Capecitabine Combined With Cisplatin in Treating Patients With Locally Advanced or Metastatic Solid Tumors

Launched by NYU LANGONE HEALTH · Jan 26, 2003

Keywords

ClinConnect Summary

OBJECTIVES:

* Determine the dose-limiting toxicity, maximum tolerated dose, and the recommended phase II dose of capecitabine and cisplatin in patients with locally advanced or metastatic cancer of the upper gastrointestinal tract (GI), head and neck, lung, breast, or carcinoma of unknown primary.
* Determine the toxic effects of this regimen in these patients.
* Evaluate possible antitumor effectiveness of this regimen in these patients.
* Determine the toxic effects of cisplatin and capecitabine at the recommended phase II dose in patients with cancer of the upper GI tract.
* Determine t...

Gender

ALL

Eligibility criteria

• 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 fluorouracil or cisplatin
• • At least 3 weeks since other prior chemotherapy
• Endocrine therapy:
• • Not specified
• Radiotherapy:
• • At least 3 weeks since prior radiotherapy
• Surgery:
• • See Disease Characteristics