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

November 2, 2005
January 6, 2010
April 2003
August 2007   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00249977 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
Not Provided
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Phase I Study of Capecitabine in Combination With Cisplatin and Irinotecan
Phase I Study Of Capecitabine in Combination With Cisplatin and Irinotecan in Patients With Advanced Malignancies.
  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.

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

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Solid Tumors
  • Cancer
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.

Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
January 2009
August 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00249977
0103C
Yes
Claire Verschraegen, M.D.; Principal Investigator, University of New Mexio - CRTC
University of New Mexico
Not Provided
Principal Investigator: Claire F Verschraegen, MD University of New Mexico
University of New Mexico
October 2009

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