Phase I Study of Capecitabine in Combination With Cisplatin and Irinotecan

NCT00249977 | Completed Phase 1 DMC

• 1 other identifier: 0103C
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To determine the safety and feasibility of administering Capecitabine with the combination of Cisplatin and Irinotecan.
2. 2.To determine the Phase II recommended dose and toxicity profile of Capecitabine with the combination of Cisplatin and Irinotecan.
3. 3.To study the biologic effect of pyrimidine inhibition on DNA repair after camptothecin therapy.

Conditions

Solid Tumors; Cancer

Keywords

Phase I; solid tumors; DNA repair

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  disease progression, unacceptable toxicities

Interventions

Capecitabine in Combination with Cisplatin and Irinotecan DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Capecitabine; Cisplatin; Irinotecan

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Camptothecin; Alkaloids

Study Officials

• Claire F Verschraegen, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 2, 2005
• First Posted: November 7, 2005
• Study Start: April 1, 2003
• Primary Completion: August 1, 2007
• Study Completion: January 1, 2009
• Last Updated: January 7, 2010

Record last verified: 2009-10

Locations

US (1)