The Clinical Research E-News

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1 Volume 3: ISSUE 8: May 5, 2011 The Clinical Research E-News Jefferson Kimmel Cancer Network: For urgent clinical trial questions or assistance please page: Now Open: E2906, Phase III randomized trial of Clofarabine as induction and postremission therapy vs. standard Daunorubicin and Cytarabine induction and intermediate dose Cytarabine post remission therapy, followed by Decitabine maintenance vs. observation in newly diagnosed acute myeloid leukemia in older adults (age >60 yrs) GOG 252, A Phase III Clinical Trial of Bevacizumab with IV Versus IP Chemotherapy, in, Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma GOG 262, A Randomized Phase III Trial of Every-3-weeks Paclitaxel versus Dose Dense Weekly Paclitaxel in Combination with Carboplatin Plus Concurrent and Consolidation Bevacizumab in the Treatment of Primary Stage III or IV Epithelial Ovarian, Peritoneal or Fallopian Tube Cancer 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.

2 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. 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,

3 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 Regulatory Update: RTOG 0526: Amend #3 RTOG 0622: Amends #3 & 4 RTOG 0617 Amend #8 CALGB 90601: Update #3 NSABP B-36: Amend #5 SWOG 0600: RTOG 0813: Amend #4 NSABP B-46-I: Addendum #2 RTOG 0837: NEW STUDY GOG 252: NEW STUDY GOG 262: NEW STUDY SWOG 0777: Revisions # 8,9,10 CALGB NSABP R-04: Amend #7 RTOG 0937: Amend #1 C30610/R0538, Update #6 R0436 E2408 C40502, Update #4 GOG 258 S0221 BETH, Addendum #2 Please contact Rolma Gano with any repository or other regulatory related questions. CTSU Update: CTSU Funding Information Folder: CTSU has added a new feature that will show the funding that is available for trials on the CTSU menu. You can access this information by clicking on the Funding Information folder that appears under each protocol on the protocol tree.

4 N0147, A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5- Fluorouracil (5-FU)/Leucovorin (CF) with or without Cetuximab (C225) after Curative Resection for Patients with Stage III Colon Cancer: Study reminder: Starting on Wednesday, June 1st, 2011, N0147 documents including Case Reports Forms (CRFs), Reports, outstanding CTSU generated Data Clarification Forms (DCFs) and any other related documents are to be MAILED DIRECTLY TO NCCTG (unless the form directs you to fax it directly to NCCTG). Please contact Joshua Schoppe with any CTSU related issues at or Joshua.Schoppe@jeffersonhospital.org ECOG Update: E1505, Adjustment to Expectancy Schedule for E1505, /A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab in Patients with Completely Resected StageIB-IIIA Non-Small Cell Lung Cancer (NSCLC): Notice Regarding Forms Expectancy: Effective Monday, May 2, 2011 the grace period for submitting Due survival information will be reduced from 45 days to 7 days. Survival is updated from the Chemotherapy Treatment form, the Disease and Vital Status form, and the Off Treatment form. These will be the only three forms affected. ECOG Spring Meeting being held in Boston, MA from June 10 th -12 th. Registration for the meeting is now OPEN and will be done completely online. To register for the Group Meeting, please use the following link: If you have an ECOG related question please contact Joshua Schoppe.

5 NSABP Update: NSABP B-33: A Randomized, Placebo-Controlled, Double-Blind Trial Evaluating The Effect Of Exemestane In Clinical Stage T1-3 N0-1 M0 Postmenopausal Breast Cancer Patients Completing At Least Five Years Of Tamoxifen Therapy: Please be certain that you have returned any undispensed clinical supplies of Exemestane or matching placebo received from CTEP for this trial. All drug should be returned by May 10, 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. Jefferson Kimmel Cancer Center Network Homepage: This page contains links to the Remote Access Portal as well as the clinical trial document repository.

6 Upcoming Events: JKCCN Breast Care Coordinators Networking Meeting: Philadelphia, PA: May 13 th ECOG Semiannual Meeting, Boston, MA: June CRA Quarterly Meeting, Philadelphia, PA: June 22- Virtual Meeting 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