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