Phase I Study of Capecitabine in Combination With Cisplatin and Irinotecan

Cancer Clinical Trial

Official title:

Phase I Study Of Capecitabine in Combination With Cisplatin and Irinotecan in Patients With Advanced Malignancies.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00249977
• Other study ID #: 0103C
• Status: Completed
• Phase: Phase 1
• First received: November 2, 2005
• Last updated: January 6, 2010
• Start date: April 2003
• Est. completion date: January 2009

Study information

• Verified date: October 2009
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 2009
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Solid Tumors

Intervention

Drug:
• Capecitabine in Combination with Cisplatin and Irinotecan
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.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To study the biologic effect of pyrimidine inhibition on DNA repair after camptothecin therapy.		disease progression, unacceptable toxicities	Yes