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Tezacitabine and Oxaliplatin for the Treatment of Patients With Metastatic Colorectal Cancer

Primary Purpose

Colorectal Neoplasms

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
tezacitabine
oxaliplatin
Sponsored by
Chiron Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Patients with metastatic colorectal adenocarcinoma who have failed one prior course of chemotherapy. Patients must have at least one measurable tumor. Patients may not have received prior treatment with oxaliplatin.

Sites / Locations

  • ACRC/Arizona Clinical Research Center
  • USC/Norris Comprehensive Cancer Center
  • Comprehensive Cancer Centers of the Desert
  • Cancer Institute Medical Group
  • Georgetown University Medical Center, Lombardi Cancer Center
  • H. Lee Moffitt Cancer Center & Research Institute
  • Northwestern University Feinberg School of Medicine
  • Kansas City Oncology and Hematology Group

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 15, 2003
Last Updated
July 10, 2006
Sponsor
Chiron Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00051688
Brief Title
Tezacitabine and Oxaliplatin for the Treatment of Patients With Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Terminated
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Chiron Corporation

4. Oversight

5. Study Description

Brief Summary
The primary purpose of this study is to determine the best dose of tezacitabine when combined with oxaliplatin in patients with metastatic colorectal cancer. This study will also evaluate tumor response to the combination of anti-cancer drugs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
tezacitabine
Intervention Type
Drug
Intervention Name(s)
oxaliplatin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients with metastatic colorectal adenocarcinoma who have failed one prior course of chemotherapy. Patients must have at least one measurable tumor. Patients may not have received prior treatment with oxaliplatin.
Facility Information:
Facility Name
ACRC/Arizona Clinical Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Comprehensive Cancer Centers of the Desert
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Cancer Institute Medical Group
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Georgetown University Medical Center, Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
H. Lee Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Kansas City Oncology and Hematology Group
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Tezacitabine and Oxaliplatin for the Treatment of Patients With Metastatic Colorectal Cancer

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