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A Pilot Study of Neoadjuvant FOLFOX plus Bevacizumab in Patients With Locally Advanced Colon Cancer

[Protocol 08-162]

Full Title :
A PILOT STUDY OF NEOADJUVANT FOLFOX PLUS BEVACIZUMAB CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED COLON CANCER
Purpose :

The purpose of this study is to see if giving chemotherapy for locally advanced colon cancer before surgery can shrink the cancer and lead to a higher rate of cure than operating first and then giving chemotherapy. Patients in this study will receive 5-fluorouracil/leucovorin/oxaliplatin (FOLFOX, a standard colon cancer treatment regimen) and bevacizumab (a drug usually used to treat advanced colon cancer after surgery).

The standard treatment for colon cancer is first to operate, and then, if the tumor is advanced, give chemotherapy for about 6 months. However, surgery delays the time until chemotherapy can begin, since the body needs time to heal from the operation. During this time, any cancer cells remaining in the body may be allowed to grow. Giving chemotherapy first could attack the cancer cells right from the start. In addition, the blood vessels that feed the cancer cells are unbroken before surgery, and chemotherapy can travel directly to the cancer.

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a confirmed diagnosis of locally advanced colon cancer that is amenable to being removed surgically.
  • Patients may not yet have had surgery to remove the primary colon cancer.
  • Patients must be candidates for FOLFOX and bevacizumab therapy.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 18 or older.

For more information and to inquire about eligibility for this study, please contact Dr. Leonard Saltz at 212-639-2501.

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