An Open-Label, Multi-Center Phase II Trial of Neoadjuvant Irinotecan in Combination With Infusional 5-FU, Leucovorin (Folfiri) Plus Bevacizumab in Patients With Unresectable Hepatic-Only Metastases of Colorectal Carcinoma
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Neoplasms, Liver Neoplasms
Both
Colorectal Neoplasms, Liver Neoplasms
Trial Information
An Open-Label, Multi-Center Phase II Trial of Neoadjuvant Irinotecan in Combination With Infusional 5-FU, Leucovorin (Folfiri) Plus Bevacizumab in Patients With Unresectable Hepatic-Only Metastases of Colorectal Carcinoma
Inclusion Criteria:
- ECOG performance status of 0 or 1
- Histological documentation of adenocarcinoma of the colon or rectum. The primary
site must have been confirmed to be in the large bowel
Exclusion Criteria:
- Prior systemic anticancer therapy for mCRC
- Prior hepatic surgery, chemoembolization, hepatic artery infusion, radiofrequency
ablation or cryotherapy for liver metastases
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the rate of R0 resection or pathologically confirmed CR in patients with hepatic only metastases
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A5961065
NCT ID:
NCT00106054
Start Date:
January 2006
Completion Date:
September 2006
Related Keywords:
- Colorectal Neoplasms
- Liver Neoplasms
- Neoplasms
- Colorectal Neoplasms
- Liver Neoplasms
- Neoplasm Metastasis
Name | Location |
|---|---|
| Pfizer Investigational Site | Bronx, New York 10461 |
| Pfizer Investigational Site | Kingston, Pennsylvania 18704-5535 |
