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Neoadjuvant Colorectal Cancer With Unresectable Liver Metastases

This study has been terminated.
(After 1 year only 2 subjects enrolled and treated thus no meaningful efficacy analyses could be performed.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00106054
First received: March 18, 2005
Last updated: August 26, 2010
Last verified: August 2010
History of Changes

March 18, 2005
August 26, 2010
January 2006
September 2006   (final data collection date for primary outcome measure)
To determine the rate of R0 resection or pathologically confirmed CR in patients with hepatic only metastases
To determine the rate of R0 resection or pathologically confirmed CR in patients with hepatic only metastases
Complete list of historical versions of study NCT00106054 on ClinicalTrials.gov Archive Site
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
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 wi
 
 
 
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

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.
 
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Colorectal Neoplasms
  • Liver Neoplasms
Drug: Combination therapy of irinotecan with 5-FU, leucovorin plus bevacizumab in the neoadjuvant setting.
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
September 2006
September 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00106054
A5961065
 
 
Pfizer
 
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP