Back to resultsNeoadjuvant Colorectal Cancer With Unresectable Liver Metastases
Primary Purpose
Colorectal Neoplasms, Liver Neoplasms
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Combination therapy of irinotecan with 5-FU, leucovorin plus bevacizumab in the neoadjuvant setting.
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasms
Eligibility Criteria
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
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
To determine the rate of R0 resection or pathologically confirmed CR in patients with hepatic only metastases
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00106054
Brief Title
Neoadjuvant Colorectal Cancer With Unresectable Liver Metastases
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Terminated
Why Stopped
After 1 year only 2 subjects enrolled and treated thus no meaningful efficacy analyses could be performed.
Study Start Date
January 2006 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Liver Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Combination therapy of irinotecan with 5-FU, leucovorin plus bevacizumab in the neoadjuvant setting.
Primary Outcome Measure Information:
Title
To determine the rate of R0 resection or pathologically confirmed CR in patients with hepatic only metastases
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5961065&StudyName=Neoadjuvant+Colorectal+Cancer+with+Unresectable+Liver+Metastases%2E
Description
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Learn more about this trial
Neoadjuvant Colorectal Cancer With Unresectable Liver Metastases
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