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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Brigham and Women's Hospital

Massachusetts General Hospital

Information provided by (Responsible Party):

Peter C. Enzinger, MD, Dana-Farber Cancer Institute

ClinicalTrials.gov Identifier:

NCT00215501

First received: September 14, 2005

Last updated: November 30, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 14, 2005

Last Updated Date

November 30, 2012

Start Date ^ICMJE

November 2001

Primary Completion Date

September 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

To determine dose limiting toxicity, maximum tolerated dose and recommended Phase II dose of both capecitabine and 5-fluorouracil in this patient population.

Change History

Complete list of historical versions of study NCT00215501 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

To make a preliminary assessment of the anti-tumor activity of these combinations.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Solid Tumor

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Group A
Oral capecitabine
Interventions:
- Drug: Capecitabine
- Drug: Irinotecan
- Drug: Cisplatin
Experimental: Group B
5-fluorouracil
Interventions:
- Drug: 5-Fluorouracil (5-FU)
- Drug: Irinotecan
- Drug: Cisplatin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2013

Primary Completion Date

September 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00215501

Other Study ID Numbers ^ICMJE

01-042

Has Data Monitoring Committee

Not Provided

Responsible Party

Peter C. Enzinger, MD, Dana-Farber Cancer Institute

Study Sponsor ^ICMJE

Dana-Farber Cancer Institute

Collaborators ^ICMJE

Brigham and Women's Hospital
Massachusetts General Hospital

Investigators ^ICMJE

Principal Investigator:

Peter C. Enzinger, MD

Dana-Farber Cancer Institute

Information Provided By

Dana-Farber Cancer Institute

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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