- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00215501
Capecitabine or 5-Fluorouracil in Combination With Irinotecan and Cisplatin in Patients With Solid Tumor Malignancies
October 31, 2018 updated by: Peter C. Enzinger, MD, Dana-Farber Cancer Institute
A Phase I Trial of Capecitabine or Continuous Infusion 5-Fluorouracil in Combination With Weekly Irinotecan and Cisplatin in Patients With Advanced Solid Tumor Malignancies
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
Oral capecitabine
|
Orally twice a day for 14 days (dosage will vary)
Intravenously weekly for 2 weeks (given after cisplatin) followed by a one-week rest period
Intravenously weekly for 2 weeks followed by a one week rest period
|
Experimental: Group B
5-fluorouracil
|
Intravenously weekly for 2 weeks (given after cisplatin) followed by a one-week rest period
Intravenously weekly for 2 weeks followed by a one week rest period
Continuous infusion 24 hours a day for 14 days (Days 1-14) Dosage will vary
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine dose limiting toxicity, maximum tolerated dose and recommended Phase II dose of both capecitabine and 5-fluorouracil in this patient population.
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To make a preliminary assessment of the anti-tumor activity of these combinations.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter C. Enzinger, MD, Dana-Farber Cancer Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2001
Primary Completion (Actual)
September 1, 2005
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
September 14, 2005
First Submitted That Met QC Criteria
September 14, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Actual)
November 2, 2018
Last Update Submitted That Met QC Criteria
October 31, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Cisplatin
- Fluorouracil
- Capecitabine
- Irinotecan
Other Study ID Numbers
- 01-042
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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