Capecitabine Combined With Cisplatin in Treating Patients With Locally Advanced or Metastatic Sol… (NCT00010023) | Clinical Trial Compass
CompletedPhase 1
Capecitabine Combined With Cisplatin in Treating Patients With Locally Advanced or Metastatic Solid Tumors
United StatesStarted 2000-08
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 chemotherapy drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of capecitabine combined with cisplatin in treating patients who have locally advanced or metastatic solid tumors .
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 confirmed metastatic or locally advanced inoperable carcinoma of the upper gastrointestinal tract, head and neck, lung, breast, or carcinoma of unknown primary
* Previously treated and/or resected primary tumors allowed
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Sex:
* Not specified
Menopausal status:
* Not specified
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 less than 2 mg/dL\*
* AST less than 3 times upper limit of normal (ULN)\*
* Alkaline phosphatase no greater than 3 times ULN\* NOTE: \* Unless related to tumor (e.g., cholangiocarcinoma or hepatic metastases)
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance greater than 60 mL/min
* BUN no greater than 30 mg/dL\* NOTE: \* Unless related to tumor (e.g., cholangiocarcinoma or hepatic metastases)
Other:
* No other medical condition that could interfere with oral medication absorption
* No prior or concurrent malignancy except surgically cured carcinoma of the cervix or basal cell or squamous cell carcinoma skin cancer
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* At least 6 months since prior fluo…