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A Study of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Ovary, Peritoneal, or Fallopian Tube Carcinoma

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive18 and overPharmaceutical / IndustryAVF4095g
NCT00434642

Trial Description

Summary

This is a placebo-controlled, randomized, multicenter Phase III study evaluating the safety and efficacy of bevacizumab, administered in combination with carboplatin with gemcitabine in women with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.

Eligibility Criteria

Inclusion Criteria:

  • Signed Informed Consent Form
  • Age ≥ 18 years
  • Documented ovarian, primary peritoneal, or fallopian tube carcinoma that has recurred
  • No prior chemotherapy in the recurrent setting
  • Measurable disease
  • Recovered from prior radiation therapy or surgery

Exclusion Criteria:

  • Prior chemotherapy treatment for recurrent ovarian, primary peritoneal, or fallopian tube carcinoma.
  • History of abdominal fistula, GIP, or intra-abdominal abscess
  • Patients with clinical symptoms or signs of GI obstruction or who require parenteral hydration, parenteral nutrition, or tube feeding
  • Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure
  • Current, recent, or planned participation in an experimental drug study
  • History of systemic bevacizumab (Avastin(R)) or other VEGF or VEGF receptor-targeted agent use
  • Inadequately controlled hypertension
  • Prior history of hypertensive crisis or hypertensive encephalopathy
  • New York Heart Association Class II or greater CHF
  • History of myocardial infarction or unstable angina
  • History of stroke or transient ischemic attack (TIA)
  • Known CNS disease except for treated brain metastasis
  • Significant vascular disease or recent peripheral arterial thrombosis
  • History of hemoptysis
  • Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)

Trial Contact Information

Trial Lead Organizations/Sponsors

Genentech Incorporated

Hua Mu, M.D., Ph.D.Study Director

Genentech Trial Information Support LinePh: 888-662-6728

Trial Sites

U.S.A.
Alabama
  Birmingham
 UAB Comprehensive Cancer Center
 Jolane Gable Ph: 205-930-8654
  Email: jgable@uabmc.edu
  Huntsville
 Clearview Cancer Institute
 Chastity Davis Ph: 256-705-4249
  Email: chastityd@ccihsv.com
Arizona
  Sedona
 North AZ Hem/Onc Assoc
 Karen Freriks Ph: 928-204-4198
  Tucson
 Arizona Oncology HOPE
 Julie Klinker Ph: 520-877-9052
  Email: julie.klinker@usoncology.com
California
  Berkeley
 Alta Bates Summit Comprehensive Cancer Center
 Laurie Logan Ph: 510-204-3428
  Email: llogan@aptiumoncology.com
  Gilroy
 Ronald H. Yanagihara
 Michiko Beck Ph: 408-847-6194
  Email: michikobeck@aol.com
  Greenbrae
 California Cancer Care, Incorporated - Greenbrae
 Jaime Chang Ph: 415-925-5040
  Email: jchang@cal-cancer-care.com
  La Jolla
 Rebecca and John Moores UCSD Cancer Center
 Ashley Tydon Ph: 858-822-5378
  Email: atydon@ucsd.edu
  Los Angeles
 Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
 Paula Anastasia Ph: 310-412-3348
  Email: anastasiap@cshs.org
 USC/Norris Comprehensive Cancer Center and Hospital
 Grace Facio Ph: 323-226-7027
  Email: gfacio@ccnt.hsc.usc.edu
  Newport Beach
 Gynecologic Oncology Assoc
 Michelle Erwin Ph: 949-642-5165
  Email: michelle.erwin@gynoncology.com
  Pleasanton
 Valley Medical Oncology Consultants - Pleasanton
 Christine Raymond Ph: 925-734-8130
  San Francisco
 UCSF Helen Diller Family Comprehensive Cancer Center
 Lillian Hu Ph: 415-885-7206
  Email: HuL1@obgyn.ucsf.edu
  Stanford
 Stanford Cancer Center
 Tine Bjornlund Ph: 650-724-7826
  Email: tbjorn@stanford.edu
Colorado
  Aurora
 University of Colorado Cancer Center at UC Health Sciences Center
 Sidney McIntosh Ph: 720-848-0681
  Email: sidney.mcintosh@uchsc.edu
  Englewood
 Rocky Mountain Gynecologic Onc
 Nancy Meija Ph: 303-781-9090
  Email: nancy.mejia@rmgo.net
  Fort Collins
 Front Range Cancer Specialists
 Judy Shelby Ph: 970-212-7600
  Email: jshelby@frontrangecancer.com
Connecticut
  New Britian
 The Hospital of Central CT
 Jason Quarles Ph: 860-224-5900 ext. 6717
  Email: jquarles@thocc.org
  New Haven
 Yale Cancer Center
 Lisa Baker Ph: 203-785-6398
  Email: lisa.baker@yale.edu
  Norwalk
 Norwalk Hospital
 Linda Versea Ph: 203-855-3517
  Email: linda.versea@norwalkhealth.org
  Stamford
 Hematology Oncology, PC at Bennett Cancer Center
 Sue Murdock Ph: 203-964-9578
  Email: hoa_researchsm@yahoo.com
District of Columbia
  Washington
 Washington Cancer Institute at Washington Hospital Center
 Velega Roberts Ph: 202-877-8517
  Email: Velega.E.Roberts@medstar.net
Florida
  Boynton Beach
 Hematology and Medical Oncology of Southern Palm Beach County, Incorporated
 Mariana Ailincai Ph: 561-209-2062
  Email: pbiho@aim.com
  Gainsville
 Gainesville Hematology Oncology Associates
 Kelly Beauchamp Ph: 352-264-2540
  Email: ghoa_crc@hotmail.com
  Lakeland
 Center for Cancer Care and Research at Watson Clinic, LLP
 June Huchingson Ph: 863-603-4723
  Email: jhuchingson@watsonclinic.com
 Lakeland Regional Cancer Ctr
 Robin Stewart Ph: 863-904-1877
  Email: robin.stewart@lrmc.com
  Orlando
 Florida Hospital Cancer Institute
 Teal Stocker Ph: 407-303-2090
  Email: teal.stocker@flhosp.org
  Saint Petersburg
 Bayfront Cancer Care Center at Bayfront Medical Center
 Tabetha Swartz Ph: 727-821-9688
  Email: tabetha.swartz@bayfront.org
Georgia
  Atlanta
 Piedmont Hospital
 Michelle Humphreys Ph: 404-605-1919
  Email: michelle.humphreys@piedmont.org
  Augusta
 Medical College of Georgia Cancer Center
 Sara Mobley Ph: 706-721-4726
  Email: smobley@mcg.edu
  Rome
 Harbin Clinic Cancer Center - Medical Oncology
 Terri Brannon Ph: 706-234-1400
  Email: tbrannon@harbinclinic.com
Hawaii
  Honolulu
 Kaiser Permanente Medical Ctr
 Marc Takemoto, PharmD Ph: 808-432-8589
  Email: marc.h.takemoto@kp.org
 Women's Cancer Center
 Felix Militante
  Email: felix.militante@wilcoxhealth.org
Idaho
  Boise
 Mountain States Tumor Institute at St. Luke's Regional Medical Center
 Susan Mahoney Ph: 208-463-6076
  Email: mahoneys@slrmc.org
Illinois
  Evanston
 Palliative CareCenter and Hospice of the North Shore
 Sharon Goldman Ph: 847-570-1173
  Email: sgoldman@enh.org
  Hinsdale
 Sudarshan K. Sharma, MD, Ltd.
 Peg Gregus Ph: 630-856-6757
  Email: drsharma@ameritech.net
  Maywood
 Cardinal Bernardin Cancer Center at Loyola University Medical Center
 Kathy Czaplicki Ph: 708-327-3222
  Email: kczapli@lumc.edu
  Niles
 Oncology Specialists SC
 Elena Bogdanova Ph: 847-410-0659
  Email: ebogdanova@oncmed.net
  Urbana
 Carle Cancer Center at Carle Foundation Hospital
 Brian Moses Ph: 217-326-1881 217-326-1881
  Email: brian.moses@carle.com
Indiana
  Indianapolis
 St. Francis Medical Group
 Jayme Harvey Ph: 317-921-2050
  Email: harveyj@iupui.edu
Kansas
  Kansas City
 Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
 Marilyn Labinski Ph: 913-588-4254
  Email: mlabinski@kumc.edu
Kentucky
  Lexington
 Lucille P. Markey Cancer Center at University of Kentucky
 Shar Ellixson Ph: 859-323-3975
  Louisville
 Louisville Oncology at Norton Cancer Institute - Louisville
 Randi Eden Ph: 502-629-5954
Louisiana
  New Orleans
 Ochsner Cancer Institute at Ochsner Clinic Foundation
 Melanie Zazulak Ph: 504-842-4478
  Email: mzazulak@oschner.org
Maryland
  Baltimore
 Greater Baltimore Medical Center Cancer Center
 Lauren Titus Ph: 443-849-3285
  Email: ltitus@gbmc.org
 Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
 Jean Flack Ph: 443-777-7364
  Email: jean.flack@medstar.net
  Silver Spring
 Capitol Hematology and Oncology
 Kristin Sorenstein Ph: 301-933-3216 Ext.214
Massachusetts
  Boston
 Boston University Cancer Research Center
 Linda Frattura Ph: 617-638-4178
  Email: linda.frattura@bmc.org
  Burlington
 Lahey Clinic Medical Center - Burlington
 Jacqueline Draper Ph: 781-744-7487
  Email: jacqueline.t.draper@lahey.org
Michigan
  Detroit
 Barbara Ann Karmanos Cancer Institute
 Susan Newell Ph: 313-576-8419
  Email: snewell@med.wayne.edu
  Grand Rapids
 Gynecologic Oncology of West Michigan
 Amber Door Ph: 616-957-3398
  Email: amber.door@spectrum-health.org
Minnesota
  Minneapolis
 Masonic Cancer Center at University of Minnesota
 Jennifer Engen Ph: 612-626-1421
  Email: engen081@umn.edu
  Saint Louis Park
 Park Nicollet Cancer Center
 Elaine Bell Ph: 952-993-6705
  Email: Elaine.Bell@parknicollet.com
  St Paul
 MN Oncology, St Paul CA Care
 Anne Dombrock Ph: 651-241-8326
  Email: anne.dombrock@allina.com
Missouri
  Kansas City
 St. Luke's Hospital of KS City
 Jill Trunecek Ph: 816-932-2562
Nebraska
  Lincoln
 Southeast Nebraska Cancer Center
 Amy Akins, RN Ph: 402-327-7363
  Email: amya@senhoc.com
Nevada
  Las Vegas
 Women's Cancer Center
 Danielle Turner Ph: 702-851-4672
  Email: dturner@wccenter.com
New Jersey
  Hackensack
 Hackensack University Medical Center Cancer Center
 Loryn Albano Ph: 201-996-4037
  Email: lalbano@humed.com
  Livingston
 St. Barnabas Medical Center Cancer Center
 Rosa Gonzalez Ph: 973-322-5170
  Email: rogonzalez@sbhcs.com
  Morristown
 Carol G. Simon Cancer Center at Morristown Memorial Hospital
 Christine Koranyi Ph: 973-971-5235
  Email: christine.koranyi@atlantichealth.org
  Neptune
 Jersey Shore Cancer Center at Jersey Shore University Medical Center
 LaShawn Jenkins Ph: 732-776-2416
  Email: ljenkins@meridianhealth.com
  Paramus
 Luckow Pavillion, Valley Hosp
 Susan Mock Ph: 201-634-5793
  Email: smock@valleyhealth.com
  Summit
 Overlook Hospital
 Eloise Heacock Ph: 908-522-2043
  Email: eloise.heacock@atlantichealth.org
New York
  Brightwaters
 Schwartz Oncology
 Jacklyn Frizalone Ph: 631-894-1033
  Email: jf@schwwartzoncology.com
  Buffalo
 Roswell Park Cancer Institute
 Bridget Thomas Ph: 716-845-1178
  Email: bridget.thomas@roswellpark.org
  New York
 Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
 Ryann Webster Ph: 212-305-8243
  Email: rw2357@columbia.edu
 Memorial Sloan-Kettering Cancer Center
 Carol Aghajanian Ph: 212-639-2252
  Email: aghajanc@mskcc.org
 NYU Cancer Institute at New York University Medical Center
 Christina Lam Ph: 212-263-4427
  Email: christina.lam@nyumc.org
North Carolina
  Asheville
 Hope A Women's Cancer Center
 Jennifer Ackerman Ph: 828-418-1354
  Email: jackerman@hopeawcc.com
  Chapel Hill
 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
 Elizabeth Hill Ph: 919-843-1656
  Email: elizabeth_hill@med.unc.edu
  Charlotte
 McKay Urology
 Sarah Norek Ph: 704-355-1520
  Email: sarah.norek@carolinashealthcare.org
 Presbyterian Hospital
 Michealla Muhammad Ph: 704-947-6599 Ext.106
  Email: michealla.muhammad@carolinabiooncology.org
  Greenville
 Brody School of Medicine at East Carolina University
 Mindy Friday Ph: 252-744-1015
  Email: fridaym@edu.edu
  Winston-Salem
 Piedmont Hematology-Oncology Associates
 Suzette Brown Ph: 336-277-8890
  Email: sbrown@phoa.org
Ohio
  Canton
 Aultman Cancer Center at Aultman Hospital
 Carolyn Lovette Ph: 330-363-4857
  Email: clovette@aultman.com
 Gabrail Cancer Center - Canton Office
 Carrie Smith Ph: 330-492-3345 Ext.208
  Email: csmith@gabrailcancercenter.com
  Cincinnati
 Oncology Hematology Care, Incorporated - Blue Ash
 Ann Bradley Ph: 513-891-4800
  Email: abradley@ohcmail.com
  Cleveland
 Case Comprehensive Cancer Center
 Ramon Adams Ph: 216-844-8724
  Email: ramon.adams@uhhospitals.org
 Cleveland Clinic Taussig Cancer Center
 Denise Howard Ph: 216-445-9766
  Email: howardd@ccf.org
 MetroHealth Cancer Care Center at MetroHealth Medical Center
 Donna White Ph: 216-778-1391
  Email: dwhite@metrohealth.org
  Columbus
 Riverside Methodist Hospital Cancer Care
 Jennie Key
  Email: gognurse@hotmail.com
 The Mark H. Zangmeister Center
 Nancy Merriman Ph: 614-383-6236
  Email: NMerriman@zangcenter.com
  Dayton
 David L. Rike Cancer Center at Miami Valley Hospital
 Wanda Caplinger Ph: 937-208-6087
  Email: wpcaplinger@MVH.org
Oregon
  Eugene
 Willamette Vly CA Inst Rsch
 Lisa Cone Ph: 541-868-2543
  Email: lisa.cone@usoncology.com
Pennsylvania
  Abington
 Rosenfeld Cancer Center at Abington Memorial Hospital
 Susan Nolte Ph: 215-885-0220
  Email: snolte@amh.org
  Pittsburgh
 UPMC Cancer Center at Magee-Womens Hospital
 Vickie Gilchrist Ph: 412-641-4365
  Email: gilchristvb@upmc.edu
Rhode Island
  Providence
 Women and Infants Hospital of Rhode Island
 Roxanne Wood Ph: 401-274-1122 Ext.2882
  Email: rwood@WIHRI.org
South Carolina
  Columbia
 South Carolina Oncology Associates, PA
 Debby Greene Ph: 803-461-3093
  Email: dgreene@sconcology.net
  Greenville
 Cancer Ctrs of the Carolinas
 Melanie Mayes Ph: 864-327-3564
  Email: melanie.mayes@usoncology.com
South Dakota
  Sioux Falls
 Sanford School of Medicine
 Lora Black Ph: 605-328-1388
  Email: blackl@sanfordhealth.org
Tennessee
  Chattanooga
 Chamberlain, Donald
 Colleen Ford Canion Ph: 423-698-2050
  Email: colleeen@chatgynonc.com
 TN GYN Oncology Group, LLC
 Alice Donaldson Ph: 423-266-3636
Texas
  Austin
 Texas Oncology, PA at Texas Oncology Cancer Center - Central
 Shanna Bond Ph: 512-427-9492
  Email: Shanna.Bond@usoncology.com
  Bedford
 Texas Oncology, PA at Harris Center HEB
 Cynthia Schoenfeldt Ph: 817-359-9033
  Email: cynthia.schoenfeldt@usoncology.com
  Corpus Christi
 South Texas Institute of Cancer - Northwest
 Yvonne Hayes Ph: 361-737-0626
  Email: yhayes@stioc.com
  Dallas
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 Shelley Sheridan Ph: 214-648-7094
  Email: Shelly.Sheridan@UTSouthwestern.edu
 Texas Oncology, PA at Charles A. Sammons Cancer Center
 Marnie Fisher Ph: 214-370-1038
  Email: Marnie.Fisher@USONCOLOGY.COM
 Texas Oncology, PA at Presbyterian Hospital Dallas
 Kaylene Smith Ph: 214-346-3508
  Email: Kaylene.Smith@usoncology.com
  El Paso
 Texas Oncology, PA at El Paso Cancer Treatment Center - East
 Noemi Salcido Ph: 915-747-4878
  Email: noemi.salcido@usoncology.com
  Fort Worth
 Texas Oncology, PA - Fort Worth
 Annette Alexander
  Tyler
 Tyler Cancer Center
 Linda Dunklin Ph: 903-579-9867
  Email: linda.dunklin@USOncology.com
  Waco
 Texas Oncology, PA Cancer Care and Research Center
 Theresa Schroeder Ph: 254-399-0741
  Email: theresa.schroeder@usoncology.com
Virginia
  Annandale
 Northern Virginia Pelvic Surgery Associates
 Sheila Whitt Ph: 703-698-7100 Ext.318
  Email: swhitt@nvpsa.net
  Norfolk
 Virginia Oncology Associates - Lake Wright
 Helen Clark Ph: 757-873-9810
  Roanoke
 Carilion Gynecologic Oncology Associates
 Stacey Benedetto Ph: 540-345-8574
  Salem
 Gyn-Oncology of Southwest Virgina
 Charlene Viers Ph: 540-774-8660 ext 215
  Email: charlene.viers@usoncology.com
Washington
  Kirkland
 Cascade Cancer Center at Evergreen Hospital Medical Center
 Brenda Havens Ph: 425-285-3928
  Email: bhavens@cascadecancercenter.com
  Seattle
 Puget Sound Cancer Centers - Seattle
 Timothy Gallagher Ph: 206-365-8252
  Email: timothy.gallagher@uso.com
 Univ of WA School of Medicine
 Barbara Buening Ph: 206-667-5153
  Email: bbuening@fhcrc.org
  Spokane
 Cancer Care Northwest - Spokane South
 Lori Mayhle Ph: 509-228-1226
  Tacoma
 Northwest Medical Specialties, PLLC - Tacoma
 Jeni Spokely Ph: 253-396-5334
  Email: jspokely@nwmsonline.com
  Vancouver
 Northwest Cancer Specialists at Vancouver Cancer Center
 Lisa Justice Ph: 360-449-6521
  Email: lisa.justice@usoncology.com
Wisconsin
  Madison
 University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
 Sarah Stewart Ph: 608-263-0796
  Email: slstewart@wisc.edu

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00434642
Information obtained from ClinicalTrials.gov on October 25, 2009

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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