Status:
TERMINATED
Irinotecan Discontinuation and Reintroduction for Advanced Colorectal Cancer
Lead Sponsor:
Gachon University Gil Medical Center
Conditions:
Colorectal Neoplasms
Metastases
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the feasibility and efficacy of first-line FOLFIRI discontinuation after initial 8 cycles and reintroduction after progression.
Detailed Description
For medically-fit patients with advanced colorectal cancer, the current standard approach is chemotherapy with FOLFIRI or FOLFOX. Although a strategy of using sequential 5-FU, irinotecan and oxaliplat...
Eligibility Criteria
Inclusion
- Histologically proven adenocarcinoma of colon and rectum
- No prior chemotherapy or only adjuvant chemotherapy and/or radiotherapy
- Advanced, metastatic or recurrent not amenable to curative local therapy
- Measurable lesion(s)
- ECOG performance status 0 to 2
- Normal marrow, hepatic and renal function
- Provision of written informed consent
Exclusion
- Active infection and/or severe comorbidity
- Known history of anaphylaxis of any origin
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00320320
Start Date
April 1 2005
End Date
April 1 2007
Last Update
November 25 2008
Active Locations (1)
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1
Gachon University Gil Medical Center
Incheon, South Korea, 405 760