Phase I Study of Capecitabine in Combination With Cisplatin and Irinotecan - Full Text View

Sponsored by:	University of New Mexico
Information provided by:	University of New Mexico
ClinicalTrials.gov Identifier:	NCT00249977

Purpose

To determine the safety and feasibility of administering Capecitabine with the combination of Cisplatin and Irinotecan.
To determine the Phase II recommended dose and toxicity profile of Capecitabine with the combination of Cisplatin and Irinotecan.
To study the biologic effect of pyrimidine inhibition on DNA repair after camptothecin therapy.

Condition	Intervention	Phase
Solid Tumors Cancer	Drug: Capecitabine in Combination with Cisplatin and Irinotecan	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Cisplatin Irinotecan Irinotecan hydrochloride Capecitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Phase I Study Of Capecitabine in Combination With Cisplatin and Irinotecan in Patients With Advanced Malignancies.

Further study details as provided by University of New Mexico:

Primary Outcome Measures:

To determine the safety/feasibility of Capecitabine with the combination of Cisplatin and Irinotecan. To determine the Phase II recommended dose and toxicity profile of Capecitabine with the combination of Cisplatin and Irinotecan. [ Time Frame: Progressing disease or unacceptable toxicities ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To study the biologic effect of pyrimidine inhibition on DNA repair after camptothecin therapy. [ Time Frame: disease progression, unacceptable toxicities ] [ Designated as safety issue: Yes ]

Enrollment:	21
Study Start Date:	April 2003
Estimated Study Completion Date:	May 2008
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Cisplatin 50 mg/m2 on day 1 (course 1) or day 11 (subsequent courses) Irinotecan 50 mg/m2 on day 1, 8, and 15 (course 1) or day 11, 18 and 25 (subsequent courses).

Capecitabine will be administered from day 1 to day 10 PO starting on course 2.

Detailed Description:

RATIONALE: Many studies have tested the combination of cisplatin and irinotecan. Side effects have been well described. The two drugs are synergistic.

The standard of care for colon cancer is the combination of 5-FU, leucovorin and irinotecan (Saltz regimen). Recently, oxaliplatin has been introduced for the treatment of colon cancer. Combination of oxaliplatin with 5FU (Folfox4) have shown comparable activity to the Saltz regimen. Furthermore, one author recently published on the triple combination of oxaliplatin, 5FU and irinotecan, with impressive clinical activity in colon cancer.

There is some evidence that 5FU impairs DNA repair. One of the putative resistance mechanism to topoisomerase I inhibitors is increased DNA repair. We therefore hypothesize that inhibition of DNA repair by capecitabine may increase the activity of the combination of cisplatin and irinotecan.

This study is open to all patients with solid tumor who have failed a line of chemotherapy

Eligibility

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

Criteria

Inclusion Criteria:

All patients, 18 years of age or older, with incurable advanced cancer for whom there is no effective therapy are eligible.
Patients must have a life expectancy of at least 12 weeks.
Patients must have a Zubrod performance status of 0-2.
Patients must sign an informed consent.
Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of > 1,500 or cells/mm3 and platelet count >100,000/mm3 and absence of a regular red blood cell transfusion requirement.
Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and SGOT or SGPT < two times the upper limit of normal, and adequate renal function as defined by a serum creatinine < 1.5 x upper limit of normal.

Exclusion Criteria:

Patients with symptomatic brain metastases are excluded from this study.
Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
Patients whose cancer progressed while receiving 5-FU, cisplatin or irinotecan.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00249977

Locations

United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131

Sponsors and Collaborators

University of New Mexico

Investigators

Principal Investigator:

Claire F Verschraegen, MD

University of New Mexico

More Information

Responsible Party:	University of New Mexio - CRTC ( Claire Verschraegen, M.D.; Principal Investigator )
Study ID Numbers:	0103C
Study First Received:	November 2, 2005
Last Updated:	March 24, 2008
ClinicalTrials.gov Identifier:	NCT00249977
Health Authority:	United States: Institutional Review Board

Keywords provided by University of New Mexico:

Phase I
solid tumors
DNA repair

Study placed in the following topic categories:

Capecitabine
Cisplatin
Irinotecan

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009