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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center Genentech |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00826800 |
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.
Condition | Intervention |
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Colon Cancer |
Drug: FOLFOX and bevacizumab |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Study of Neoadjuvant FOLFOX Plus Bevacizumab Chemotherapy in Patients With Locally Advanced Colon Cancer |
Estimated Enrollment: | 31 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | January 2013 |
Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Neoadjuvant FOLFOX Plus Bevacizumab: Experimental
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. |
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Leonard Saltz, MD | 212-639-2501 | |
Contact: Martin Weiser, MD | 212-639-6698 |
United States, New Jersey | |
Memorial Sloan-Kettering at Basking Ridge | Recruiting |
Basking Ridge, New Jersey, United States, 07920 | |
Contact: Leonard Saltz, MD | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Leonard Saltz, MD 212-639-2501 | |
Contact: Martin Weiser, MD 212-639-6698 | |
Principal Investigator: Leonard Saltz, MD | |
Memoral Sloan Kettering Cancer Center@Phelps | Recruiting |
Sleepy Hollow, New York, United States | |
Contact: Leonard Saltz, MD | |
Memorial Sloan-Kettering Cancer Center @ Suffolk | Recruiting |
Commack, New York, United States, 11725 | |
Contact: Leonard Saltz, MD | |
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center | Recruiting |
Rockville Centre, New York, United States, 11570 | |
Contact: Leonard Saltz, MD |
Principal Investigator: | Leonard Saltz, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Leonard Saltz, MD ) |
Study ID Numbers: | 08-162 |
Study First Received: | January 20, 2009 |
Last Updated: | July 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00826800 History of Changes |
Health Authority: | United States: Institutional Review Board |
BEVACIZUMAB (AVASTIN) FLUOROURACIL LEUCOVORIN OXALIPLATIN Chemotherapy |
Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Leucovorin Bevacizumab Folinic Acid Intestinal Diseases Angiogenesis Inhibitors |
Intestinal Neoplasms Oxaliplatin Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Colonic Neoplasms Colorectal Neoplasms |
Digestive System Neoplasms Antineoplastic Agents Gastrointestinal Diseases Growth Substances Physiological Effects of Drugs Colonic Diseases Bevacizumab Intestinal Diseases Angiogenesis Inhibitors Pharmacologic Actions |
Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Growth Inhibitors Angiogenesis Modulating Agents Colonic Neoplasms Colorectal Neoplasms |