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NCT00065117 Clinical Trial

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

Colorectal Neoplasms Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00065117
Other study ID # D2820C00007
Secondary ID 6126IL/00007
Status Terminated
Phase Phase 2
First received July 17, 2003
Last updated January 25, 2011
Start date September 2003
Est. completion date February 2004

Study information
Verified date January 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 180
Est. completion date February 2004
Est. primary completion date February 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ZD6126

• Placebo

• 5-fluorouracil

• leucovorin

• oxaliplatin

Locations
Country Name City State
United States Research Site Baltimore Maryland
United States Research Site Chapel Hill North Carolina
United States Research Site Chicago Illinois
United States Research Site Durham North Carolina
United States Research Site Los Angeles California
United States Research Site New Orleans Louisiana
United States Research Site New York New York
United States Research Site Pittsburgh Pennsylvania
United States Research Site San Francisco California
United States Research Site St. Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

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