Philip J. DiSaia, MD - Group Chair Larry J. Copeland, MD - Group Vice Chair

G Y N E C O L O G I C O N C O L O G Y G R O U P

NewsletterF A L L 2 0 1 2

The multiple changes mandated by the

National Cancer Institute (NCI) for

Cooperative Group Research has created

a flurry of activity. A brief update on

some of the activity is as follows:

The Fundraising Opportunities

Announcement (FOA) for the Operations

Grant and the Biostatistics/Data

Management Grant were among the five

recently-released FOAs. Plans for a joint

Operations Center Grant by GOG, RTOG

and NSABP are moving along with a plan

to form a new 501 (c) 3 called NRG,

which would manage the fiscal aspects

of the grant, and gradually unify those

aspects of our organization that would

benefit from merging efforts. The plan is

to have NRG begin small and grow with

time, meanwhile NRG would apply for

funding for all three satellite operation

centers, and be under the direction of

three multi-PIs who currently preside as

Group Chairs. Attorneys have been

engaged to create the legal entity and

corresponding bylaws.

A similar combination of our

biostatistics/data management

centers will be in response to a separate

FOA. The directors of the three current

centers are discussing structure with

three co-PI’s but the details are

ADMINISTRATIVE OFFICES

Four Penn Center

1600 JFK Boulevard, Suite 1020

Philadelphia, PA 19103

215-854-0770

STATISTICAL & DATA CENTER

Roswell Park Cancer Institute

Elm & Carlton Streets

Buffalo, NY 14623

716-845-5702

FINANCE & DEVELOPMENT

2127 Espey Court

Suite 100

Crofton, MD 21114

410-721-7126

Update: Plans for NRG are “Moving Along”

not yet available.

There also will be a translational science

FOA with very modest funding. Plans for

this are now under discussion. The bio

repository grants will be reduced in

number under a separate FOA and this

re-organization is currently underway.

There are multiple changes happening

simultaneously and more details will be

forthcoming. I am pleased that our three

Groups with very different areas of

influence and past histories are coming

together in a very collegial manner. It has

been a pleasure working with both RTOG

and NSABP.

The GOG would like to thank its

newsletter sponsors

GlaxoSmithKline

Genentech

Pfizer Oncology

Precision Therapeutics, Inc.

Sanofi-Aventis

INSIDE THIS ISSUE

Chairman’s Corner

1

Protocol Department

2

“Chasing The Cure”

4rs

Young Investigators

Recipients

7

Philip J. DiSaia, MD - Group Chair

Chair’s Corner Philip J. DiSaia, MD

Abbott Oncology

Advaxis

AltheaDX

Amgen Oncology

Astellas Oncology

Boehringer Ingelheim

Bristol-Myers Squibb

Celgene Corporation

Cell Therapeutics, Inc.

Champions Oncology

Egen, Inc.

Eisai Oncology

MiraDx

Morphotek, Inc.

Novartis Pharmaceuticals

OvaGene Oncology

OxiGENE, Inc.

Pfizer Oncology

Precision

Therapeutics, Inc.

Regeneron

Pharmaceuticals

Sanofi-Aventis

VentiRx

Eli Lilly & Company

Endocyte

Genentech BioOncology

GlaxoSmithKline

Janssen Products, LP

The National Cancer Institute (NCI) has mandated that

all CTEP-sponsored trials be submitted in a new format

to include hyperlinks. The links will allow electronic

navigability between all sections listed in the table of

contents, between references in the body of the

protocol and the bibliography. It will also link section

references to that section within the protocol itself.

It was explained that the electronic navigability of

these hyperlinked documents will enable CTEP to

review submissions electronically and will no longer

require printing of documents. They will not maintain

hard copy files, which benefits the environment and

requires less storage.

The FDA will require all CTEP submissions to be in this

new format by 2015 and the Cooperative Groups

have been mandated to comply as of October 1, 2012.

Amendments will require a Summary of Changes to be

the first page of the protocol and a separate Summary

of Changes as the first page of the informed consent.

The Summary of Changes will be in a table format and

will provide hyperlinks to the revised area in the

protocol or informed consent document. We will

maintain the twelve section protocol format.

What this will mean for the institutions is that when

amendments are broadcast on the GOG website, they

will appear in this new format with the change memo

as the first page of the protocol. All appendices will

appear at the end of the protocol document. The

consent form will continue to be a separate

document and the first page of the consent will be

the Summary of Changes for the consent. The

hyperlinks will be live and may help facilitate IRB

review of amendments with the benefit of electronic

navigability.

As amendments to active and closed studies become

necessary, they will be submitted to CTEP in this new

format - and when approved - sites should expect to

see future amendments broadcast in this new format.

For now, this applies to CTEP-sponsored trials only. DCP

trials are not yet required to be submitted in this

format. Over time we would expect to handle all trials

in the same way.

A New Look for GOG Protocols

Protocol Department

VTX-2337

- Novel, small molecule toll-like receptor 8 (TLR8) agonist

- Stimulates the innate immune system

- Synergistic with Doxil® in ovarian cancer model (Dr. George Coukos, University of Pennsylvania)

- Subcutaneous dosing

CLINICAL DEVELOPMENT

- Safety & tolerability in combination with Doxil® established (GOG-9925)

- Important proof-of-concept evaluation with overall survival as primary endpoint

* Doxil® will be supplied for eligible study participants through May 2013

1301 Second Avenue, Suite 2800, Seattle WA 98101 Tel 206.689.2259 clinicalaffairs@ventirx.com

GOG-3003G O G Pa r t n e r s S t u d y No w A c t i v e

Randomized, placebo-controlled phase 2 protocol comparing Doxil® (PLD) versus Doxil® (PLD) + VTX-2337 in platinum-resistant ovarian cancer*

High Priority Protocol9 Membership Points per Patient

TLR8 agonist directly stimulates myeloid dendritic cells (mDC) and enhances innate and adaptive immune responses within tumors

Targeting the Tumor Microenvironment

When asked earlier this year about her

expectations for the Fall 2012 “Chasing

The Cure” 5k race and 1 mile walk, Terra

Draper, race founder and coordinator,

sheepishly replied: “Oh, I’d love to double the

number of participants and donations to

the GOG.”

Be careful what you wish for,

Terra.

For the third-consecutive year,

the town of Sturgis, Michigan

hosted the annual “Chasing The

Cure” event. What started as a

grass-roots effort three years ago to help raise

awareness and funds for GOG research into ovarian

cancer, has quickly become a well-recognized event

in the state of Michigan. This is all thanks to Terra’s

efforts.

“What a year ... I don’t know why but I am still just

amazed by the turnout and support and help that we

receive with our town being so small,” Terra said.

This year, close to 350 participants gathered on a

picturesque day in late September – that is close to

twice the amount (190) of participants from 2011. Not

only did the number of participants increase, but so did

the number of sponsors and event donors who

supplied food, drinks, signs and

raffle prizes.

“We even had somebody from a local tv

station, News 3, here at the race, so I know we did our

job on getting the word out,” she said.

Thanks to the generosity of race

participants and donors, the event

raised over $10,000, which was

donated to GOG’s New Horizons GYN

Cancer Research Fund. Terra

organized the first race over three

years ago. She conceived the event

as a way to help raise awareness

about ovarian cancer – the disease

that her aunt, Joan Dykstra, is battling. Terra dedicated

the race to her aunt.

The GOG would like to express its thanks to Terra,

the race participants and sponsors for their

generosity to help support research for eradicating this

devastating disease.

“Chasing The Cure” One Race at a Time

What a year ...

I don’t know why but I am still

just amazed by the turnout

and support ...

”

“

Special “Thank You!”Terra Draper and the GOG would like to express

their appreciation to Genentech BioOncology for its

sponsorship and support of

the 2012 “Chasing The Cure”

5k race and 1 mile walk.

Race Participants

Kim AdamsLaura AdamsWendy AndrewsSean AndrewsKim AnnisJames ArverDebbie BainbridgeBobbi Jo BainbridgeSara BakerMonte BalyeatPedro BarnalAndrea BarnardJackie BarnardMarty BarnardLaura BarnardKeith BarnesCarrie BaumAdian BaumChloe BaumKayler BeechWendy BeechSandra BellaireAutumn BennettPeg BidlingmeyerCallaway BirdKathryn BirdQuinn BirdDana BlankenshipHarlan BloodHarlie BlumKellie BlumNoelle BorgertDave BowdishMorgan BowersMadison BowersElle BowmanArthur Bowman IIIDebra BrackinsSamantha BrooksKathy BrownAmy BucklinAnnabella BucklinPamela BunceDavid BunceRylie BundyLinda BurnhamBob BurnhamDebbie BurzynskiTammy CainRylee CainTyler CainMcKenzie CainAbdiel CardielCarrigan CarpenterPeg CarrollMichael CarrollAdam CarterRylee CarverCaiden CarverTracy CarverHeather CashRuth CernyRyleigh CollinsCharles CollinsPenny ConklinMike ConklinKatie ConorJeff CrueaKristine CrueaTyler CrueaJustine CulliferCleo CurrierBecky DaltonSusan DaoustPete DarienzoGerald DayharshTaylor DeBoardTim DeBoard

Narusa DeGroffDebbie DoeJerry DowningMarti DowningElizabeth DykstraTerry DykstraJoan DykstraDavid DykstraDiane DykstraBrian DykstraAmeila EarlWendall EichornTami EllisLuanna EvansJennifer FairDelana FarrRhonda FehringMichelle FishRandy FkyleKellie FranksJacob FranksGabe FranksIzzy FranksMike FrostSusanne FrostMegan FryBill FurrDawn GallupDeb GelvinBrooke GeorgeTrevor GermanRay GilbertJoyce GilbertSteven GilbertPamela GilbertElly GilbertCathi GreenDereck GriffinKayla GriffinJeff GriffinHelen GuisingerMary GuldinAnisley GumpJen GumpPreston GumpRenee GuzyPaige Gwathney Sandra Gwathney Penny HackenbergMike HackenbergBrandy HackenbergSara HackmanAmy HackmanEllen HaistKatlin HaistSharon HarkerNecolle HarmonChristine HarperAnthony HarperMary HarrisNicole HaugenCarter HaugenBrennan HaugenRenuka HaugenLucas Haugen Dawn HelmsJessica HempelBrian HenigeScott HeraldKendra HibbsGrace HochstetlerJohn HollarTaylor HopkinsJason HopkinsAlexzandra HullCindy HuverPete HuverAlison IdrissTracey IlerMark Iler

Wendy JenksDawn JohannesPat JonesCheryl JordanTara KanouseBonnie KauffmanLaurie KeeslarFred KeisterPatrick KelleyNate KershnerCathy KibiloskiAlice KielauDerien KleineMatt KleineSheryl KliewerKatelyn KorzinekJenna KozloffKatherine KozloffBeth KreuterAndrew KukJana KyleMargaret LandrumBarb LawsCaril Jo LehmnaSara LewisBarry LindblomKatie LipariCindy LoganAdria LoganRoberta LueggeDiana MacGregoryKelly MallonyAngela MarksNikki MartensenMelissa MasseLindsey MaxwellWendy McCartneyJanelle McGheeHilary McGowanKelcie McGowanMaycie McGowanAnn McInerneyGlenda MelinTraci MelvilleJosh MeyersRuth MillerRoss MillerRick MillerScott MIllerVickie MillerPhil MillerMarjorie MohneyTami MohneyBrenda MooreJennifer MoushegianRonald MullinsRebecca MurphyStacey MusserMichelle MyersBreckon MyersBret MyersJordan MyersRylee MyersAlisha NettlemanAnita NettlemanAdison NettlemanDeb NeydonAmy O'ConnorHope OggHeather OrbeckJasson OrbeckJohanna Orca-

HandysideCarla OsbornJennifer OstermanJessica OverholtLaurel OwensSarah OwsleyValary PackerBernice Packer

Christine PaulinScott PaulinHarlie PaulinCharity PaulinDora PaytonAnthony PercivalKris PhillipsKellie PoortengaMike PoortengaKyle PoortengaKyle RayTera ReurinkMary ReurinkLois RhodesColtin RichardsRobyn RichardsonBrian RichardsonPete RichardsonCheryl RiderKelly RiderDebra Ritsema-

StaffordJo RobinsonEric RueppelGarrett RussellChristian RussellJessica RutenbarJan SageStephanie SageRagan SavaraAnnette SaxmanHeather SaxmanJanice SaxmanChris SchererKeith SchultzEmily SchultzKalyn SchultzLindsey ShiveKelly SikorskiBarbara SkinnerJamie SloneBobbi Jo SmithChristi SmithJamie StacyKara StacyConnor StacyAcie StanfillBrian StearsDenver StevensKen StoneElaine StrilerMatthew SutterKrista SwaffordEmily SylvesterMandi TaylorAmy TaylorKathy ThortonMaida TirginsGustavo TovarHalli TowersSara TrattlesLori TrineHunter TrineLavera TroyerJessilyn TroyerBrooke TroyerMyah TroyerMelissa Turner-

ChambersHeidi VanNestAshley VanVorstGayle VanVorstAaron VanVorstChloe VickersLisa VickersAutumn VonVorstRonald WaiteSandi WaldronStefanie WallRobert Watson

Cindy WeidermanDean WellsMelinda WestAmanda WestBianca WestJulie WhiteKathy WidauWilma WilderBrandan Williamson Dawn WilsonChristina Winter-YorkJulie WoodAlexis WoodLori WriteValerie WuoriDanielle WuoriShannon WyattChristi YoungTeresa YunkerAshley ZimmermanSara Zimmerman

SponsorsAdvantage Water

ServiceArmstrong

InternationalBarnell CarpetBJ RestaurantBlack Gold PotatoesBob's Bait and

TackleBofaBogan ConcreteBoland TireBoundary Waters

Coffee and CaféBowersox FlooringBrown's AutoBurr Oak Tool IncBylers FarmC L H Construction

and ConcreteCamburn's Central FloristCentral Meat

MarketChina GardenCitizensCorner CaféCottin's CruiserRV

Dawne Colbart DeBoard

Chiropractic, PCDoyle Community

CenterDr. ClarkDraper ConstructionDreams Come TrueDRV LLCEdward JonesExpress Nutrition Eye Care WestFieasta MexicanaFit ZoneGayle CunninghamGilbert's ShellGOGGrandpa and

Grandma DykstraGrandpa and

Grandma GilbertGreen Valley

CampgroundGreen Valley Golf

CourseHackmanHaircrafters Barber

ShopHamlin's Motorcycle

CenterHarker ExcavatingHeadlinesInquire PartnersInspire Hair SalonIntuitive Designs LLCIt's A Dog's WorldJack's AutoJaycoJohn Polzin, DDSJohn TateK and K TruckingKrogerLaVera TroyerLeanne BarnellLinda GrossLogan ExcavationLowry’s BooksLudders Cleaners Luttmann Precision

Mold, IncMagic MomentsMandi Taylor

Maria's Metrex BarsMeyers Service

StationMichiana SnaxMingus PetroluemMike and Catherine

Thomasma Nancy RichardsonOakleaf FinancialPanachePat QuirinPat WilsonPepsi of ColdwaterPostnetRandall and Claudia

Pahls Red Rose FlooringSave-a-lotSportsarama Squirt IrrigationStacy Schwenk -

Re/Max EliteGroup

Stafford and SmithLynn Reed - State

Farm InsuranceSturgis Auto BathSturgis Electric

MotorSturgis HospitalSturgis JournalSturgis Trophy

HouseTC ApplianceTelemarkThe King's ClosetThurston WoodsTravel with

the Magic:Amy BladesTammy Cain

Trios DeliTuffy MufflerVogtsW. Wyatt Custom

Construction andSeamless Gutters

WalmartWillersYesh MetalZeta Metzger

Thank You, Sturgis!The GOG and Terra Draper would like to thank the following race participants and donors for their help and generosity:

On September 22, the GOG donated three of it’s own “Steppin’

Out” charms to participants of the National Ovarian Cancer

Coalition, Dallas/Ft. Worth Chapter’s 12th Anniversary

Run/Walk to Break the Silence on Ovarian Cancer. The event

benefits the National Ovarian Cancer Coalition education and

benefit programs nationwide.

On behalf of GOG, Patient Advocate Debbie Miller awarded the

charms to event participants: Erin Contreras, Jennifer Carlson

and Debbie Clifford (picture above with Debbie Miller, left).

GOG awards bracelets to 2012 Ovarian

Cancer Awareness Run/Walk participants

New Horizons GYN Cancer Research Fund

Jack and Jan Kellner Memorial Fund

Bette L. Stonebraker

Sharon K. Stockman

In Memory of Patricia DuntonBarbara Levesque

In Memory of Holly Hoezee

Kyleigh Hoezee & Friends

DM Stehouwer

In Memory of Beatrice Six

Lynne and Karen Pelkey

Virginia Calega, MD/Highmark

F. Christopher Six

In Memory of Linda Grafton

Anonymous

In Honor of Nelva DystraHohner Funeral Home

Leanne Barnell

Shannon Goodman

Allen and Julie White

Jack and Marlene Vos

Rhonda and James Kraai

Charles Hornick

Allan and Kristi Looman

Ronald and Diana Roskuski

Gene and Shirley Vanrhee

Kathryn Reick

Robert and Mary Beth Vansingel

Brian and Tammera Nelson

Eric Delle

David Dykstra

In Memory of Jean Diane BunceDolores and Jim Potts

In Honor of Jean SpencerJeanine Bogashewicz

In Honor of Lois RhodesRose Rhodes

In Memory of Phyllis Ferancy

Damon and Lindsay Pollock

Sally and Sanford Siegler

David and Lori Hamilton

Brian and Doreen Pant

Anonymous

Nancy Getter

Anonymous

Mary A. Loranger

Jodi and Allan Feldman

Elizabeth and Dick Pompei

Mr. and Mrs. Elmer Popiel

Dennis and Madeline Block

Terry and Alice Lee

Elaine Madansky and

Keith Goldberg

Dan and Andrea Pollock

Kurt and Bonnie Gillen

General DonationEdward and Gladys Ziegler

Foundation

Ovarian Cancer Alliance SW

James and Lois Rhodes

Paula Fracasso and John Francis

Anonymous

The University of Chicago

Laboratory Schools’

Fifth Grade Students,

Families and Teachers

Lisa G. Weber

Geico Philanthropic Foundation

Sharon Day

Anonymous

In Honor of Dr. Mark Greene, NIH/NCI

(For his work and article on

salpingectomy for CRCA

mutation carriers)

Gretchen Owens

New Horizons GYN Cancer Research FundThe GOG would like to thank the following individuals, families and organizations for their generous

contributions to the New Horizons GYN Cancer Research Fund:

GOG’s 85th Semi-Annual MeetingBoston 2012

The Massachusetts State House in Boston(above).

Meeting participants enjoy the reception festivities (below).

Participants listen intently to the

meeting symposium.

Dr. Birrer welcomes everyone to “Bahstan.”

Meeting attendees visit the Exhibit

Hall in between sessions.A “sentry” greets visitors asthey enter the reception.

2013 YOUNG INVESTIGATORAWARD RECIPIENTS

Emily Ko, MDUniversity of North Carolina

Treatment of Advanced or Recurrent Endometrial andCervical Cancer: The Impact of ChemotherapyToxicity and Quality of LifeChanges on Elderly Patients

Prognostic Significance of Ascites in Patients with Advanced Ovarian, FallopianTube and Peritoneal CancersTreated with CytotoxicChemotherapy plus Bevacizumab

James S. Ferriss, MDTemple University School

of Medicine

Young Investigator Awards are sponsored by:

Gynecologic Oncology Group2127 Espey CourtSuite 100Crofton, MD 21114

For the latest news and information, visitwww.gog.org

NON-PROFIT ORGANIZATION

U.S. POSTAGE PAID

CROFTON, MD

PERMIT NO. 19

Friday, January 25, 2013 | 12:00 PM - 1:30 PM | San Diego, CA

This activity is sponsored by Educational Concepts Group, LLC

The target audience for this activity is medical, gynecologic, radiological, and surgical oncologists, oncology pharmacists, and other healthcare professionals caring for patients with ovarian cancer.

A 90-minute CME-certified Luncheon Satellite Symposium to be held in conjunction with the GOG’s Semi-Annual Meeting, immediately following the GOG General Session.

This activity is not part of the official GOG Semi-Annual Meeting.

For Meeting Information and Registration Details Visit www.educationalconcepts.net/gog