NCT00106054

Neoadjuvant Colorectal Cancer With Unresectable Liver Metastases

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study was terminated early due to low enrollment with only 2 subjects enrolled and treated after being open for enrollment for over a year. Therefore, no meaningful efficacy analyses could be performed. This trial is studying the effects (good and bad) of a combination of drugs, Irinotecan in combination with infusional 5-FU, leucovorin (FOLFIFI) plus Bevacizumab, for cancer of the colon or rectum that has spread to the liver only and is currently not able to be removed by surgery. All of the drugs that will be received in this research study have been approved in the United States for colorectal cancer, that has spread to other areas of the body, including the liver. Another reason for doing this study is to see if the chemotherapy drugs FOLFIFI plus Bevacizumab can sufficiently decrease the size of the cancer in the liver so that any tumor remaining can be completely removed with surgery and, if it can be removed whether doing so will prolong the time it takes the cancer to return and/or prolong the life of these patients. This trial is also looking at the genes of people who take part in this study, to see if it is possible to find out characteristics that can help predict whose cancer will respond well or not so well, and who will have more or less side effects to this chemotherapy.

Conditions

• Colorectal Neoplasms
• Liver Neoplasms

Interventions

Type	Name	Description
DRUG	Combination therapy of irinotecan with 5-FU, leucovorin plus bevacizumab in the neoadjuvant setting.

Timeline

• Start date: 2006-01-01
• Primary completion: 2006-09-01
• Completion: 2006-09-01
• First posted: 2005-03-21
• Last updated: 2010-08-27

Locations

2 sites across 1 country: United States