The Clinical Research E-News

Transcription

1 Volume 2: ISSUE 5: March 10, 2010 The Clinical Research E-News Coming soon: AZ1071, A Phase II Study Evaluating the Role of Sentinel Lymph Node Surgery and Axillary Lymph Node Dissection Following Preoperative Chemotherapy in Women with Node Positive Breast Cancer (T1-4, N1-2, M0) at Initial Diagnosis NSABP FC-6, A Phase II Study to Determine the Surgical Conversion Rate in Patients Receiving Neoadjuvant mfolfox7 Plus Cetuximab for Unresectabel Wild-Type K-RAS Colorectal Cancer with Metastases Confined to the Liver E1208, A Phase III Randomized, Double-Blind Trial of Chemoembolization with or without Sorafenib in Unresectable Hepatocellular Carcinoma (HCC) in Patients with and without Vascular Invasion. E2508, A Randomized Double-Blind Placebo Controlled Phase II Trial Evaluating Erlotinib in Non-Smoking Patients with (Bevacizumab-eligible and Ineligible) Advanced Non-Small Cell Lung Cancer (NSCLC) E3903, Ancillary Laboratory Protocol for Collecting Diagnostic Material on Patients Considered for ECOG Treatment Trials for Leukemia or Related Hematologic Disorders. GOG258, A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel Vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma

2 NCCTG/NO577, Phase III Intergroup Study of Radiotherapy versus Temozolomide alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide for Patients with 1p/19q Codeleted Anaplastic Glioma RTOG 0539, Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas. RTOG0627, Phase II Trial of Dasatinib in Patients with Recurrent Glioblastoma Multiforme, will be opened to the JKCCN only RTOG 0631, Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis. RTOG0831, A Randomized, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate the Effectiveness of a Phosphodiesterase 5 Inhibitor, Tadalafil, in Prevention of Erectile Dysfunction in Patients Treated with Radiotherapy for Prostate Cancer. SWOG0521, A Randomized Trial of Maintenance Versus Observation for Patients with Previously Untreated Low and Intermediate Risk Acute Promyelocytic Leukemia (APL), Phase III. If your site is interested in participating in any of these studies please contact Rolma Gano at or Rolma.gano@jeffersonhospital.org. Regulatory Update: The following studies have had recent consent form changes or updated letters posted on the repository website: RTOG 0848 ECOG 1305 RTOG 0227 CLAGB10501 ECOG 2205 CALGB80403

3 ECOG 1A00 SWOG 0307 ECOG 1508 RTOG0538 If any of these studies pertain to your site please visit the repository at: Please contact Rolma Gano with any repository or other regulatory related questions. Quality Assurance Update: Please contact Kelly Shipman with any QA related issues at or CTSU Update: The following protocols are now in OPEN and available for site enrollments: S0600, S0916, E1305, and E5202. Please see the OPEN tab on the CTSU Members web site for more information about the protocols in OPEN. If you have a CTSU related question please contact Joshua Schoppe at or Joshua.schoppe@jeffersonhospital.org. ECOG Update: OPEN System Update: The ECOG Registration System will be unavailable on Wednesday March 10, between 5 PM and 6 PM Eastern time, so that we can activate E2905 in the OPEN system.. All new registrations to either of these trials must be done through the OPEN system. You must be designated as a site registrar in order to have access to this operation. Contact your ECOG administrator if you are unclear of your site role. E1508, A Randomized Phase II Study of Cisplatin and Etoposide in Combination with either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMC-A12 for Patients with Extensive Stage Small Cell Lung Cancer, was suspended effective March 5, This is a protocol-specified and planned

4 suspension. Given this is the first time either of the two experimental agents is combined with cisplatin/etoposide, toxicity will be assessed after each patient has completed 2 cycles of therapy. Accrual will resume after CTEP has reviewed the safety data. ECOG Performance Monitoring: The next Performance Monitoring data cut-off date of 3/31/2010 is approaching. Any data received on or before 3/31/2010 will be included in the upcoming Performance Monitoring. Data received after 3/31/2010 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 Spring Meeting: The ECOG spring meeting will be held at the JW Marriott Hotel in Washington, D.C. June 11 th through the 13 th. Meeting registration will be done online again for this meeting. To register for the Group Meeting, please use the following link below. Please note that the schedule is updated on an ongoing basis. The schedule provided is for current reference only and is subject to change at any time. ECOG strongly recommends that all meeting attendees check the most current schedule online before making travel arrangements, as ECOG will not be responsible for ticket change fees due to scheduling changes. If you have an ECOG related question please contact Joshua Schoppe. NSABP Update: NSABP Group Meeting: Registration is now open for the NSABP Group Meeting in San Francisco scheduled for April The registration link below is not posted on the NSABP website.

5 Registration deadline is March 22nd, but you are advised to register as soon as possible to guarantee a room in the Westin. A tentative meeting schedule has been posted on the registration website. If you have an NSABP related question please contact Vicki Squire at vicki.squire@kimmelcancercenter.org or at RTOG Update: The February issues of the RTOG 0539 and RTOG 0436 newsletters were just issued and can be found at and If you have an RTOG related question please contact Kelly Shipman. Jefferson Oncology Group (JOG) Update: BioNumerik Pharmaceuticals, Inc, Phase 3 Study of Tavocept vs Placebo in Patients With Newly Diagnosed or Relapsed Advanced (Stage IIIB/IV) Primary Adenocarcinoma of the Lung Treated With Docetaxel or Paclitaxel Plus Cisplatin. More information about this study can be found at If your site is interested please contact Josh 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 Quarterly CRA Meeting, TJU: Mar 24, The meeting will be virtual meeting. Oral Cancer Screening Event, TJU: April 14, 2010 NSABP Group Meeting, San Francisco: April ECOG Spring Meeting, Washington, D.C.: 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