A Phase I,Open Label Study to Assess the Safety and Tolerability of ZD6474 in Combination With 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as First and Second Line Therapy in Patients With Advanced Colorectal Adenocarcinoma.
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Advanced Colorectal Carcinoma
Both
Advanced Colorectal Carcinoma
Trial Information
A Phase I,Open Label Study to Assess the Safety and Tolerability of ZD6474 in Combination With 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as First and Second Line Therapy in Patients With Advanced Colorectal Adenocarcinoma.
Inclusion Criteria:
1. Histologically confirmed locally advanced, recurrent or metastatic colorectal
adenocarcinoma (Stage IV)
2. WHO performance status 0-1
3. one or more measurable lesions min 10mm by spiral CT or min 20mm by conventional
techniques
Exclusion Criteria:
1. Brain metastasis or spinal cord compression unless irradiated at least 4 weeks before
entry and stable
2. last dose of prior chemotherapy discontinued at least 4 weeks before start study
treatment
3. prior unanticipated severe reaction to oxaliplatin
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin
Outcome Time Frame:
Assessed at each visit
Safety Issue:
No
Principal Investigator
Michael Michael, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
AstraZeneca
Authority:
Australia: Department of Health and Ageing Therapeutic Goods Administration
Study ID:
D4200C00037
NCT ID:
NCT00499850
Start Date:
August 2005
Completion Date:
April 2008
Related Keywords:
- Advanced Colorectal Carcinoma
- ZD6474
- FOLFOX
- colorectal
- adenocarcinoma
- Adenocarcinoma
- Carcinoma
- Colorectal Neoplasms
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