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

Completed · Phase 1

Conditions studied: Solid Tumor

In brief

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.

Key facts

Study ID

NCT00215501

Run by

Dana-Farber Cancer Institute

People needed

54

Starts

2001-11-01

Expected to finish

2008-09-01

Last updated by the study team

2018-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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