Capecitabine, Epirubicin, and Carboplatin in Treating Patients With Progressive, Unresectable, or Metastatic Cancer

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine, epirubicin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when given together with epirubicin and carboplatin in treating patients with progressive, unresectable, or metastatic cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Nebraska
• Collaborator: National Cancer Institute (NCI)
• Treatments: Capecitabine; Carboplatin; Epirubicin

Criteria

DISEASE CHARACTERISTICS:

• Pathologically confirmed cancer, meeting 1 of the following criteria:

• Disease that has progressed on standard therapy

• Locally advanced but unresectable primary or recurrent solid tumor

• Metastatic disease, including previously untreated metastatic disease for which study regimen represents reasonable initial chemotherapy with palliative intent (e.g., metastatic gastric cancer, hepatobiliary cancer, or cancer for which no effective standard therapy exists)

• No other potentially curative treatment options available (e.g., surgery, radiotherapy, chemoradiotherapy, or combination chemotherapy)

• No leukemia or lymphoma

• No primary CNS malignancies or CNS metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Absolute neutrophil count ≥ 2,000/mm³

• Platelet count ≥ 100,000/mm³

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• AST and ALT ≤ 2.5 times ULN

• Creatinine ≤ 1.6 mg/dL

• Left ventricular ejection fraction ≥ 50%

• No other medical illness that would preclude study treatment

• No active infection requiring IV antibiotic therapy unless the infection has resolved

• No history of allergy to platinum compounds, mannitol, or to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy

• No history of unexpectedly severe intolerance to fluorouracil

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Recovered from prior therapy

• No prior doxorubicin at cumulative doses > 300 mg/m²

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) or immunotherapy

• At least 2 weeks since prior radiotherapy

• At least 8 weeks since prior strontium therapy

• At least 4 weeks since prior and no concurrent sorivudine or brivudine

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No concurrent cimetidine