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

Purpose

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.

Condition	Intervention	Phase
Solid Tumor	Drug: Capecitabine Drug: 5-Fluorouracil (5-FU) Drug: Irinotecan Drug: Cisplatin	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Fluorouracil Cisplatin Irinotecan Irinotecan hydrochloride Capecitabine

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To make a preliminary assessment of the anti-tumor activity of these combinations. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	68
Study Start Date:	November 2001
Estimated Study Completion Date:	January 2013
Primary Completion Date:	September 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group A Oral capecitabine	Drug: Capecitabine Orally twice a day for 14 days (dosage will vary) Drug: Irinotecan Intravenously weekly for 2 weeks (given after cisplatin) followed by a one-week rest period Drug: Cisplatin Intravenously weekly for 2 weeks followed by a one week rest period
Experimental: Group B 5-fluorouracil	Drug: 5-Fluorouracil (5-FU) Continuous infusion 24 hours a day for 14 days (Days 1-14) Dosage will vary Drug: Irinotecan Intravenously weekly for 2 weeks (given after cisplatin) followed by a one-week rest period Drug: Cisplatin Intravenously weekly for 2 weeks followed by a one week rest period

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00215501

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Massachusetts General Hospital

Investigators

Principal Investigator:

Peter C. Enzinger, MD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Peter C. Enzinger, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00215501 History of Changes
Other Study ID Numbers:	01-042
Study First Received:	September 14, 2005
Last Updated:	November 30, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

advanced solid tumor malignancy
capecitabine
continuous infusion
5-FU

irinotecan
5-fluorouracil
cisplatin

Additional relevant MeSH terms:

Neoplasms
Irinotecan
Capecitabine
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013