Phase I Study of Capecitabine in Combination With Cisplatin and Irinotecan

This study has been completed.
Sponsor:
Information provided by:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00249977
First received: November 2, 2005
Last updated: January 6, 2010
Last verified: October 2009
  Purpose
  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.

Condition Intervention Phase
Solid Tumors
Cancer
Drug: Capecitabine in Combination with Cisplatin and Irinotecan
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study Of Capecitabine in Combination With Cisplatin and Irinotecan in Patients With Advanced Malignancies.

Resource links provided by NLM:


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
Study Completion Date: January 2009
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Claire Verschraegen, M.D.; Principal Investigator, University of New Mexio - CRTC
ClinicalTrials.gov Identifier: NCT00249977     History of Changes
Other Study ID Numbers: 0103C
Study First Received: November 2, 2005
Last Updated: January 6, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of New Mexico:
Phase I
solid tumors
DNA repair

Additional relevant MeSH terms:
Irinotecan
Capecitabine
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 26, 2014