Phase I Study of Capecitabine in Combination With Cisplatin and Irinotecan

Phase 1

Completed

• Conditions: Solid Tumors; Cancer

• Registration Number: NCT00249977
• Lead Sponsor: University of New Mexico

Brief Summary

1. To determine the safety and feasibility of administering Capecitabine with the combination of Cisplatin and Irinotecan.

2. To determine the Phase II recommended dose and toxicity profile of Capecitabine with the combination of Cisplatin and Irinotecan.

3. To study the biologic effect of pyrimidine inhibition on DNA repair after camptothecin therapy.

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

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2005-11-02
• Study First Submitted QC: 2005-11-03
• Study First Posted: 2005-11-07
• Primary Completion: 2007-08
• Study Completion: 2009-01
• Status Verified: 2009-10
• Last Update Submitted: 2010-01-06
• Last Update Posted: 2010-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	Progressing disease or unacceptable toxicities

Secondary Outcome Measures

Name	Time	Method
To study the biologic effect of pyrimidine inhibition on DNA repair after camptothecin therapy.	disease progression, unacceptable toxicities

Trial Locations

Locations (1)

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States