Neoadjuvant Colorectal Cancer With Unresectable Liver Metastases

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00106054
• Other study ID #: A5961065
• Status: Terminated
• Phase: Phase 2
• First received: March 18, 2005
• Last updated: August 26, 2010
• Start date: January 2006
• Est. completion date: September 2006

Study information

• Verified date: August 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Liver Neoplasms
• Neoplasms

Intervention

Drug:
• Combination therapy of irinotecan with 5-FU, leucovorin plus bevacizumab in the neoadjuvant setting.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the rate of R0 resection or pathologically confirmed CR in patients with hepatic only metastases
Secondary	oTo determine the resectable rate, defined as the number of subjects with R0 resection, pathologically staged CR, or undergoing non-surgical ablative procedures with curative intent divided by the total number of evaluable subjects following treatment

External Links

•   To obtain contact information for a study center near you, click here.