NCT00051688

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2003

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2003

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
Last Updated

July 11, 2006

Status Verified

July 1, 2006

First QC Date

January 15, 2003

Last Update Submit

July 10, 2006

Conditions

Colorectal Neoplasms

Interventions

tezacitabineDRUG
oxaliplatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (8)

ACRC/Arizona Clinical Research Center

Tucson, Arizona, 85712, United States

Location

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Comprehensive Cancer Centers of the Desert

Palm Springs, California, 92262, United States

Location

Cancer Institute Medical Group

Santa Monica, California, 90404, United States

Location

Georgetown University Medical Center, Lombardi Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612-9497, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Kansas City Oncology and Hematology Group

Kansas City, Missouri, 64111, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

tezacitabineOxaliplatin

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 15, 2003

First Posted

January 16, 2003

Study Start

June 1, 2003

Study Completion

August 1, 2004

Last Updated

July 11, 2006

Record last verified: 2006-07

Locations

US(8)