Efficacy and Safety of Second-line Combination Chemotherapy With Avastin in Patients With Metastatic Colorectal Cancer Who Have Received First-line Chemotherapy Plus Avastin
18 Years
N/A
Both
Metastatic Colorectal Cancer
Trial Information
Efficacy and Safety of Second-line Combination Chemotherapy With Avastin in Patients With Metastatic Colorectal Cancer Who Have Received First-line Chemotherapy Plus Avastin
Patients should have been treated with bevacizumab plus chemotherapy as a 1st line
treatment, and after 1st progression, these patients will be accrued in this study of
bevacizumab plus chemotherapy as a 2nd line treatment, and the combined chemotherapy will be
chosen by physician's decision in consider with previous chemotherapy.
Inclusion Criteria:
- Histologically documented colorectal adenocarcinoma
- Progression during first-line bevacizumab containing chemotherapy within 3 months
- No serious toxicity to bevacizumab of 1st line treatment
- Unresectable metastases
- Uni-dimensional measurable lesion(s) by RECIST
- Age over 18 years old
- ECOG 0-2
- Adequate organ functions by clinical laboratory exams
Exclusion Criteria:
- Other tumor type than adenocarcinoma
- CNS metastases
- GI bleeding
- Hypersensitivity to any of chemotherapeutic agents
- Prior use of cetuximab or other targeted agents other than bevacizumab
- Major surgery within 6 weeks
- Other serious illness
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression free survival
Outcome Time Frame:
6 weeks
Safety Issue:
Yes
Principal Investigator
Tae Won Kim, M.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Asan Medical Center
Authority:
South Korea: Institutional Review Board
Study ID:
AMC-2008-0487
NCT ID:
NCT00862342
Start Date:
January 2009
Completion Date:
June 2012
Related Keywords:
- Metastatic Colorectal Cancer
- colorectal cancer
- Bevacizumab
- Colorectal Neoplasms
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