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

This study has been terminated.
Information provided by:
AstraZeneca Identifier:
First received: July 17, 2003
Last updated: January 25, 2011
Last verified: January 2011
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 Intervention Phase
Colorectal Neoplasms
Metastases, Neoplasm
Drug: ZD6126
Drug: Placebo
Drug: 5-fluorouracil
Drug: leucovorin
Drug: oxaliplatin
Phase 2

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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Estimated Enrollment: 180
Study Start Date: September 2003
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00065117

United States, California
Research Site
Los Angeles, California, United States
Research Site
San Francisco, California, United States
United States, Illinois
Research Site
Chicago, Illinois, United States
United States, Louisiana
Research Site
New Orleans, Louisiana, United States
United States, Maryland
Research Site
Baltimore, Maryland, United States
United States, Missouri
Research Site
St. Louis, Missouri, United States
United States, New York
Research Site
New York, New York, United States
United States, North Carolina
Research Site
Chapel Hill, North Carolina, United States
Research Site
Durham, North Carolina, United States
United States, Pennsylvania
Research Site
Pittsburgh, Pennsylvania, United States
Sponsors and Collaborators
  More Information Identifier: NCT00065117     History of Changes
Other Study ID Numbers: D2820C00007  6126IL/00007 
Study First Received: July 17, 2003
Last Updated: January 25, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Colorectal Cancer
Colorectal Carcinoma
Colorectal Tumors
Neoplasms, Colorectal

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Rectal Diseases
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 30, 2016