Back to resultsSafety, Tolerability and Efficacy of ZD6126 in Combination With Oxaliplatin, 5-Fluorouracil and Leucovorin in Subjects With Metastatic Colorectal Cancer.
Primary Purpose
Colorectal Neoplasms, Metastases, Neoplasm
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ZD6126
Placebo
5-fluorouracil
leucovorin
oxaliplatin
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasms focused on measuring metastatic, colorectal, first-line, adjuvant, cancer, Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors, Neoplasms, Colorectal
Eligibility 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
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
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Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00065117
Brief Title
Safety, Tolerability and Efficacy of ZD6126 in Combination With Oxaliplatin, 5-Fluorouracil and Leucovorin in Subjects With Metastatic Colorectal Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Terminated
Study Start Date
September 2003 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
February 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Metastases, Neoplasm
Keywords
metastatic, colorectal, first-line, adjuvant, cancer, Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors, Neoplasms, Colorectal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
180 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ZD6126
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil
Intervention Type
Drug
Intervention Name(s)
leucovorin
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Research Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
San Francisco
State/Province
California
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
Country
United States
Facility Name
Research Site
City
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety, Tolerability and Efficacy of ZD6126 in Combination With Oxaliplatin, 5-Fluorouracil and Leucovorin in Subjects With Metastatic Colorectal Cancer.
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