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

NCT ID: NCT00215501

Last Updated: 2018-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-11-30
• Study Completion Date: 2008-09-30

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 have on patients with unresectable, advanced solid tumors.

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-fluorouracil that can be given safely in combination with cisplatin and irinotecan, not everyone who participates in this study will be receiving the same amount of the drug.
• There are four parts to this study: 1)Choice of treatment, 2)Evaluation, 3)Chemotherapy and 4)Follow-up.
• The patient and the patient's doctor will decide which form of chemotherapy is best for the patient, either pill form or continuous infusion. Chemotherapy pills (capecitabine) are given twice per day for 14 days is a row every 3 weeks. Continuous infusion (5-fluorouracil) is given through a pump 24 hours a day for 14 days every 3 weeks.
• Prior to initiation to therapy the extent of the patients cancer will be evaluated. This includes a CT scan, chest x-ray, EKG and bloodwork.
• Patient's will receive chemotherapy for 2 weeks followed by a one week break. This will constitute one cycle. The medications cisplatin and irinotecan will be given intravenously on the 1st and 8th day of each cycle. Following the rest period the next cycle of chemotherapy begins.
• Following 2 cycles of chemotherapy, the patients cancer will be re-evaluated. A CT scan and bloodwork will be obtained and will be compared to the previous studies. Treatment will resume if the cancer is the same size or smaller than before and the patient is tolerating the chemotherapy well. The cancer will be re-evaluated every 2 cycles of chemotherapy.

Conditions

Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

Oral capecitabine

Group Type: EXPERIMENTAL

Capecitabine

Intervention Type: DRUG

Orally twice a day for 14 days (dosage will vary)

Irinotecan

Intervention Type: DRUG

Intravenously weekly for 2 weeks (given after cisplatin) followed by a one-week rest period

Cisplatin

Intervention Type: DRUG

Intravenously weekly for 2 weeks followed by a one week rest period

Group B

5-fluorouracil

Group Type: EXPERIMENTAL

5-Fluorouracil (5-FU)

Intervention Type: DRUG

Continuous infusion 24 hours a day for 14 days (Days 1-14) Dosage will vary

Irinotecan

Intervention Type: DRUG

Intravenously weekly for 2 weeks (given after cisplatin) followed by a one-week rest period

Cisplatin

Intervention Type: DRUG

Intravenously weekly for 2 weeks followed by a one week rest period

Interventions

Capecitabine

Orally twice a day for 14 days (dosage will vary)

Intervention Type: DRUG

5-Fluorouracil (5-FU)

Continuous infusion 24 hours a day for 14 days (Days 1-14) Dosage will vary

Intervention Type: DRUG

Irinotecan

Intravenously weekly for 2 weeks (given after cisplatin) followed by a one-week rest period

Intervention Type: DRUG

Cisplatin

Intravenously weekly for 2 weeks followed by a one week rest period

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Peter C. Enzinger, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter C. Enzinger, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

01-042

Identifier Type: -

Identifier Source: org_study_id