Volume 4: ISSUE 6: August 28, 2012 The Clinical Research E-News Jefferson Kimmel Cancer Center Network: For urgent clinical trial questions or assistance please page: 877-656-9004 New Trials Opened at the Kimmel Cancer Center at Jefferson: 1. New Prostate Cancer Clinical Trial Announcement: A Phase 2 Assessment of the Diagnostic Accuracy of 99mTc-MIP-1404 Imaging in Men with High-Risk Prostate Cancer Scheduled for Radical Prostatectomy (RP) and Extended Pelvic Lymph Node Dissection (EPLND) Compared to Histopathology a. Eligibility: Male aged 21 years or older. Biopsy confirmed presence of adenocarcinoma of the prostate gland. At high-risk for metastatic disease by a stage of ct3, ct4, or a total nomogram score of greater than or equal to 130. Scheduled to undergo radical prostatectomy with extended pelvic lymph node dissection. b. Study Design: Newly-diagnosed prostate cancer patients at high-risk for metastatic disease who are scheduled for RP with EPLND will be enrolled in the study. Subjects will have an MRI as part of study screening. Subjects will receive a single IV dose of 99mTc-MIP-1404 (study drug) followed by both whole-body planar imaging and SPECT/CT imaging 3-6 hours after injection. As standard of care, subjects will undergo RP with EPLND surgery and histological assessment of specimens at least one week but no more than 3 weeks after study drug dosing. 99mTc-MIP-1404 image data will be evaluated for visible uptake within the prostate gland and by regional assessment of nodal disease. These findings will then be compared against histopathology as the true standard. c. Contact: Christine Hubert at 215-955-9954 or christine.hubert@jefferson.edu Pending Studies for Network Participation: N0949, Randomized Phase III Trial of mfolfox7 or XELOX Plus Bevacizumab Versus 5-Fluorouracil/Leucovorin or Capecitabine Plus
Bevacizumab as First-line Treatment in Elderly Patients with Metastatic Colorectal Cancer N0148, A Phase II/III Trial of Neoadjuvant FOLFOX with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision RTOG1106, A Randomized Phase II Trial of Individualized Adaptive Radiotherapy Using During-Treatment FDG-PET/CT and Modern Technology in Locally Advanced Non-Small Cell Lung Cancer (NSCLC) RTOG1115, Phase III Trial of Dose Escalated Radiation Therapy and Standard Androgen Deprivation Therapy (ADT) with a GNRH Agonist vs. Dose Escalated Radiation Therapy and Enhanced ADT with a GNRH Agonist and TAK-700 for Men with High Risk Prostate Cancer RTOG1119, Phase II Randomized Study Of Whole Brain Radiotherapy In Combination With Concurrent Lapatinib In Patients With Brain Metastasis From HER2-Positive Breast Cancer- A COLLABORATIVE STUDY OF RTOG AND KROG RTOG1122, Phase II Double-Blinded Placebo-Controlled Study of Bevacizumab with or without AMG 386 in Patients with Recurrent Glioblastoma or Gliosarcoma If your site is interested in participating in any of these studies please contact Joshua Schoppe at 215-955-0448 or at Joshua.schoppe@jeffersonhospital.org.
Regulatory Update: E7208-Addendum #4 R0837 E1305 E1505- Addendum #12 RTOG 1012- Amendment #1 CALGB 10403-/Update#8 RTOG 1102 RTOG 1012 RTOG 0839- temporarily closed to accrual JOG60 JOG61-closed to accrual ECOG 2905-Amendment QA to consent form All studies bolded and italicized require a re-consent of patients currently receiving treatment or within 30 days of receiving their last study dose. Please contact Rashada Dawson at 215-955-2135 or Rashada.Dawson@jeffersonhospital.org with any repository related questions. CTSU Update: C90203, A Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer, effective August 15, 2012, all institutions will use the OPEN for registration/randomization of patients. C90802, Randomized Phase III Trial Comparing Everolimus Plus Placebo Versus Everolimus Plus Bevacizumab for Advanced Renal Cell Carcinoma Progressing After Treatment with Tyrosine Kinase Inhibitors, effective August 15, 2012, all institutions will use the OPEN for registration/randomization of patients. S0518, Phase III Prospective Randomized Comparison of Depot Octreotide Plus Interferon Alpha Versus Depot Octreotide Plus Bevacizumab in Advanced, Poor Prognosis Carcinoid Patients, has met its accrual goal and
will permanently close to accrual effective September 1, 2012 at 11:59 p.m. Pacific. Please contact Joshua Schoppe with any CTSU related issues. ECOG Update: Upcoming Performance Monitoring: The next Performance Monitoring data cut-off date of September 30, 2012 is approaching. Any data received on or before September 30, 2012 will be included in the upcoming Performance Monitoring. Data received after September 30, 2012 will be considered late. It is important to remember that data timeliness will be evaluated by assessing two components: The rate of CRF submitted and the rate of survival follow-up. To avoid penalties, each evaluable ECOG institution must have a score of 90% or better on each component. ECOG-ACRIN Fall Group Meeting - REGISTRATION NOW OPEN!!! Please use the follow link to register and download information for the upcoming ECOG Fall Group Meeting in Hollywood, FL on Friday, November 9, 2012 - Sunday, November 11, 2012: https://www.regonline.com/ecog_fall2012 Please contact Joshua Schoppe with any ECOG related issues. NSABP Update: B-49: A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer- This new NSABP trial is now open at 4 JKCCN sites. Congratulations to Hematology and Oncology Assoc. of NE PA, PC for being the first JKCCN member to randomize a patient to B-49.
Changes in Data Collection Procedures: There will be changes in data collection procedures for the following protocols beginning October 1, 2012: B-30, B-31, B-32, B-34 and C-07. Please go to this link to view the details: https://members.nsabp.pitt.edu/changes_in_data_collection_procedures. pdf RTOG Update: RTOG 0837, 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, please submit any outstanding MRI s for the following time points: Pre Opt, Post Opt, and 6months. The above mentioned scans are needed to complete the central review for the RTOG endpoint of 6 month progression free survival. All outstanding MRIs are be received by September 7, 2012. Please be sure when submitting scans to include the attached Imaging Transmittal Form for each time point. Images on CD or DVD-ROM should be shipped to: American College of Radiology 1818 Market Street, Suite 1600 Philadelphia, PA 19103 Attn: 0837/RTQA RTOG 0929, Randomized Phase I/ II Study of ABT-888 in Combination with Temozolomide in Recurrent (Temozolomide Resistant) Glioblastoma- Accrual of new patients is suspended immediately and cannot resume until the IRB of record has reviewed and approved a CTEP-approved amendment created in response to this Action Letter. RTOG will submit an amendment to CTEP in the near future and will broadcast it to sites upon CTEP approval.
Jefferson Oncology Group (JOG) Update: 1. JOG62: LUX-Breast 1; An open label, randomized phase III trial of BIBW 2992 and vinorelbine versus trastuzumab and vinorelbine in patients with metastatic HER2-overexpressing breast cancer failing one prior trastuzumab treatment d. Eligibility: Histologically confirmed diagnosis of HER2-overexpression breast cancer, Stage IV metastatic disease, Must have progressed on one prior trastuzumab treatment, no more than one prior trastuzumab based therapy regimen (either adjuvant or first-line), Must have received anthracycline and/or taxane based chemotherapy for adjuvant treatment of breast cancer or first-line treatment of metastatic breast cancer e. Treatment: Experimental: Arm A: BIBW 2992 with vinorelbine patients receive BIBW 2992 tablets once daily combined with weekly intravenous infusion of vinorelbine. Active Comparator: Arm B: trastuzumab with vinorelbine patients receive weekly intravenous infusion of trastuzumab and vinorelbine DEADLINE for participation is September 10, 2012 2. JOG63: LUX-Lung 8: A randomized, open-label Phase III trial of afatinib versus erolotinib in patients with advanced squamous cell carcinoma of the lung as second-line therapy following first-line platinum-based chemotherapy treatment a. Eligibility: Diagnosis of advanced stage NSCLC squamous histology. Completion of at least 4 cycles of platinum-based doublet chemotherapy as 1st line treatment of Stage IIIB/IV NSCLC. Eligible to receive 2nd line therapy in the opinion of the investigator. Adequate Performance Status. Availability of tumor tissue material for correlative. Archived tumor tissue is acceptable. No prior treatment with EGFR directed small molecules or antibodies. b. Treatment: Experimental: Arm A: Patients receive afatinib tablets once daily. Active Comparator: Arm B: Patients receive erlotinib tablets once daily DEADLINE for participation is September 24, 2012 Please contact Joshua Schoppe if your site is interested.
Jefferson Kimmel Cancer Center Network Homepage: http://www.kimmelcancercenter.org/jkccn/. This page contains links to the Remote Access Portal as well as the clinical trial document repository. Upcoming Events: CRA Quarterly Meeting, Jefferson Campus: September 19 Annual JOG Investigators Meeting, Loews Hotel - 33rd floor: Philadelphia October 4, 530pm ECOG-ACRIN Semiannual Meeting, Hollywood, FL: November 9-11 CRA Quarterly Meeting, Jefferson Campus: December 19 NRG meeting January, San Diego, CA: Jan 24-27, 2013 The Clinical Research E-News Archive is now located on the Kimmel Cancer Center webpage under the JKCCN Member Area: http://www.kimmelcancercenter.org/jkccn/e-newsletters.html Please provide feedback and any suggestions to Joshua Schoppe at 215-955- 0448 or email Joshua.schoppe@jeffersonhospital.org