We offer numerous clinical trials to our patients through our participation in National Cancer Institute sponsored trials. We participate in two clinical trial groups; the Eastern Cooperative Oncology Group and the National Surgical Adjuvant Breast and Bowel Project. There are currently around 20 cooperative group trials open at Hinsdale Hematology Oncology. Here is an update on a few of those trials.

NSABP Trial P-5 is open for patients who have resected colon cancer. This prevention trial will use a statin drug (Crestor) to see if the incidence of cancerous polyps can be reduced in this patient population. This trial is currently accruing at low rates because oncologists often do not see patients who have resected stage II colon cancer due to the standard of care being surgery followed by observation. Only with the help of local gastroenterologists and surgeons can we accrue patients to this trial.

We are accruing well to adjuvant breast trial E5103 studying the effect of sequential therapy (4 cycles AC followed by 12 weekly treatments with Taxol +/- Bevacizumab/Placebo). With all the publicity from the FDA about bevacizumab efficacy in metastatic breast cancer, questions still need to be answered in the adjuvant population whether or not bevacizumab in newly diagnosed breast cancer will prolong recurrence and survival rates. This trial will likely close to accrual early 2011, then we will be suing NSABP B-461 to treat newly diagnosed breast cancer with TC + Bevacizumab, TC alone, or TAC in the adjuvant setting.

The TailorRx trial recently closed to accrual because of sufficient numbers of patients had been enrolled. This large Phase III randomized trial used the Oncotype test to determine a woman’s risk of recurrence of breast cancer. Those women with a recurrence score in the intermediate range were randomized to hormonal therapy alone or chemotherapy + hormonal therapy. This trial hopes to elucidate whether or not women in the intermediate range really need to have systemic chemotherapy, or if hormonal therapy will be adequate treatment. It is hoped that preliminary results will be available next spring.

Our office has five lung cancer protocols at present. For non small cell lung cancer patients in the adjuvant setting, targeted therapies (bevacizumab, IMC-A12) are used in conjunction with other standard chemotherapy drugs. Additionally, IMC-A12 is being studied in extensive stage small cell lung cancer.

We are opening another exciting trial for use in patients with advanced melanoma. This trial will randomize patients to treatment with a new monoclonal antibody, ipilimumab alone vs. ipilimumab + GM-CSF. In addition, we have another trial open for metastatic melanoma that uses low dose peg-interferon.

We are hoping that these clinical trials will give us new information on the treatment of these diseases. If you would like more information on current clinical trials we are offering, please call our office at 630-654-1790 to speak with Dr. Schneiderman or our Clinical Research Nurse.