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
  Purpose

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.


Condition Intervention Phase
Colorectal Neoplasms
Liver Neoplasms
Drug: Combination therapy of irinotecan with 5-FU, leucovorin plus bevacizumab in the neoadjuvant setting.
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

Enrollment: 2
Study Start Date: January 2006
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106054

Locations
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10029
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00106054     History of Changes
Other Study ID Numbers: A5961065
Study First Received: March 18, 2005
Last Updated: August 26, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Liver Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Liver Diseases
Neoplastic Processes
Pathologic Processes
Leucovorin
Bevacizumab
Levoleucovorin
Irinotecan
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antidotes
Protective Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 22, 2014