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

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ClinicalTrials.gov Identifier: NCT00065117
Recruitment Status : Terminated
First Posted : July 18, 2003
Last Update Posted : January 26, 2011
Sponsor:
Information provided by:
AstraZeneca

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 Type : Interventional  (Clinical Trial)
Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : September 2003
Actual Primary Completion Date : February 2004
Actual Study Completion Date : February 2004

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00065117


Locations
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
AstraZeneca

ClinicalTrials.gov Identifier: NCT00065117     History of Changes
Other Study ID Numbers: D2820C00007
6126IL/00007
First Posted: July 18, 2003    Key Record Dates
Last Update Posted: January 26, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
metastatic
colorectal
first-line
adjuvant
cancer
Colorectal Cancer
Colorectal Carcinoma
Colorectal Tumors
Neoplasms, Colorectal

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