs
No other concurrent anticancer therapies
At least 30 days since treatment in prior clinical trial
Study Design
Study Description
Connect with a study center
Hopital Cantonal Universitaire de Geneva
Geneva, CH-1211
SwitzerlandSite Not Available

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