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VTX-2337 and Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, TreatmentActive18 and overPharmaceutical / IndustryGOG-3003
NCT01666444

Trial Description

Summary

The purpose of this study is to compare the overall survival of patients treated with VTX-2337 + pegylated liposomal doxorubicin (PLD) versus those treated with PLD alone in women with recurrent or persistent, epithelial ovarian, fallopian tube or primary peritoneal cancer.

VTX-2337, a small molecule agonist of Toll-like Receptor 8 (TLR8), activates multiple components of the innate immune system and is being developed as a novel therapeutic agent for use in oncology. Experimental data obtained in an animal model of ovarian cancer supports the combination of VTX-2337 with PLD. In this model, the combination of VTX-2337 and PLD resulted in a significant reduction in tumor growth compared to either agent alone and an increase in the number of T lymphocytes infiltrating the tumor. The combination of PLD and VTX-2337 has been tested in a small number of women with ovarian cancer in a Phase 1b study and appears to be generally well-tolerated.

Further Study Information

OBJECTIVES

Primary Objective:

To compare the overall survival (OS) of patients treated with VTX-2337 + PLD versus those treated with PLD alone in women with recurrent or persistent, epithelial ovarian, fallopian tube or primary peritoneal cancer.

Secondary Objectives:

  • To compare the progression-free survival (PFS) between the two treatment groups using Immune-Related Response Evaluation Criteria In Solid Tumors (irRECIST).
  • To compare the nature, frequency and severity of drug-related adverse events (AEs) between the two treatment groups.

Exploratory Objectives:

  • To compare the best overall response rate (ORR) and duration of response (based on the probability of being in response function [PBRF]) between the two treatment groups using irRECIST.
  • To compare the disease control rate (DCR) between the two treatment groups using irRECIST.
  • To assess the impact of immune status and response on the clinical effects (OS, PFS, DCR, ORR, PBRF, AEs) of study treatment.
  • To assess the effect of TLR8 polymorphisms on the clinical effects (OS, PFS, DCR, ORR, PBRF, AEs) of study treatment.
  • To assess the effect of immune cell subsets, as measured by immunohistochemistry in primary tumor tissue (e.g. immune score), on the clinical effects (OS, PFS, DCR, ORR, PBRF, AEs) of study treatment.

OUTLINE:

This is Phase 2 multicenter clinical study to evaluate the efficacy and safety of the combination of VTX-2337 + PLD compared to PLD + Placebo.

The dosing schedule will be the same for both treatment arms, and will be based on a 28-day cycle. The starting dose schedule is PLD on Day 1 plus VTX-2337 or placebo on Day 3, Day 10, and Day 17 for the first 4 cycles. Starting with cycle 5, the dose regimen will be PLD on Day 1 plus VTX-2337 or placebo on Day 3.

Blood samples are collected periodically during cycle 1 for pharmacodynamics, pharmacogenomics, and other research studies.

Patients will receive therapy until disease progression based on Immune-Related RECIST or until adverse effects prohibit further therapy. Following treatment completion, all patients will be followed with physical exams and histories every three months for the first two years, and then every six months for the next three years, and then

Eligibility Criteria

Inclusion Criteria:

1. Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.

2. Patients with the following histologic cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial adenocarcinoma, transitional cell carcinoma, malignant Brenner's tumor or adenocarcinoma not otherwise specified.

3. Patient must have measurable disease as defined by RECIST 1.1.

4. Patients must have received treatment with a platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, consolidation, non-cytotoxic agents or extended therapy administered after surgical or non-surgical assessment.

Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease.

Patients are allowed to have received, but are not required to have received, biologic/targeted therapy (e.g., bevacizumab and/or PARP inhibitor) as part of their primary treatment regimen or for management of recurrent or persistent disease.

5. Patients must have platinum-resistant disease, defined as having a platinum-free interval (PFI) of < 12 months after first- or second-line platinum-based chemotherapy, or having disease progression while receiving second-line platinum-based chemotherapy.

6. Patients must have adequate bone marrow, renal, hepatic, and neurologic functions as defined by the following:

  • Bone marrow function: absolute neutrophil count (ANC) ≥ 1,500/mm3. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets ≥ 100,000/mm3. Hemoglobin ≥ 9 g/dL.
  • Renal function: creatinine ≤ 1.5 x institutional upper limit normal (ULN).
  • Hepatic function: bilirubin < 1.2 mg/dL, SGOT (AST) and SGPT (ALT) ≤ 3.0 x ULN and alkaline phosphatase ≤ 2.5 x ULN.

7. Patients must have recovered from effects of recent surgery, radiotherapy or chemotherapy:

  • Patients should be free of active infection requiring parenteral antibiotics.
  • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration. Continuation of hormone replacement therapy is permitted.
  • Any other prior therapy directed at the malignant tumor, including chemotherapy, biologic/targeted agents and immunologic agents, must be discontinued at least three weeks prior to registration.
  • Any prior radiation therapy must be completed at least four weeks prior to registration.

8. Patients must have a GOG performance status of 0 or 1.

9. Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.

10. Patients must meet the entry requirements and undergo the baseline procedures.

11. Patients must have signed an IRB-approved informed consent form and authorization permitting release of personal health information.

Exclusion Criteria:

1. Patients who have had treatment with VTX-2337, doxorubicin, PLD, or any other anthracycline.

2. Patients who have received an investigational agent < 30 days prior to registration.

3. Patients who have received oral or parenteral corticosteroids < 2 weeks prior to registration or who require ongoing systemic immunosuppressive therapy for any reason.

4. Patients with active autoimmune disease. "Active" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.

5. Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of the other malignancy being present within the last three years.

6. Patients who have received prior radiotherapy OTHER THAN for the treatment of ovarian, fallopian tube or primary peritoneal cancer within the last three years are excluded.

7. Patients who have received prior chemotherapy OTHER THAN for the treatment of ovarian, fallopian tube or primary peritoneal cancer within the last three years are excluded.

8. Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.

9. Patients with clinically significant cardiovascular disease.

10. Patients who are pregnant or nursing.

11. Patients under the age of 18.

12. Patients with clinical symptoms or signs of gastrointestinal obstruction and/or who require parenteral hydration or nutrition.

Trial Contact Information

Trial Lead Organizations/Sponsors

VentiRx Pharmaceuticals, Incorporated

Gynecologic Oncology Group

Bradley J. MonkStudy Chair

Bradley J. Monk, MDPh: (602) 406-7730
  Email: Bradley.Monk@chw.edu

Trial Sites

U.S.A.
Arizona
  Phoenix
 St. Joseph's Hospital and Medical Center
 Catherine Newitt, RN Ph: 602-406-2141
  Email: Catherine.Newitt@dignityhealth.org
 Bradley Monk, MDPrincipal Investigator
Arkansas
  Little Rock
 Winthrop P. Rockefeller Cancer Institute - University of Arkansas
 Shanna Fetters Ph: 501-686-8274
  Email: fettersfhanam@uams.edu
 Kristin Zorn, MDPrincipal Investigator
California
  Burbank
 Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
 Veronica Hudson, CCRP Ph: 818-748-4778
  Email: veronica.hudson@providence.org
 Richard Friedman, MDPrincipal Investigator
  Hayward
 Kaiser Permanente Medical Center - Hayward
 Lauren Tkachenko Ph: 510-784-6040
  Email: lauren.c.tkachenko@kp.org
 Desiree Goldstein Ph: 707-651-2797
  Email: Desiree.Goldstein@kp.org
 Tatjana Kolevska, MDPrincipal Investigator
  Long Beach
 Todd Cancer Institute at Long Beach Memorial Medical Center
 Elizabeth Lavelle Ph: 562-933-7866
  Email: elavelle@memorialcare.org
 Robert Bristow, MDPrincipal Investigator
  Oakland
 Kaiser Permanente Medical Center - Oakland
 Christine Macaraig Ph: 510-752-7495
  Email: christine.c.macraig@kp.org
 Desiree Goldstein Ph: 707-651-2797
  Email: Desiree.Goldstein@kp.org
 Tatjana Kolevska, MDPrincipal Investigator
  Roseville
 Kaiser Permanente Medical Center
 Lauri Beltrand Ph: 916-474-2172
  Email: lauri.beltrand@kp.org
 Desiree Goldstein Ph: 707-651-2797
  Email: Desiree.Goldstein@kp.org
 Tatjana Kolevska, MDPrincipal Investigator
  Sacramento
 Kaiser Permanente Medical Center - Sacramento
 Souphata Phothong Ph: 916-973-5840
  Email: Souphata.Phothong@kp.org
 Desiree Goldstein Ph: 707-651-2797
  Email: Desiree.Goldstein@kp.org
 Tatjana Kolveska, MDPrincipal Investigator
 Sutter Cancer Center
 Clara Dunn Ph: 916-454-6539
  Email: dunncm@sutterhealth.org
 Stacy D'Andre, MDPrincipal Investigator
  San Francisco
 Kaiser Permanente Medical Center - San Francisco Geary Campus
 Eleanor Dekelaita Ph: 415-833-2495
  Email: eleanor.c.dekelaita@kp.org
 Desiree Goldstein Ph: 707-651-2797
  Email: Desiree.Goldstein@kp.org
 Tatjana Kolevska, MDPrincipal Investigator
  San Jose
 Kaiser Permanente Medical Center - Santa Teresa
 Vanessa Suhama Ph: 408-972-6736
  Email: vanessa.suhama@kp.org
 Desiree Goldstein Ph: 707-651-2797
  Email: Desiree.Goldstein@kp.org
 Tatjana Kolevska, MDPrincipal Investigator
  Santa Clara
 Kaiser Permanente Medical Center - Santa Clara Homestead Campus
 Tida Tanti Ph: 408-851-4270
  Email: tida.x.tanti@kp.org
 Desiree Goldstein Ph: 707-651-2797
  Email: Desiree.Goldstein@kp.org
 Tatjana Kolevska, MDPrincipal Investigator
  South San Francisco
 Kaiser Permanente Medical Center - South San Francisco
 Paige Xu Ph: 650-742-3939
  Email: paige.xu@kp.org
 Desiree Goldstein Ph: 707-651-2797
  Email: Desiree.Goldstein@kp.org
 Tatjana Kolevska, MDPrincipal Investigator
  Stanford
 Stanford Cancer Center
 Sharanya Ramasubramanian Ph: 650-723-0622
  Email: sharanya@stanford.edu
 Jonathan Berek, MDPrincipal Investigator
  Vallejo
 Kaiser Permanente Medical Center
 Denise Townzen Ph: 707-651-4194
  Email: denise.m.townzen@kp.org
 Desiree Goldstein Ph: 707-651-2797
  Email: Desiree.Goldstein@kp.org
 Tatjana Kolevska, MDPrincipal Investigator
  Walnut Creek
 Kaiser Permanente Medical Center - Walnut Creek
 Vicky Shelton Ph: 925-295-5372
  Email: vicky.y.shelton@kp.org
 Desiree Goldstein Ph: 707-651-2797
  Email: Desiree.Goldstein@kp.org
 Tatjana Kolevska, MDPrincipal Investigator
Colorado
  Aurora
 University of Colorado Cancer Center at UC Health Sciences Center
 Robyn Swing Ph: 720-848-0607
  Email: robyn.swing@ucdenver.edu
 Sid McIntosh Ph: 720-848-0681
  Email: sidney.mcintosh@ucdenver.edu
 Susan Davidson, MDPrincipal Investigator
Connecticut
  Hartford
 Helen and Harry Gray Cancer Center at Hartford Hospital
 Karen Cuddy Ph: 860-545-5361
  Email: karen.cuddy@hhchealth.org
 Danytza Ward Ph: 8605455371
  Email: Danytza.Ward@hhchealth.org
 Amy Brown, MDPrincipal Investigator
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Carla Mancini, RN Ph: 860-714-5449
  Email: cmancini@stfranciscare.org
 Philip J. Stella, MDPrincipal Investigator
  New Britain
 George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
 Siobhan Reilly Ph: 860-224-5900 Ext.6718
  Email: sreilly@thocc.org
 Sara Putala Ph: 8602245660
  Email: sara.putala@hhchealth.org
 James Hoffman, MDPrincipal Investigator
  New Haven
 Yale - New Haven Hospital
 Lisa Baker, RN Ph: 203-785-6398
  Email: lisa.baker@yale.edu
 Alessandro Santin, MDPrincipal Investigator
Florida
  Orlando
 M.D. Anderson Cancer Center at Orlando
 Holly Forde Ph: 321-843-7293
  Email: holly.forde@orlandohealth.com
 Veronica Schimp, DOPrincipal Investigator
  St. Petersburg
 Women's Cancer Associates
 Tabetha Swartz Ph: 727-826-0792
  Email: tswartz@WomensCareFL.com
 James LaPolla, MDPrincipal Investigator
Georgia
  Atlanta
 Northside Hospital Cancer Center
 Qun Zeng Ph: 404-845-5053
  Email: qun.zeng@northside.com
 Guilherme Cantuaria, MDPrincipal Investigator
  Augusta
 Georgia Regents University
 Steven McKinnon, RN Ph: 706-721-5557
  Email: smckinno@gru.edu
 Sharad Ghamande, MDPrincipal Investigator
  Gainesville
 Northeast Georgia Medical Center
 Angela Smith
  Email: angela.smith@nghs.com
 Andrew Green, MDPrincipal Investigator
  Macon
 Central Georgia Gynecologic Oncology
 Nikki Musselwhite, RN Ph: 478-633-2152
  Email: musselwhite.nikki@mccg.org
 Julie Gioscio, RN Ph: 478-633-1738
  Email: gioscio.julie@mccg.org
 Frederick Schnell, MDPrincipal Investigator
  Savannah
 Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
 Patricia Sharpe Ph: 912-350-8183
  Email: Sharppa1@memorialhealth.com
 James Burke, II, MDPrincipal Investigator
 St. Joseph's - Candler Gynecologic Oncology
 Joni Shortt, RN Ph: 912-819-5748
  Email: shorttj@sjchs.org
 William E Richards, MDPrincipal Investigator
Hawaii
  Honolulu
 Kapiolani Medical Center for Women and Children
 Nina Bermudez Ph: 808-983-6090
  Email: nbermudez@cc.hawaii.edu
 Michael Carney, MDPrincipal Investigator
Illinois
  Chicago
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Rachel Bers Ph: 312-472-5726
  Email: r-bers@northwestern.edu
 Julian Schink, MDPrincipal Investigator
 Rush Cancer Institute at Rush University Medical Center
 Lois Winkelman Ph: 312-942-2417
  Email: lois_a_winkelman@rush.edu
 Alfred S. Guirguis, MDPrincipal Investigator
  Hinsdale
 Sudarshan K. Sharma, MD, LTD
 Peg Gregus, RN Ph: 630-856-6757
 Sudarshan K. Sharma, MDPrincipal Investigator
  Urbana
 Carle Cancer Center at Carle Foundation Hospital
 Carly Halberstadt Ph: 217-383-4011
  Email: carly.halberstadt@carle.com
 Maria Grosse-Perdekamp, MDPrincipal Investigator
Indiana
  Indianapolis
 Indiana University Melvin and Bren Simon Cancer Center
 Jennifer Vinters Ph: 317-944-2654
  Email: jmvinter@iupui.edu
 Jeanne Schilder, MDPrincipal Investigator
 St. Vincent Gynecologic Oncology at St. Vincent Oncology Center
 Shirley Morrison Ph: 317-415-6747
  Email: samorri1@stvincent.org
 Gregory P. SuttonPrincipal Investigator
Iowa
  Ames
 McFarland Clinic, PC
 Janet Mannetter Ph: 515-239-2621
  Email: mannetter@mgmc.com
 Joseph Merchant, MDPrincipal Investigator
  Iowa City
 Holden Comprehensive Cancer Center at University of Iowa
 Sharon Stockman Ph: 319-356-2015
  Email: sharon-stockman@uiowa.edu
 David Bender, MDPrincipal Investigator
Kansas
  Westwood
 University of Kansas Hospital - Westwood Campus
 Marilyn Labinski Ph: 913-588-4254
  Email: mlabinski@kumc.edu
 Julia Chapman, MDPrincipal Investigator
Maine
  Scarborough
 Maine Medical Partners Women's Health
 Diane Allen Ph: 207-396-7069
  Email: allend2@mmc.org
 Christopher Darus, MDPrincipal Investigator
Maryland
  Baltimore
 Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
 Judy Bosley Ph: 410-601-4714
  Email: jbosley@lifebridgehealth.org
 Mark Miller, DOPrincipal Investigator
 Greater Baltimore Medical Center Cancer Center
 Rennie Twigg Ph: 443-849-3051
  Email: rtwigg@gbmc.org
 Paul Celano, MDPrincipal Investigator
 Greenebaum Cancer Center at University of Maryland Medical Center
 Michele Besche Ph: 410-328-8610
  Email: mbesche@umm.edu
 Sarah Temkin, MDPrincipal Investigator
 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 Judy Murray Ph: 410-955-4044
  Email: jmurra33@jhmi.edu
 Deborah Armstrong, MDPrincipal Investigator
Massachusetts
  Burlington
 Lahey Hospital & Medical Center
 Joyce Pelletier Ph: 781-744-3647
  Email: Joyce.E.Pelletier@lahey.org
 Corrine Zarwan, MDPrincipal Investigator
  Worcester
 University of Massachusetts Memorial Healthcare
 Annie Marcelin Ph: 508-334-1180
  Email: annie.marcelin@umassmemorial.org
 Susan Zweizig, MDPrincipal Investigator
Michigan
  Ann Arbor
 Saint Joseph Mercy Cancer Center
 Amy Liles, RN Ph: 734-712-5394
  Email: lilesj@trinity-health.org
 Philip J. Stella, MDPrincipal Investigator
  Battle Creek
 Bronson Battle Creek
 Connie Szczepanek Ph: 616-391-1230
  Email: connie.szczepanek@grcop.org
 Gilbert DA Padula, MDPrincipal Investigator
  Detroit
 Barbara Ann Karmanos Cancer Institute
 Susan Newell, RN Ph: 313-576-8439
  Email: snewell@med.wayne.edu
 Robert T Morris, MDPrincipal Investigator
 Josephine Ford Cancer Center at Henry Ford Hospital
 Tiffany Pearce Ph: 313-916-1784
  Email: tpearce1@hfhs.org
 Thomas Buekers, MDPrincipal Investigator
  Grand Rapids
 Butterworth Hospital at Spectrum Health
 Connie Szczepanek Ph: 616-391-1230
  Email: connie.szczepanek@grcop.org
 Gilbert DA Padula, MDPrincipal Investigator
 Grand Rapids Clinical Oncology
 Connie Szczepanek Ph: 616-391-1230
  Email: connie.szczepanek@grcop.org
 Gilbert DA Padula, MDPrincipal Investigator
 Gynecologic Oncology of West Michigan
 Amber Door Ph: 616-957-1948
  Email: amdoor242@aol.com
 Gordon Downey, MDPrincipal Investigator
 Lacks Cancer Center at Saint Mary's Health Care
 Connie Szczepanek Ph: 616-391-1230
  Email: connie.szczepanek@grcop.org
 Gilbert DA Padula, MDPrincipal Investigator
  Kalamazoo
 West Michigan Cancer Center
 Wendi Mitchell Ph: 269-382-2500
  Email: wmitchel@wmcc.org
 Raymond Lord, MDPrincipal Investigator
  Muskegon
 Mercy Health Partners - Mercy Campus
 Connie Szczepanek Ph: 616-391-1230
  Email: connie.szczepanek@grcop.org
 Gilbert DA Padula, MDPrincipal Investigator
  Reed City
 Reed City Hospital - Spectrum Health
 Connie Szczepanek Ph: 616-391-1230
  Email: connie.szczepanek@grcop.org
 Gilbert DA Padula, MDPrincipal Investigator
  Traverse City
 Munson Medical Center
 Connie Szczepanek Ph: 616-391-1230
  Email: connie.szczepanek@grcop.org
 Gilbert DA Padula, MDPrincipal Investigator
Minnesota
  Coon Rapids
 Minnesota Oncology Coon Rapids Clinic
 Jori Lovdal Ph: 952-993-1517
  Email: jori.lovdal@parknicollet.com
 Matthew Boente, MDPrincipal Investigator
  Edina
 Fairview Southdale Hospital
 Betsy Wagner, RN Ph: 952-993-1555
  Email: elizabeth.wagner@parknicollet.com
 Matthew Boente, MDPrincipal Investigator
  Minneapolis
 Abbott Northwestern Hospital
 Betsy Wagner, RN Ph: 952-993-1555
  Email: elizabeth.wagner@parknicollet.com
 Matthew Boente, MDPrincipal Investigator
  St. Louis Park
 Metro Minnesota Clinical Oncology Program
 Betsy Wagner, RN Ph: 952-993-1555
  Email: elizabeth.wagner@parknicollet.com
 Matthew Boente, MDPrincipal Investigator
 Park Nicollet Frauenshuh Cancer Center
 Laura Maybon, RN Ph: 952-993-5710
  Email: laura.maybon@parknicollet.com
 Rachel Lerner, MDPrincipal Investigator
  St. Paul
 Minnesota Oncology Hematology - St. Paul Cancer Center
 Betsy Wagner, RN Ph: 952-993-1555
  Email: elizabeth.wagner@parknicollet.com
 Matthew Boente, MDPrincipal Investigator
  Woodbury
 Woodbury Clinic - CornerStone Medical Specialty Centre
 Betsy Wagner, RN Ph: 952-993-1555
  Email: elizabeth.wagner@parknicollet.com
 Matthew Boente, MDPrincipal Investigator
Mississippi
  Jackson
 St. Dominic-Jackson Memorial Hospital
 Regina Outlaw Ph: 601-987-3033
  Email: routlaw@stdom.com
 Donald Paul Seago, MDPrincipal Investigator
 University of Mississippi Cancer Clinic
 Sonya Thornhill Ph: 601-984-1963
  Email: sthornhill@umc.edu
 James T Thigpen, MDPrincipal Investigator
Missouri
  Columbia
 Ellis Fischel Cancer Center - University of Missouri
 Marta Fuemmeler Ph: 573-884-7483
  Email: fuemmelerml@health.missouri.edu
 Marc Hunter, MDPrincipal Investigator
Nevada
  Las Vegas
 Women's Cancer Care Center of Nevada
 Karen McWhirter Ph: 702-851-4672
  Email: kmcwhirter@wccenter.com
 Nicola M. Spirtos, MDPrincipal Investigator
New Hampshire
  Lebanon
 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
 Kathy Phipps Ph: 603-653-3537
  Email: kathy.j.phipps@dartmouth.edu
 Leslie DeMars, MDPrincipal Investigator
New Jersey
  Camden
 Cancer Institute of New Jersey at Cooper - Voorhees
 Maria DeFrancesco Ph: 856-325-6733
  Email: defrances-maria@cooperhealth.edu
 David Warshal, MDPrincipal Investigator
  Hackensack
 Hackensack University Medical Center Cancer Center
 Phyllis Marchand, RN Ph: 201-336-8258
  Email: pmarchand@hackensackumc.org
 Donna McNamara, MDPrincipal Investigator
New Mexico
  Albuquerque
 Southwest Gynecologic Oncology Associates
 Ruby Draper Ph: 505-263-6669
  Email: rdraper@nmcca.org
 Karen Finkelstein, MDPrincipal Investigator
 University of New Mexico Cancer Center
 Audrey Sniegowski, RN Ph: 505-925-0379
  Email: ASniegowski@salud.unm.edu
 Sarah Adams, MDPrincipal Investigator
  Las Cruces
 Memorial Medical Center
 Kim Hoffman, RN Ph: 575-556-6545
  Email: kim.hoffman@lpnt.net
 William Adler, MDPrincipal Investigator
New York
  Albany
 Women's Cancer Care Associates
 Kimberly Fredericks, BS, CCRP Ph: 518-458-1390
  Email: kfredericks@womenscancercareassociates.com
 Thomas Morrissey, MDPrincipal Investigator
  Brooklyn
 SUNY Downstate Medical Center
 Joyce McGuire Ph: 718-270-2152
  Email: joyce.mcguire@downstate.edu
 Ovadia AbulafiaPrincipal Investigator
  Buffalo
 Roswell Park Cancer Institute
 Nancy Shipkey Ph: 716-845-8631
  Email: nancy.shipkey@roswellpark.org
 Shashikant B Lele, MDPrincipal Investigator
  Lake Success
 Monter Cancer Center of the North Shore-LIJ Health System
 Rebecca Miller Ph: 516-734-8931
  Email: rmiller6@nshs.edu
 Veena John, MDPrincipal Investigator
  Manhasset
 Don Monti Comprehensive Cancer Center at North Shore University Hospital
 Rebecca Miller Ph: 516-734-8931
  Email: rmiller6@nshs.edu
 Veena John, MDPrincipal Investigator
  New Hyde Park
 Long Island Jewish Medical Center
 Rebecca Miller Ph: 516-734-8931
  Email: rmiller6@nshs.edu
 Veena John, MDPrincipal Investigator
  New York
 Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
 Reena Vattakalam Ph: 212-342-0248
  Email: rmv2110@cumc.columbia.edu
 Thomas J. HerzogPrincipal Investigator
 Memorial Sloan-Kettering Cancer Center
 Jacquelin Mohr Ph: 646-227-2239
  Email: mohrj@mskcc.org
 Kaity Chang Ph: 646-227-2252
  Email: changk@mskcc.org
 Mario Leitao, MDPrincipal Investigator
 NYU Langone Medical Center - Cancer Institute
 Benson Joseph Ph: 212-263-4408
  Email: benson.joseph@nyumc.org
 Stephanie Blank, MDPrincipal Investigator
  Syracuse
 Gynecologic Oncology of Central New York - SUNY Upstate
 Elizabeth Anderson Ph: 315-470-2620
  Email: anderse@upstate.edu
 Mary Cunningham, MDPrincipal Investigator
North Carolina
  Asheville
 Hope A Women's Cancer Center
 Laura Murphy, RN Ph: 828-670-8403
  Email: lmurphy@hopewcc.com
 Timothy Vanderkwaak, MDPrincipal Investigator
  Burlington
 Alamance Cancer Center at Alamance Regional Medical Center
 Vivian Johnson Ph: 336-538-7725
  Email: johnvivi@armc.com
 Janak Choksi, MDPrincipal Investigator
  Charlotte
 Levine Cancer Institute at Carolinas Medical Center
 Sarah Norek, RN Ph: 704-355-1520
  Email: Sarah.Norek@carolinashealthcare.org
 Robert Victor HigginsPrincipal Investigator
  Concord
 Carolinas Medical Center - Northeast
 Kelly Bumgarner Ph: 704-403-2520
  Email: Kelly.Bumgarner@carolinashealthcare.org
 Brigitte Miller, MDPrincipal Investigator
  Winston-Salem
 Wake Forest University Health Science
 Melissa Swain Ph: 336-716-9428
  Email: mswain@wfubmc.edu
 Samuel Lentz, MDPrincipal Investigator
Ohio
  Akron
 Summa Center for Cancer Care at Akron City Hospital
 Lynn Kaplan Ph: 330-375-6121
  Email: kaplanlm@summahealth.org
 Vivian Von Gruenigen, MDPrincipal Investigator
  Cincinnati
 Charles M. Barrett Cancer Center at University Hospital
 Rose Maxwell Ph: 513-584-4509
  Email: Maxwelra@ucmail.uc.edu
 Michael Blakeman
  Email: michael.blakeman@uc.edu
 Eric Eisenhauer, MDPrincipal Investigator
  Cleveland
 Case Comprehensive Cancer Center
 Susan Eaton Ph: 216-844-4710
  Email: susan.eaton@UHhospitals.org
 Steven Waggoner, MDPrincipal Investigator
 Cleveland Clinic Taussig Cancer Center
 Donna White, RN Ph: 216-444-3414
  Email: whited11@ccf.org
 Peter Rose, MDPrincipal Investigator
 Fairview Hospital Moll Pavilion Cancer Center
 Mary Smrekar Ph: 216-476-7043
  Email: masmre@ccf.org
 Peter Rose, MDPrincipal Investigator
  Columbus
 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
 Leena Hiremath Ph: 614-366-9088
  Email: leena.hiremath@osumc.edu
 David M O'Malley, MDPrincipal Investigator
  Kettering
 Women's Cancer Center at Kettering Medical Center
 Wanda Caplinger Ph: 937-395-8020
  Email: wanda.caplinger@khnetwork.org
 Heather Pulaski, MDPrincipal Investigator
  Mayfield Heights
 Hillcrest Hospital - Cleveland Clinic
 Jill Davis Ph: 440-312-4293
  Email: jdavis4@ccf.org
 Peter Rose, MDPrincipal Investigator
  Mentor
 Lake University Seidman Cancer Center
 Michele Snyder-Willis, RN Ph: 440-205-5791
  Email: michele.snyder@lhs.net
 Joel Saltzman, MDPrincipal Investigator
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Deborah Wright, RN
  Email: deborah-wright@ouhsc.edu
 Robert Mannel, MDPrincipal Investigator
  Tulsa
 Tulsa Cancer Institute
 Melissa Powell, RN Ph: 918-292-8574
  Email: melissa.powell@tciok.org
 Daron Street, MDPrincipal Investigator
Pennsylvania
  Abington
 Abington Memorial Hospital; Hanjani Institute for Gynecologic Oncology
 Susan Nolte, PhD Ph: 215-885-0220
  Email: snolte@amh.org
 Parviz Hanjani, MDPrincipal Investigator
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Heather Albertson, RN Ph: 570-214-9501
  Email: halbertson@geisinger.edu
 James R Bosscher, MDPrincipal Investigator
  Philadelphia
 Abramson Cancer Center of the University of Pennsylvania
 Cathi Ybarra, RN Ph: 215-614-0234
  Email: cathi.ybarra@uphs.upenn.edu
 Stephen Rubin, MDPrincipal Investigator
 Fox Chase Cancer Center - Philadelphia
 Kristin Padavic-Shaller, RN, MSN Ph: 215-728-5715
  Email: k_padavic@fccc.edu
 Gina Mantia-Smaldone, MDPrincipal Investigator
  Pittsburgh
 UPMC Cancer Centers
 Vicki Gilchrist, RN Ph: 412-641-6120
  Email: gilchristvb@upmc.edu
 Robert Edwards, MDPrincipal Investigator
 Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
 Mykie Bianchi Ph: 412-577-8431
  Email: mbianchi@wpahs.org
 Thomas Krivak, MDPrincipal Investigator
  West Reading
 Reading Hospital (McGlinn Family Regional Cancer Center)
 Patricia Weiser, RN Ph: 610-988-8193
  Email: weiserp@readinghospital.org
 Bernice Robinson-Bennett, MDPrincipal Investigator
Rhode Island
  Providence
 Women and Infants Hospital of Rhode Island
 Mary Dionne Ph: 401-453-7520
  Email: MDionne@WIHRI.org
 Christine Luis Ph: 401-453-7520
  Email: CLuis@Wihri.org
 Paul DiSilvestro, MDPrincipal Investigator
South Carolina
  Charleston
 Hollings Cancer Center at Medical University of South Carolina
 Anne Wulf Ph: 843-792-9321
  Email: wulf@musc.edu
 William Creasman, MDPrincipal Investigator
  Greenville
 Bon Secours St. Francis Health System
 Kristina Stoeppler-Biege, RN Ph: 864-255-1517
  Email: Kristina_stoeppler-biege@bshsi.org
 David Griffin, MDPrincipal Investigator
  Spartanburg
 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
 Heather Horton, RN Ph: 864-560-1051
  Email: hhorton@gibbscc.org
 David Griffin, MDPrincipal Investigator
South Dakota
  Sioux Falls
 Avera Cancer Institute
 Mary Fagerness, RN Ph: 605-322-7554
  Email: Mary.fagerness@avera.org
 Luis Rojas-Espaillat, MDPrincipal Investigator
Texas
  Dallas
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 Annette Paulsen Ph: 214-648-9023
  Email: annette.paulsen@utsouthwestern.edu
 David S Miller, MDPrincipal Investigator
  Galveston
 University of Texas Medical Branch
 Carroll Valdez Ph: 409-747-2056
  Email: cyvaldez@utmb.edu
 Lyuba Levine, MDPrincipal Investigator
  Houston
 M. D. Anderson Cancer Center at University of Texas
 Marcia Morris Ph: 713-745-3897
  Email: MLMorris@mdanderson.org
 Nicole Fleming, MDPrincipal Investigator
 Methodist Hospital
 Jaya Kamath Ph: 713-441-6616
  Email: jskamath@tmhs.org
 Aparna Kamat, MDPrincipal Investigator
Utah
  Salt Lake City
 Huntsman Cancer Institute at University of Utah
 Carrie Fuertes Ph: 801-587-4420
  Email: carrie.fuertes@hci.utah.edu
 Theresa Werner, MDPrincipal Investigator
Virginia
  Richmond
 Virginia Gynecology Oncology
 Deidre Belcher Ph: 804-289-4672
  Email: deidre.belcher@hcahealthcare.com
 Cecelia Boardman, MDPrincipal Investigator
  Roanoke
 Carilion Clinic Gynecological Oncology
 Sarah Henderson Ph: 540-981-0160
  Email: sehenderson@carilionclinic.org
 Janet Osborne, MDPrincipal Investigator
Washington
  Seattle
 Northwest Hospital - UW Medicine
 Monica Dherin Ph: 206-667-4696
  Email: mdherin@fhcrc.org
 Heidi J Gray, MDPrincipal Investigator
 Pacific Gynecology Specialists
 Monica Dherin Ph: 206-667-4696
  Email: mdherin@fhcrc.org
 Heidi J Gray, MDPrincipal Investigator
 Seattle Cancer Care Alliance
 Monica Dherin Ph: 206-667-4696
  Email: mdherin@fhcrc.org
 Heidi J Gray, MDPrincipal Investigator
 University Cancer Center at University of Washington Medical Center
 Monica Dherin Ph: 206-667-4696
  Email: mdherin@fhcrc.org
 Heidi J Gray, MDPrincipal Investigator
 Women's Cancer Care of Seattle
 Monica Dherin Ph: 206-667-4696
  Email: mdherin@fhcrc.org
 Heidi J Gray, MDPrincipal Investigator
Wisconsin
  Green Bay
 Green Bay Oncology at St. Mary's Hospital
 Christy Gilchrist Ph: 920-433-8272
  Email: christy.gilchrist@hshs.org
 Jonathan E. Tammela, MDPrincipal Investigator
 Green Bay Oncology at St. Vincent's Hospital
 Christy Gilchrist Ph: 920-433-8272
  Email: christy.gilchrist@hshs.org
 Jonathan E. Tammela, MDPrincipal Investigator
 St Vincent Hospital
 Christy Gilchrist Ph: 920-433-8272
  Email: christy.gilchrist@hshs.org
 Jonathan E. Tammela, MDPrincipal Investigator
  Madison
 University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
 Sarah Stewart Ph: 608-263-0796
  Email: slstewart@wisc.edu
 Gigi Miller Ph: 608-263-7282
  Email: gigi.miller@obgyn.wisc.edu
 David Kushner, MDPrincipal Investigator
  Manitowoc
 Holy Family Memorial Medical Center Cancer Care Center
 Christy Gilchrist Ph: 920-433-8272
  Email: christy.gilchrist@hshs.org
 Jonathan E. Tammela, MDPrincipal Investigator
  Marinette
 Bay Area Cancer Care Center at Bay Area Medical Center
 Christy Gilchrist Ph: 920-433-8272
  Email: christy.gilchrist@hshs.org
 Jonathan E. Tammela, MDPrincipal Investigator
  Marshfield
 Marshfield Clinic - Marshfield Center
 Paula Nesbitt, RN Ph: 715-387-5743
  Email: nesbitt.paula@mcrf.mfldclin.edu
 Anthony C. Evans, Jr., MD, PhDPrincipal Investigator
  Milwaukee
 Aurora St. Luke's Medical Center Gynecologic Oncology
 Valerie Werner Ph: 414-977-5281
  Email: valerie.werner@aurora.org
 Scott Kamelle, MDPrincipal Investigator
 Medical College of Wisconsin Cancer Center
 Qiana Christian Ph: 414-805-4763
  Email: qchristian@mcw.edu
 William Bradley, MDPrincipal Investigator
  Wausau
 University of Wisconcin Cancer Center at Aspirus Wausau Hospital
 Beth Knetter Ph: 715-847-2353
  Email: Beth.Knetter@aspirus.org
 Christopher Peterson, MDPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01666444
ClinicalTrials.gov processed this data on March 23, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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