Jefferson Kimmel Cancer Center Network Presents: The Clinical Research E-News. January 14, 2009

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1 Jefferson Kimmel Cancer Center Network Presents: January 14, 2009 The Clinical Research E-News New Activations at TJU: NCCTG N0723: A Phase III Biomarker Validation Study of Second-Line Therapy in Patients With Advanced Non- Small Cell Lung Cancer (NSCLC) Randomized to Pemetrexed Versus Erlotinib. This randomized phase III trial is studying pemetrexed to see how well it works compared with erlotinib when given as second-line therapy in treating patients with advanced non-small cell lung cancer. Regulatory Update: The following studies have had recent updated files posted on the repository website: RTOG 0615 RTOG 0822 PACCT-1 NSABP B-42 ALTTO SWOG 0307 RTOG 0415* RTOG 0521 CALGB RTOG 0534 RTOG 0521 * RTOG 0320* RTOG 0233 RTOG 9906 RTOG 9601 RTOG 9708 CALGB CALGB RTOG 0517* ECOG 1505 RTOG 0436 ALTTO (ECOG 2805)* ASSURE* ECOG 2804 (BEST TRIAL)* CALGB NSABP FB-5 ECOG 2805 C80405* R0538* C10501* R0521 R0225 R0424* E1504 S0600 E5202*

2 If any of these studies pertain to your site please visit the repository at: Please note: all bolded and starred studies have recent consent form changes. Please contact Rolma Mancinow at with any repository related questions. Continuing Reviews: by Rolma Mancinow As many of you are already aware, I contact the sites regularly to obtain information on participants on the cooperative group studies. It is important to obtain and maintain accurate information that is sent to the TJU IRB for review. To make your lives easier, I have created a form that will be sent to you as needed. The form will be pre-populated with the information that we have in our database and I will simply ask you to check the patients on the list and update us with their current status. Each year, you will be sent one of these forms to update your patients and add on any patients as well (that aren t on the list). The list is protected, and all you will have to do is to tab to the next column. There is another plus side to this, as it will assist us when we our doing our payout checks as well! Please me directly with any questions or concerns. Quality Assurance Update: Policy effective 1/1/2009, semi annual monitoring will take place at all sites. However, monitoring frequency is subject to change based on level of accrual. ECOG Update: ECOG has changed their method for mailing Data Clarification Forms (DCF's/queries). For studies activated since 2002, queries will now be sent via directly to the person at your institution designated Data Administrator by CTSU. The data administrator for the JKCCN is Kelly Shipman and she can be reached at kelly.shipman@jeffersonhospital.org.

3 In order to resolve queries, ECOG is requiring that you print them out and fax them in to the ECOG Coordinating Center with your clarification and signature (and any necessary supporting documents). For older studies (activated before 2002) ECOG will still be mailing out hard copy DCF's, which should be resolved in the usual way. Please know that everyone who has a CTEP username and password is able to log on to the ECOG website to view your 'outstanding' and 'received' electronic DCF's at the following link: You are also able to view data expectancy reports and performance monitoring reports in this area of the website. Please contact Joshua Schoppe at Joshua.schoppe@jeffersonhospital.org with any ECOG related questions. NSABP Update: IRB approval is expected soon for B-43: A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy. This is an exciting trial and all sites are urged to participate. Please contact Vicki Squire at Vicki.squire@jeffersonhospital.org for all NSABP related inquiries. RTOG Update: RTOG names new RTOG pathology Committee Chair: Anthony M. Magliocco, MD. Anthony M. Magliocco, M.D. has been appointed Pathology Committee Chair for the Radiation Therapy Oncology Group (RTOG). Dr. Magliocco is the director of the Translational Laboratory at the Tom Baker Cancer Centre in Alberta, Canada and an associate professor in the department of Oncology, Pathology & Laboratory Medicine at the University of Calgary. RTOG is a National Cancer Institute-funded national clinical trials group and is administered by the American College of Radiology.

4 "Dr. Magliocco is an internationally respected molecular pathologist with a strong clinical and research background. He has been actively involved in RTOG research for a number of years. The translational group in Calgary has become a center of excellence for protein expression using the HistoRx/Aqua technology and Dr. Magliocco is currently directing studies aimed at identifying novel molecular markers of tumor response to therapies in several different cancers, including breast cancer and gynecological malignancies," said Walter J. Curran, Jr., M.D., the RTOG Group Chair, and the Lawrence W. Davis Professor and Chair of the Department of Radiation Oncology in the Emory School of Medicine and Chief Medical Officer of the Emory Winship Cancer Institute. Jefferson Oncology Group (JOG) Update: The following trials will be open here at Jefferson University Hospital under the Principal Investigator, Edith Mitchell, MD. Please contact Joshua Schoppe or Vicki Squire if your site has any interest in participating in one or more of the following trials: Please respond if interested by January 21, Amgen : Phase 1b/2 Study of AMG 655 With mfolfox6 and Bevacizumab for First-Line Metastatic Colorectal Cancer. The clinical benefit of AMG 655 in combination with mfolfox6 and bevacizumab will be measured by progression-free survival, objective response rate, time to response, duration of response, and overall survival. Amgen : A Randomized, Phase 1b/2 Trial of AMG 102 or AMG 479 in Combination With Panitumumab Versus Panitumumab Alone in Subject With Wild-Type KRAS Metastatic Colorectal Cancer. This study is a global, multicenter, open-label phase 1b and randomized, double-blinded, 2 part, phase 2 study designed to evaluate the safety and efficacy of AMG 102 or AMG 479 in combination with

5 panitumumab versus panitumumab alone in subjects with metastatic colorectal cancer whose tumors are wild-type KRAS status. Amgen : A Phase 1b/2 Study to Evaluate the Safety and Efficacy of AMG 655 or AMG 479 in Combination With Gemcitabine as First-Line Therapy for Metastatic Pancreatic Cancer. This is a multicenter, 2-part study of AMG 655, AMG 479 or AMG 655-placebo plus gemcitabine as first-line treatment of subjects with metastatic pancreatic cancer. Enrollment into part 1 of the study has been completed. Part 2 is a randomized, placebo-controlled phase 2 segment to estimate the efficacy as assessed by 6 month survival of AMG 655, AMG 479, or AMG 655-placebo in combination with gemcitabine. In part 2, subjects will be randomized 1:1:1 to AMG 655, AMG 479, or placebo in combination with gemcitabine. Amgen : A Phase 2, Randomized, Double-Blind, Placebo- Controlled Study Evaluating the Safety and Efficacy of FOLFIRI in Combination With AMG 479 or AMG 655 Versus FOLFIRI for the Second-Line Treatment of KRAS-Mutant Metastatic Colorectal Carcinoma. Approximately 150 eligible KRAS-mutant metastatic colorectal cancer subjects who have failed first line fluoropyrimidine and oxaliplatin-based regimen with or without bevacizumab will be randomized in a 1:1:1 ratio to receive AMG 655 with FOLFIRI, or AMG 479 with FOLFIRI, or placebo with FOLFIRI. Sanofi Aventis EFC 10547: A Multinational, Randomized, Double- Blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks Versus Placebo in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer. The main objective of the study is evaluate the effectiveness of aflibercept administered once every 2 weeks in increasing the overall survival in patients with metastatic pancreatic cancer treated with gemcitabine.