Inaugural Imaging Forum Sets Positive Precedence  

 

The inaugural ECOG-ACRIN Imaging Researchers' Workshop brought together a diverse group of attendees who share a common interest in advancing oncologic imaging clinical trials. Nearly 150 people, including radiology and nuclear medicine physicians, oncologists, clinical trial methodologists, imaging technologists, and research associates, attended the October 4, 2012 workshop that was held in Arlington, VA. The two-tracked meeting offered separate, concurrent programs for technologists and investigators.

 

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Dr. Schneider to Give Keynote at Group Meeting  

 

Dr. Schneider Bryan P. Schneider, MD, recipient of the 2012 Young Investigator Award, has been invited to discuss his research on breast cancer biomarkers at the Fall 2012 Group Meeting as part of the recognition associated with the award. 

 

 

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Applications Now Being Accepted for 2013 Paul Carbone MD, Fellowship

Paul Carbone MD
 
The ECOG Research and Education Foundation is pleased to announce that it is now inviting senior hematology and oncology fellows pursuing cancer clinical research at a current ECOG member institution in good standing to apply for its 2013 Paul Carbone, MD Fellowship.  
 
 
  
2013 Young Investigator Award Call for Nominees  

Members of the ECOG-ACRIN Cancer Research Group have the opportunity to honor young Group talent by nominating an investigator less than 46 years of age for the 2013 Young Investigator Award. The nomination process for this award, one of the Group's top distinctions, is open from now until April 19, 2013. 

 

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Young Investigators to Present Diverse Clinical and Translational Research at Upcoming Group Meeting

The 12th Annual ECOG Young Investigator's Symposium (now known as the ECOG-ACRIN Young Investigator Symposium) will take place in conjunction with the full ECOG-ACRIN Fall Group Meeting. This year, Joseph A. Sparano, MD, Program Chair, has selected eight abstracts to be presented at the Symposium.

 
  
Trial Activations 
 
The following trials were activated between September 1 and October 31, 2012.

E2810

Randomized, Double-Blind Phase III Study of Pazopanib vs. Placebo in Patients with Metastatic Renal Cell Carcinoma Who Have No Evidence of Disease Following Metastasectomy

NCT01575548

Study Chair: Leonard J. Appleman, MD (Dana-Farber Cancer Institute)

Accrual Goal: 180

Date Activated (Projected Completion): August 8, 2012 (February 2014)

  
ACRIN 6698 

Diffusion-Weighted MR Imaging Biomarkers for Assessment of Breast Cancer Response to Neoadjuvant Treatment: A Sub-study of the I-SPY 2 TRIAL(Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And MoLecular Analysis) NCT01564368        

Study Chair: Nola M. Hylton, PhD (University of California, San Francisco)              

Accrual Goal: 304

Date Activated (Projected Completion): August 27, 2012 (February 2015)

  

E2511                     

Phase I and Randomized Phase II Double Blind Clinical Trial of Cisplatin and Etoposide in Combination with Veliparib (ABT-888) or Placebo as Frontline Therapy for Extensive Stage Small Cell Lung Cancer NCT01642251 

Study Chair: Taofeek Owonikoko, MD, PhD (Winship Cancer Institute of Emory University)

Accrual Goal: 168

Date Activated (Projected Completion): September 28, 2012 (January 2014) 

  
Trial Reactivations 
 
The following trials were reactivated between September 1 and October 31, 2012.

E3A06                    

Randomized Phase III Trial of Lenalidomide versus Observation Alone in Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma NCT01169337

Date Reactivated: August 25, 2012

 

E6508                      

A Phase II Study of L-BLP25 and Bevacizumab in Unresectable Stage IIIA and IIIB Non-Squamous Non-Small Cell Lung Cancer after Definitive Chemoradiation NCT00828009

Date Reactivated: October 9, 2012 

  
Trial Closures
 

The following trials were closed between September 1 and October 31, 2012.

 

E4A08                    

A Randomized Phase III Trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for Untreated Patients with Systemic Light-Chain (AL) Amyloidosis Ineligible for Autologous Stem-Cell Transplantation NCT01078454

Date Closed: September 7, 2012

 

ACRIN 6688          

Safety and Efficacy Study of FLT Radiolabeled Imaging Agent with PET Scan in Invasive Breast Cancer NCT00572728

Date Closed: September 28, 2012

 

E2208                     

Randomized Phase II Study of Paclitaxel with or without the Anti-IGF-IR mAb Cixutumumab (IMC-A12) as Second Line Treatment for Patients with Metastatic Esophageal or GE Junction Cancer NCT01142388

Date Closed: October 15, 2012

  
Trials Approved, Soon To Be Activated

The following trials were approved between September 1 and October 31, 2012; activation dates to come.

 

E3611                     
A Randomized Phase II Study of Ipilimumab at 3 mg/kg or 10 mg/kg Alone or in Combination with High Dose Interferon-Alpha in Advanced Melanoma NCT01708941

E1512                     

A Randomized Phase II Trial of Erlotinib, Cabozantinib, or Erlotinib Plus Cabozantinib as 2nd or 3rd Line Therapy in Patients with EGFR Wild-Type NSCLC NCT01708954 

 

E2512                     

A Phase I/Randomized Phase II Study of Docetaxel with or without AZD4547 in Recurrent FGFR1-Amplified Squamous Non-Small Cell Lung Cancer (not yet posted at ClinicalTrials.gov)

 

ACRIN 6701          

Studying Repeated Dynamic Contrast-Enhanced Magnetic Resonance Imaging and Diffusion-Weighted Imaging in Patients Diagnosed with Prostate Cancer NCT01562223

 

E2211                     

A Randomized Study of Temozolomide or Temozolomide+Capecitabine in Patients with Advanced Pancreatic Neuroendocrine Tumors (not yet posted at ClinicalTrials.gov)

 

ACRIN 6694          

(Alliance A011104)

Effect of Preoperative Breast MRI on Surgical Outcomes, Costs, and Quality of Life of Women with Breast Cancer (not yet posted at ClinicalTrials.gov)

 

ACRIN 6696

(RTOG 1201)         

A Phase II Randomized Trial of High versus Standard Intensity Local or Systemic Therapy for Unresectable Pancreatic Cancer (not yet posted at ClinicalTrials.gov)  

 

  
PrECOG Trials Open and Enrolling Patients
 

PrECOG, LLC is a not-for-profit limited liability research company that develops and conducts clinical trials in all areas of oncology in conjunction with industry partners. PrECOG trials are available through an established network of investigators and institutions formed from the ECOG membership.

 

PrE0502: An Open-Label, Randomized, Phase IIIb Trial Evaluating the Efficacy and Safety of Standard of Care +/- Continuous Bevacizumab Treatment Beyond Progression of Disease in Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) after First-Line Treatment with Bevacizumab Plus a Platinum Doublet-Containing Chemotherapy. 

 

PrE0801 aka NEXT: Subsequent Exposure to Tyrosine Kinase Inhibition (TKI) at Recurrence After Adjuvant Therapy in Renal Cell Carcinoma 

 

PrE0901: Phase I Dose Finding/Phase II Placebo-Controlled Trial of Eltrombopag During Consolidation Therapy in Adults with Acute Myeloid Leukemia (AML) in Complete Remission

 

PrE1003: A Phase I/II Study of the Tolerability of Lenalidomide and Low-Dose Dexamethasone in Previously Treated Multiple Myeloma Patients with Impaired Renal Function

 

Read more...  

 
  
Educational Materials Available at the Group Meeting

Printed educational information for physicians and patients will be available at the upcoming Group meeting.  

 

Trial Education

Materials for physicians and patients are available for the following protocols, which are currently active and enrolling patients:
  • ECOG-ACRIN protocol E2410
  • ACRIN protocols 6685 and 6690
  • ECOG protocols E1A10, E1208, E1305, E1411, E1505, E1609, E2108, E2511, E2810, E2905, E3508, and E5508
  • PrECOG protocols PrE0102, PrE0502, PrE0801, and PrE1003 (physician materials only)

Studies in Development

 

Physician fact sheets are available for the following studies that are currently in development:

  • E1512, E2211, E2512, and E3611

Other Educational Materials

 

The following educational materials are also available:

  • A Guide to Clinical Trials for Cancer Patients
  • Guia de Ensayos Clinicos para Pacientes con Cancer
  • Brochures describing the SOAPP website
  • Fact sheets about TRIAD
  • Brochures describing PrECOG, LLC

November 2012
In This Issue
Inaugural Imaging Forum
Dr. Schneider to Give Keynote
2013 Fellowship Info
Call for Nominees
Investigator Symposium
Trial Activations
Trial Reactivations
Trial Closures
Trials Approved
Active PrECOG Trials
Group Mtg Handouts
Latest Group Mtg Info
E2410 Imaging Info
Imaging Qualifications
In Case You Missed It...
Recognitions
Group Meeting Sponsors
newsletter sign up
Latest Group Meeting Info

 

Need Answers to E2410 Imaging Questions? ACRIN Personnel Ready to Respond

E2410, a phase 2 study of response-adapted chemotherapy based on positron emission tomography (PET) in patients with unfavorable stage I/II Hodgkin's lymphoma, is currently recruiting patients.

 

The design of E2410, the first joint clinical trial of ECOG-ACRIN, enables the integration of interim PET scans into the decision-making process of treating patients. Although many ECOG sites have some experience with imaging studies, obtaining the imaging qualifications needed to participate in E2410 could be a challenge for sites new to the process. Personnel from ACRIN recognize these challenges and are available to provide sites with information and support.

 

For questions regarding PET/computed tomography (CT) review, PET scanner image qualification, and image submission, contact ACRIN personnel:

 

Rebecca DiGati 

(215) 574-3175

or

Donna Hartfeil 

(215) 717-2765

 

Numerous other resources are available to help healthcare professionals and patients learn more about E2410. Educational materials are publicly accessible at the E2410 Trial Education page.

Attention Community-based Sites! Are You Qualified for Imaging Studies?

 

Are you interested in championing participation in clinical trials with imaging aims at your site? If so, contact us now! The ECOG-ACRIN Cancer Research Group has personnel in place to provide all of the guidance and support you need to participate in imaging research, including scanner qualification, image submission, and other imaging-specific research requirements. 

 

Read Dr. Schnall's Open Letter...

In Case You Missed It... New
York Times
Coverage of Pain Management Study 

On September 20, 2012, the New York Times published an article discussing the findings of the Symptom Outcomes and Practice Patterns (SOAPP) study, an observational trial undertaken by ECOG's Symptom Management Committee and Patient-Centered Outcomes and Survivorship Committee to explore pain and analgesic prescribing in medical oncology outpatients with breast, colorectal, lung, or prostate cancer.
 
 

Read the study abstract

  

Read the article from our September newsletter: First SOAPP Manuscript Published

Recognitions and Distinctions 

Mitchell D. Schnall, MD, PhD named Chair, Department of Radiology, Perelman School of Medicine, University of Pennsylvania; elected a member of the Institute of Medicine

Now Posted - E3508 Educational Materials
 
Materials are now publicly available following the October webinar with study chair Athanassios Argiris. ECOG seeks 41 additional patients to meet the accrual goal.
 
Fall 2012 Group Meeting Sponsors

ECOG-ACRIN wishes to acknowledge and thank the following corporations for their support:

 

Abbott Laboratories

 

Amgen, Inc.

 

Colene Corporation

 

Eisai, Inc.

 

Genentech, Inc.

 

Genomic Health, Inc.

Lilly USA, LLC

 

Millennium Pharmaceuticals, Inc.

 

Novartis Pharmaceuticals, Corp. 

 

Onyx Pharmaceuticals, Inc.

 

Otsuka America Pharmaceutical, Inc.

 

Sanofi US

 

Sigma-Tau Pharmaceuticals, Inc.

 
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