The Clinical Research E-News

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1 Volume 3: ISSUE 9: May 18, 2011 The Clinical Research E-News Jefferson Kimmel Cancer Network: For urgent clinical trial questions or assistance please page: Now Open: RTOG 0837, A Randomized, Phase II, Double-Blind, Placebo-Controlled Trial of Conventional Chemoradiation and Adjuvant Temozolomide Plus Cediranib Versus Conventional Chemoradiation and Adjuvant Temozolomide Plus Placebo in Patients With Newly Diagnosed Glioblastoma. Coming soon: ACOSOG Z1041, A Randomized Phase III Trial Comparing a Neoadjuvant Regimen of FEC-75 Followed By Paclitaxel Plus Trastuzumab With a Neoadjuvant Regimen of Paclitaxel Plus Trastuzumab Followed by FEC-75 Plus Trastuzumab in Patients with HER-2 Positive Operable Breast Cancer C70604, A Randomized, Phase III Study of Standard Dosing versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer E2108, A Randomized Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Women with Metastatic Breast Cancer E3108, A Phase II Prospective Trial Correlating Progression Free Survival with CYP2D6 Activity in Patients with Metastatic Breast Cancer Treated with Single Agent Tamoxifen.

2 E7208, A Randomized Phase II Study of Irinotecan and Cetuximab with or without the Anti-angiogenic Antibody, Ramucirumab (IMC-1121B), in Advanced, K-ras Wild-type Colorectal Cancer Following Progression on Bevacizumab-Containing Chemotherapy. RTOG 0724, Phase III Randomized Study of Concurrent Chemotherapy and Pelvic RT With or Without Adjuvant Chemotherapy in High-Risk Patients with Early-Stage Cervical Carcinoma Following Radical Hysterectomy RTOG 1008, A Randomized Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors SWOG 1007, A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less. If your site is interested in participating in any of these studies please contact Rolma Gano at or Rolma.gano@jeffersonhospital.org. Regulatory Update: RTOG 0539: Amend #2 RTOG 0631: Temporary Closure N0577 NSABP FB-5 S0518: Revisions #5-6 NSABP B46-I: Amendment #2, 4 Please contact Rolma Gano with any repository or other regulatory related questions.

3 CTSU Update: CTSU New ID Search: The CTEP ID Search is now available to all CTSU users under the Regulatory Tab on the CTSU website. To search for a CTEP ID enter a first name and last name and select <Search>. The resulting query will display all possible matches. Information displayed includes the name, CTEP ID, CTEP status, status expiration date, city, and state/zip. Please note you may use a partial first and/or last name when searching. Please contact Joshua Schoppe with any CTSU related issues at or Joshua.Schoppe@jeffersonhospital.org ECOG Update: E1305: A Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients with Recurrent or Metastatic Head and Neck Cancer: ECOG is hoping to gain further insight on barriers to accrual with a survey. The survey has 10 questions and will take less than 5 minutes to complete. You may access the survey by clicking on the following link Please submit your survey responses by Friday, May 27, ECOG Spring Meeting being held in Boston, MA from June 10 th -12 th. ECOG Agenda Summary Report and Interim Reports for June 2011 Meeting can be viewed by going to this link (Adobe Reader required): If you have an ECOG related question please contact Joshua Schoppe. NSABP Update: B-44-I BETH: Bevacizumab with Trastuzumab Adjuvant Therapy in HER2+Breast Cancer) A Multicenter Phase III Randomized Trial of Adjuvant Therapy for Patients with HER2-Positive Node-Positive or High Risk Node-

4 Negative Breast Cancer Comparing Chemotherapy Plus Trastuzumab with Chemotherapy Plus Trastuzumab Plus Bevacizumab: Reminder all BETH patients need to be re-consented at their next clinic visit with consent addendum #2. B-46-I: A Phase III Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women with Node-Positive or High- Risk Node-Negative, HER2-Negative Breast Cancer: Reminder: amendment #4 and consent addendum #2 have been approved. All previously enrolled patients, regardless of their treatment arm, should be re-consent using the consent addendum. All new patients should be consented using the new consent dated 4/14/11. If you have an NSABP related question please contact Vicki Squire at vicki.squire@jeffersonhospital.org or at RTOG Update: RTOG Semiannual Meeting Materials Available on Web: The RTOG semiannual meeting will be held June 16 19, 2011 at the Loews Philadelphia Hotel in Philadelphia, PA. Hotel reservations must be made by May 26th to ensure availability. Register at the RTOG website: Please contact Joshua Schoppe or Vicki Squire with any RTOG related issues. Jefferson Oncology Group (JOG) Update: If your site has any JOG inquiries please contact either Joshua Schoppe or Vicki Squire.

5 Jefferson Kimmel Cancer Center Network Homepage: This page contains links to the Remote Access Portal as well as the clinical trial document repository. Upcoming Events: ECOG Semiannual Meeting, Boston, MA: June CRA Quarterly Meeting, Philadelphia, PA: June 22- Virtual Meeting: agenda and dial information will be available soon. RTOG Semiannual Meeting, Philadelphia, PA: June The Clinical Research E-News Archive is now located on the Kimmel Cancer Center webpage under the JKCCN Member Area: Please provide feedback and any suggestions to Joshua Schoppe at or