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.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00065117
First received: July 17, 2003
Last updated: January 25, 2011
Last verified: January 2011
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Purpose
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:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
More Information
No publications provided
| ClinicalTrials.gov 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:
|
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 Fluorouracil |
Oxaliplatin Leucovorin Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients |
ClinicalTrials.gov processed this record on May 23, 2013