Safety, Tolerability and Efficacy of ZD6126 in Combination With Oxaliplatin, 5-Fluorouracil and Leucovorin in Subjects With Metastatic Colorectal Cancer.

Sponsor

AstraZeneca (Industry)

Overall Status

Terminated

CT.gov ID

NCT00065117

Collaborator

(none)

180

Enrollment

Locations

Duration (Months)

Patients Per Site

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the Safety, Tolerability and Efficacy of ZD6126 in Combination with Oxaliplatin, 5-Fluorouracil and Leucovorin in Subjects with Metastatic Colorectal Cancer.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Neoplasms Metastases, Neoplasm	Drug: ZD6126 Drug: Placebo Drug: 5-fluorouracil Drug: leucovorin Drug: oxaliplatin	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Study Start Date :

Sep 1, 2003

Actual Primary Completion Date :

Feb 1, 2004

Actual Study Completion Date :

Feb 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Metastatic colorectal carcinoma
Suitable for first-line treatment of metastatic disease

Exclusion Criteria:

Peripheral neuropathy greater than Grade 1
Adjuvant therapy within 6 months prior to study treatment
Prior oxaliplatin
Prior pelvic or whole abdomen radiation
Any history of coronary angioplasty or history of myocardial infarction

Contacts and Locations

Locations

	Site	City	State	Country
1	Research Site	Los Angeles	California	United States
2	Research Site	San Francisco	California	United States
3	Research Site	Chicago	Illinois	United States
4	Research Site	New Orleans	Louisiana	United States
5	Research Site	Baltimore	Maryland	United States
6	Research Site	St. Louis	Missouri	United States
7	Research Site	New York	New York	United States
8	Research Site	Chapel Hill	North Carolina	United States
9	Research Site	Durham	North Carolina	United States
10	Research Site	Pittsburgh	Pennsylvania	United States