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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors, Cancer

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Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

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

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.

Outcome Time Frame:

Progressing disease or unacceptable toxicities

Safety Issue:

Yes

Principal Investigator

Claire F Verschraegen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico

Authority:

United States: Institutional Review Board

Study ID:

0103C

NCT ID:

NCT00249977

Start Date:

April 2003

Completion Date:

January 2009

Related Keywords:

  • Solid Tumors
  • Cancer
  • Phase I
  • solid tumors
  • DNA repair

Name

Location
University of New Mexico Albuquerque, New Mexico  87131