CompletedInterventionalPhase 2Updated Jan 25, 2018
Safety, Tolerability and Efficacy of ZD6126 in Combination With Oxaliplatin, 5-Fluorouracil and Leucovorin in Subjects With Metastatic Colorectal... | NCT00065117 | Trialant
TerminatedInterventionalPhase 2Updated Jan 26, 2011
Safety, Tolerability and Efficacy of ZD6126 in Combination With Oxaliplatin, 5-Fluorouracil and Leucovorin in Subjects With Metastatic Colorectal Cancer.
ClinicalTrials.gov ID
NCT00065117
Lead Sponsor
AstraZenecaINDUSTRY
Overall Status
Terminated
Study Type
Interventional
Phase
Phase 2
Enrollment
180
Last Update Posted
Jan 26, 2011Estimated
Start Date
Sep 2003
Primary Completion Date
Feb 2004Actual
Completion Date
Feb 2004Actual
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.
Colorectal Neoplasms
Metastases, Neoplasm
ZD6126
Placebo
5-fluorouracil
leucovorin
oxaliplatin
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
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