Oxaliplatin and Capecitabine in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer (NCT00040859) | Clinical Trial Compass
CompletedPhase 2
Oxaliplatin and Capecitabine in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
United States48 participantsStarted 2002-09
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin with capecitabine in treating patients who have advanced esophageal cancer or stomach cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia for which no potentially curative or significant palliative therapy exists
* Unresectable disease
* Gastric cardia is defined as no more than 5 cm from the gastroesophageal junction into the stomach
* Measurable disease
* No known CNS metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* At least 12 weeks
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than upper limit of normal (ULN)
* AST no greater than 3 times ULN
* Alkaline phosphatase no greater than 2 times ULN
Renal:
* Creatinine no greater than 1.5 times ULN
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No New York Heart Association class III or IV heart disease
Other:
* Able to swallow capecitabine
* No unresolved gastrointestinal bleeding
* No uncontrolled infection
* No chronic debilitating disease
* No peripheral neuropathy grade 2 or greater
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinoma
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior immunotherapy or biological therapy for re…