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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
Not Enrolling
Both
Colorectal Neoplasms, Liver Neoplasms

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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 SiteBronx, New York  10461
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535