The Clinical Research E-News

Transcription

1 ISSUE 10: May 20, 2009 The Clinical Research E-News New Activations at TJU: No new activations. Regulatory Update: The following studies have had recent consent form changes posted on the repository website: R0320 E1505 PACCT-1 E2805 R0415 R0617 E2804 C90203 R0534 R0227 N0147 If any of these studies pertain to your site please visit the repository at: Please contact Rolma Mancinow at or with any repository related questions. Regulatory Corner: No new updates. Check back in 2 weeks. Please contact Rolma Mancinow with any Regulatory issues. Quality Assurance Update: No new updates. Check back in 2 weeks. Please contact Kelly Shipman with any QA related issues at Kelly.shipman@jeffersonhospital.org

2 CTSU Update: CALGB 80101, Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma will close to accrual effective May 29, 2009 at 5pm ET. If you have a CTSU related question please contact Joshua Schoppe at Joshua.schoppe@jeffersonhospital.org ECOG Update: E2607, A Phase II Trial of Dasatinib in Patients with Unresectable Locally Advanced or Stage IV Mucosal, Acral and Solar, activated on May 1, If your site is interested in participating, please contact Joshua Schoppe. PACT1: Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx Trial, has a revised eligibility checklist for Step 2 registration. The new checklist allows for stratification for Recurrence Score (RS) scores at Step 2. Reminder: SPRING ECOG MEETING: Please also register if you haven't already done so: If you have an ECOG related question please contact Joshua Schoppe NSABP Update: FB-5: A Phase II Clinical Trial of Epirubicin Plus Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and Bevacizumab Given as Neoadjuvant Therapy forher2-positive Locally Advanced Breast Cancer or Given as Adjuvant Therapy for HER2-Positive Pathologic Stage III Breast Cancer, closed to accrual on May 19, The last of 105 patients was registered on May 18, 2009.

3 Appeal to complete: B-39/RTOG 0413, A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer: Accrual to this trial slowed for a time after the amendment to close accrual to the low risk group was issued. The importance of completing the trial was emphasized at the recent NSABP Group Meeting. All participating sites were encouraged to accrue two patients within the next six months to bring the trial to completion before the end of the year. Points to note: 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: Maximum turn around time for central HER2 testing is 10 days. Drug may be ordered once the first consent form (consent for HER2 testing) is signed Instruct patient to record menstrual cycles between baseline and 18 months to facilitate completion of Form Menopasual Status (MS). If you have an NSABP related question please contact Vicki Squire RTOG Update: RTOG 0625/ACRIN 6677, "A Randomized Trial of Bevacizumab with Irinotecan or Bevacizumab with Temozolomide in Recurrent Glioblastoma," closed to patient accrual on May 19, 2009 because this study has met its primary accrual objective. RTOG 0235/ACRIN 6668, "Positron Emission Tomography Pre- and Post- Treatment Assessment for Locally Advanced Non-small Cell Lung Cancer," closed to patient accrual on May 15, 2009 due to successful completion of study accrual.

4 Reminder: RTOG Meeting: Registration and attendee information for the upcoming RTOG Semiannual Meeting has been posted on the RTOG website. The meeting will be held June 25-28, 2009, at the Chicago Marriott Downtown Magnificent Mile. Information about the meeting can be found at Please take advantage of the opportunity to complete your meeting registration in advance via the website. Jefferson Oncology Group (JOG) Update: Wyeth 3144A WW, A Randomized Double Blind Placebo-Controlled Trial of Neratinib (HKI-272) After Trastuzumab in Women With Early-Stage HER-2/neu Overexpressed/Amplified Breast Cancer. This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbb-2 (HER-2) positive metastatic or locally advanced breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and to extend the lives of women with erbb2 (HER-2) positive breast cancer. The study will also compare the safety of the two regimens and compare quality of life of patients on the two regimens. More information can be found at clinicaltrials.gov. If you site is interested, please contact Joshua Schoppe or Vicki Squire. Reminder JKCCN CRA Meeting: The next CRA meeting will be held at TJU on Wednesday, June 24, 2009: 9am- 1pm.

5 Reminder: Save the Date, Joint HCC Symposium, KCC at Jefferson, FCCC and Abramson Cancer Center at the University of Pennsylvania: Drs. Brian Carr, Professor of Medicine at Jefferson Medical College, Minhhuyen Nguyen, Director of Clinical Gastroenterology at Fox Chase Cancer Center, and Weijing Sun, Associate Professor of Medicine at the Abramson Cancer Center at the University of Pennsylvania, would like to invite you to attend the: Philadelphia Hepatoma Symposium Wednesday, June 10, 2009 at 5:00pm - 8:45 pm. Cocktails, Dinner and free parking will be provided. An agenda and early registration is available at 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 at Joshua.schoppe@jeffersonhospital.org