Status:
COMPLETED
Capecitabine or 5-Fluorouracil in Combination With Irinotecan and Cisplatin in Patients With Solid Tumor Malignancies
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Massachusetts General Hospital
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 h...
Detailed Description
* This is a Phase I dose escalation study. The dose of drug the patient receives will be assigned based upon when they enter the study. Since we are looking for the highest dose of capecitabine or 5-f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00215501
Start Date
November 1 2001
End Date
September 1 2008
Last Update
November 2 2018
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115