From the Group Co-Chairs...

In a joint letter, Group Co-Chairs Robert L. Comis, MD, and Mitchell D. Schnall, MD, PhD, provide an update on the various National Cancer Institute grant submissions, including scoring information.

Young Investigator Symposium: Annual Call for Abstracts

The ECOG-ACRIN Cancer Research Group is accepting abstracts from now until Monday, October 7, 2013 from qualified young investigators interested in presenting their research at the 13th Annual ECOG-ACRIN Young Investigator Symposium.

Therapeutic and Diagnostic Integration of ECOG-ACRIN Continues with the Appointment of Several New Scientific Chairs

Since its inception in May 2012, the ECOG-ACRIN Cancer Research Group has embraced the challenge of developing clinical trials designed to drive the science surrounding cancer investigation forward. To this end, the Group promotes the integration of both laboratory-based and advanced imaging science into clinical trials across its three scientific programs: Cancer Control and Outcomes, Therapeutic Studies, and Biomarker Sciences.

At the Spring 2013 ECOG-ACRIN Group Meeting, Group Co-Chairs Robert L. Comis, MD, and Mitchell D. Schnall, MD, PhD, announced several new appointments to leadership positions within the scientific committees. These appointments, presented below, represent an ongoing commitment to ensure that scientific committees have therapeutic and diagnostic representation at the leadership level. Information about these individuals, including biographies, is publicly available at the ECOG-ACRIN website (www.ecog-acrin.org).

A. Bapsi Chakravarthy, MD (Vanderbilt University); Chair of the Radiation Oncology Committee

Ruth Carlos, MD (University of Michigan Health System); Diagnostic Vice Chair of the Patient-centered Outcomes and Survivorship Committee

Christopher Comstock, MD (Memorial Sloan-Kettering Cancer Center); Diagnostic Vice Chair of the Breast Committee

Laurie Loevner, MD (University of Pennsylvania); Diagnostic Vice Chair of the Head and Neck Committee

Yanming Zhang, MD (Northwestern University); Chair of the Leukemia Committee's Cytogenetics Subcommittee

ECOG-ACRIN Endorses Scientific Event on Disparities in Cancer Diagnosis and Care

The 8th Annual W. Montague Cobb/National Medical Association Scientific Symposium and Lectureship took place July 28, 2013 in Toronto, Ontario, Canada, with strong involvement from members of the ECOG-ACRIN Cancer Research Group. The event, "Navigating the Complex World of Cancer Diagnosis and Care: How Can We Minimize Disparities?", was part of the annual meeting of the National Medical Association (NMA), a US-based professional organization whose mission is to promote the collective interests of physicians and patients of African descent. ECOG-ACRIN officially endorsed the symposium and lectureship, following the tradition of ECOG, which has partnered with the NMA for many years on initiatives to increase the representation and contributions of persons of African descent in clinical trials.

Edith Mitchell, MD, FACP, Thomas Jefferson University (Philadelphia, PA) and Chair, ECOG-ACRIN Underserved Populations Committee, chairs the symposium and lectureship. This year's event featured a lecture by Harold P. Freeman, MD, founder of the Harold P. Freeman Patient Navigation Institute (New York, NY). Faculty presenters included Michael Carducci, MD, Johns Hopkins University (Baltimore, MD); Nasser Hanna, MD, Indiana University (Indianapolis, IN); and David Ilson, MD, PhD, Memorial Sloan-Kettering Cancer Center (New York, NY), all of whom are from institutions that are members of ECOG-ACRIN.

Principal Investigator Committee Welcomes New Investigators

At its May 2013 meeting, the Principal Investigator (PI) Committee approved Keren Sturtz, MD, medical oncologist, as the new designated PI for the Colorado Cancer Research Program, replacing Eduardo Pajon, MD.

joseph leach

The PI Committee also approved Joseph W. Leach, MD, medical oncologist, as the new designated PI for the Metro-Minnesota Cancer Community Oncology Program, replacing Patrick J. Flynn, MD.

In reporting the news about changes in the status of trials conducted by ECOG-ACRIN and PrECOG, LLC, an editorial decision was made to present this information on a newsletter-by-newsletter basis. All trial status updates listed below have occurred since the May 2013 issue of the ECOG-ACRIN newsletter.

Trial Activations

Head and Neck - E1311

A Randomized, Placebo Controlled Phase II Trial of Afatinib (BIBW2992) as Adjuvant Therapy Following Chemoradiation in Patients with Head and Neck Squamous Cell Carcinoma at High Risk of Recurrence

Chair: Christine H. Chung, MD (Johns Hopkins University)

Co-Chair: Missak Haigentz, Jr, MD (Albert Einstein College of Medicine of Yeshiva University)

Accrual goal: 108

Date activated: July 11, 2013

Projected completion: February 2016

Head and Neck - E3311

Phase II Randomized Trial of Transoral Surgical Resection followed by Low-dose or Standard-dose IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer

Chair: Robert L. Ferris, MD, PhD (University of Pittsburgh Cancer Institute)

Co-Chair: Harry Quon, MD, MS (Johns Hopkins University)

Accrual goal: 377

Date activated: July 9, 2013

Projected completion: October 2016

Trial Re-activations

Leukemia - E2905

Randomized Phase III Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment with Lenalidomide (Revlimid) Alone and in Combination with Epoetin Alfa (Procrit�) in Subjects With Low- or Intermediate-1 Risk MDS and Symptomatic Anemia

E2905 re-opened to accrual on June 6, 2013 after the National Cancer Institute approved an amendment allowing new patients to commercially receive recombinant human erythropoietin (epoetin alfa or Procrit�). The study was previously suspended to accrual on December 31, 2012.

Trial Closures

Gynecologic - GOG-0233 / ACRIN 6671

Utility of Preoperative FDG-PET / CT Scanning Prior to Primary Chemoradiation Therapy to Detect Retroperitoneal Lymph Node Metastasis in Patients with Locoregionally Advanced Carcinoma of the Cervix (IB2, IIA ≥ 4 CM, IIB-IVA) or Endometrium (Grade 3 Endometrioid Endometrial Carcinoma; Serous Papillary Carcinoma, Clear Cell Carcinoma, or Carcinosarcoma (Any Grade); and Grade 1 or 2 Endometrioid Endometrial Carcinoma with Cervical Stromal Involvement Overt in Clinical Examination or Confirmed by Endocervical Curettage)

Date closed: June 21, 2013

Thoracic - E3508

A Phase II Randomized Trial of Paclitaxel, Carboplatin, Bevacizumab with or without IMC-A12 in Patients with Advanced Non-Squamous, Non-Small Cell Lung Cancer

Date closed: June 28, 2013

Breast - ACRIN 6691

Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging (DOSI)

Date closed: June 30, 2013

Gynecologic - GOG-0262 / ACRIN 6695

A Phase III Trial of Every-3-Weeks Paclitaxel versus Dose Dense Weekly Paclitaxel in Combination with Carboplatin with or without Concurrent and Consolidation Bevacizumab (NSC #704865, IND #113912) in the Treatment of Primary Stage II, III, or IV Epithelial Ovarian, Peritoneal or Fallopian Tube Cancer and ACRIN 6695: Perfusion CT Imaging to Evaluate Treatment Response in Patients Participating in GOG-0262

Date closed: July 1, 2013

Trial Suspensions

Breast - E3108

A Phase II Prospective Trial Correlating Progression Free Survival with CYP2D6 Activity in Patients with Metastatic Breast Cancer Treated with Single Agent Tamoxifen

Date suspended: June 21, 2013

Accrual was suspended for further evaluation of feasibility, as planned in the protocol.

Trial Approvals

Lymphoma - E4412

A Phase I Study with an Expansion Cohort of the Combination of Ipilimumab and Brentuximab Vedotin in Patients with Relapsed/Refractory Hodgkin Lymphoma

Date approved: June 24, 2013

Anticipated activation: Mid September 2013

In previous newsletters, we reported several trial approvals, and some of these trials still await activation. As a service to our readers, we will continue to list these trials in our newsletters until they reach their activation date.

Myeloma - E1A11

Randomized Phase III Trial of Bortezomib, Lenalidomide and Dexamethasone (VRd) Versus Carfilzomib, Lenalidomide and Dexamethasone (CRd) Followed by Limited or Indefinite Lenalidomide Maintenance in Patients with Newly Diagnosed Symptomatic Multiple Myeloma

Date approved: November 14, 2012

Anticipated activation: Early September 2013

Breast - Alliance A011104 / ACRIN 6694

Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women with Breast Cancer

Date approved: April 1, 2013

Date pre-activated: July 22, 2013

Anticipated activation: Mid September 2013

Lymphoma - E1412

Randomized Phase II Open Label Study of Lenalidomide R-CHOP (R2CHOP) vs RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) in Patients with Newly Diagnosed Diffuse Large B Cell Lymphoma
Date approved: May 3, 2013

Date pre-activated: June 14, 2013

Anticipated activation: Late August 2013

Thoracic - E2512

A Phase I / Randomized Phase II Study of Docetaxel with or without AZD4547 in Recurrent FGFR1-Amplified Squamous Non-Small Cell Lung Cancer

Date approved: September 27, 2012

Anticipated activation: Mid August 2013

Trial Completion Date Modifications

Melanoma - E2607

A Phase II Trial of Dasatinib in KIT-Positive Patients with Unresectable Locally Advanced or Stage IV Mucosal, Acral and Vulvovaginal Melanomas

Completion date: Originally March 2013; now March 2017

Melanoma - E3611

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

Completion date: Originally July 2013; now December 2014

Gynecologic - ACRIN 6682

Phase II Trial of 64Cu-ATSM PET/CT in Cervical Cancer

Completion date: Originally June 2013; now December 2014

Gastrointestinal - ACRIN 6690

A Prospective, Multicenter Comparison of Multiphase Contrast-Enhanced CT and Multiphase Contrast-Enhanced MRI for Diagnosis of Hepatocellular Carcinoma and Liver Transplant Allocation
Completion date: Originally July 2013; now December 2015

July 2013

In This Issue

From the Group Co-Chairs

Young Investigator Symposium

Scientific Committee Appointments

Scientific Event on Disparities

Principal Investigators Named

Trial Activations

Trial Re-activations

Trial Closures

Trial Suspensions

Trial Approvals

Trial Completion Date Modifications

Group Meeting Information

New Trial Education Pages

E1512 Trial Spotlight

Spring 2013 Meeting Sponsors

Latest Group Meeting Information

The Fall 2013 ECOG-ACRIN Group Meeting will take place in Hollywood, FL from Thursday morning, November 14 through Saturday evening, November 16, 2013.

Online registration for the upcoming meeting will open in late August.

Attendees: Please remember the Thursday to Saturday format when making travel plans.

Save the Dates

The Group Meeting schedule is now set through 2015. Visit the Group Meetings section of the ECOG-ACRIN website for details.

Now Posted:

New Educational Materials at ECOG-ACRIN.org

Select the trial number below to go directly to the material:

E3311

E2211

E1Z11