Capecitabine or 5-Fluorouracil in Combination With Irinotecan and Cisplatin in Patients With Solid Tumor Malignancies

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test the safety of irinotecan and cisplatin in combination with either capecitabine or continuous infusion 5-fluorouracil and to see what effects (good and bad) these have on patients with unresectable, advanced solid tumors.

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

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Brigham and Women's Hospital; Massachusetts General Hospital
• Treatments: Camptothecin; Capecitabine; Cisplatin; Fluorouracil; Irinotecan

Criteria

Inclusion Criteria:

• Histologically confirmed solid tumor malignancy

• 18 years of age or older

• Two prior chemotherapy regimens for metastatic disease. Prior chemotherapy must have been completed at least 3 weeks prior to initiation of this protocol.

• ECOG performance status of 0,1 or 2

• Neutrophils greater or equal to 1,500/ul

• Platelets greater or equal to 100,000/ul

• Serum bilirubin less or equal to 1.5 mg/dl

• Creatinine clearance greater than 50 ml/min

• AST or SGOT less or equl to 3x ULN

• Prior radiotherapy is allowable, provided at least 4 weeks have elapsed and the patient has recovered from all therapy related side effects.

Exclusion Criteria:

• Life expectancy of less than 3 months

• Clinically significant cardiac disease or myocardial infarction within past 6 months

• Suspicion or documentation of CNS metastases or carcinomatous meningitis

• Psychiatric disability judged by the investigator to be clinically significant, precluding informed consent

• Known existing coagulopathy and/or requires therapeutic anticoagulants

• Uncontrolled diarrhea

• Peripheral neuropathy

• Major surgery within 3 weeks of the state of the study treatment without complete recovery

• Serious, uncontrolled, concurrent infection

• Lack of physical integrity of upper gastrointestinal tract or malabsorption syndrome

• Prior severe reaction to fluoropyrimidine, irinotecan or cisplatin

• Known interstitial pulmonary fibrosis

• Known Gilbert's disease

• Uncontrolled diabetes mellitus

• Organ allograft(s) on immunosuppressive therapy

• Pregnant or lactating women

• Patients taking valproic acid