Neoadjuvant FOLFOX Plus Bevacizumab Chemotherapy in Patients With Locally Advanced Colon Cancer
The purpose of this study is to see if giving chemo-therapy for colon cancer before surgery can shrink the cancer and lead to a higher rate of cure than operating first and then giving chemotherapy. Standard treatment for colon cancer is to first operate, and then, if the tumor is advanced, give chemotherapy for about 6 months. However, surgery delays the time until chemotherapy can start, since the body needs time to heal from the operation. During this time any cancer cells that remain in the body that were not removed by the operation may be allowed to grow. Giving chemotherapy first could attack the cancer cells right from the start, not only at the tumor site that we know of, but also at the site of any cancer cells that may have spread to other parts of the body. Another possible reason why giving chemo therapy first might work better is that the blood vessels that feed the cancer cells are intact before surgery and thus chemotherapy can travel directly to the cancer.
This study will also use the drug bevacizumab, in addition to the standard chemotherapy. Bevacizumab has been on the market since 2004 for colon cancer that has spread to other organs, but its use in earlier stage colon cancer, as planned in this trial, is still under study.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Neoadjuvant FOLFOX Plus Bevacizumab Chemotherapy in Patients With Locally Advanced Colon Cancer|
- To determine the pathologic complete response (path CR) rate in patients with locally advanced (stage II or III) colon cancer to FOLFOX-bevacizumab administered as neoadjuvant. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- To determine the dose-limiting and non-dose-limiting toxicity rate of this regimen in the neoadjuvant setting. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- To determine the proportion of patients who are alive and recurrence free at 3 years post resection. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- To assess the feasibility of using neoadjuvant systemic chemotherapy in this study population. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- To collect tumor biopsy specimens pre- and post-neoadjuvant chemotherapy, and blood specimens pre-treatment, to determine, in an exploratory manner, molecular correlates of response to FOLFOX-bevacizumab neoadjuvant therapy. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Experimental: Neoadjuvant FOLFOX Plus Bevacizumab
FOLFOX and bevacizumab will be given to colon cancer patients for 4 cycles over 8 weeks; an additional 2 cycles of FOLFOX without bevacizumab will be given for a total of 12 weeks of pre-operative chemotherapy.Restaging will be performed within 3 weeks of the 6th chemotherapy cycle. Colon surgery will be performed between weeks 3 and 6 subsequent to the 6th cycle of FOLFOX. Patients receiving preoperative chemotherapy without radiation will wait a minimum of 3 weeks from their last dose of chemotherapy, and 6 weeks from their last dose of bevacizumab, before proceeding to surgery. Specifically, it is intended that patients will undergo surgery between 3-6 weeks from completion of their neoadjuvant therapy as deemed clinically appropriate by their surgeon and medical oncologist. This permits a 7-10 week interval between the 4th bevacizumab administration and colon surgery.
Drug: FOLFOX and bevacizumab
The patient will receive six treatments, two weeks apart. On each treatment day you will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments you will also get Bevacizumab (Avastin). These drugs are given through a Mediport. They will be given in an outpatient chemotherapy unit. Each tx will take about 4 hours. A pump for the 5-FU is worn around your waist. This drug is given over 2 days. Part II: Colon Cancer Surgery is standard practice, and is not a research procedure.Part III: Post-operative Re-Evaluation and Recovery The doctor will decide on the type of chemotherapy based on how the patient responded to the first chemotherapy. The plan will be for the patient to get 6 more doses of FOLFOX, without any further bevacizumab, unless your doctor finds a reason to do otherwise.
|United States, New Jersey|
|Memorial Sloan-Kettering at Basking Ridge|
|Basking Ridge, New Jersey, United States, 07920|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center @ Suffolk|
|Commack, New York, United States, 11725|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Memorial Sloan-Kettering Cancer Center at Mercy Medical Center|
|Rockville Centre, New York, United States, 11570|
|Memoral Sloan Kettering Cancer Center@Phelps|
|Sleepy Hollow, New York, United States|
|Principal Investigator:||Leonard Saltz, MD||Memorial Sloan-Kettering Cancer Center|