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Clinical Trials (PDQ®)

Carboplatin and Paclitaxel With or Without Cisplatin and Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IVA Endometrial Cancer

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed18 and olderNCI, OtherGOG-0258
NCI-2011-01951, CDR0000649079, U10CA027469, NCT00942357

Trial Description

Summary

This randomized phase III trial studies carboplatin and paclitaxel to see how well they work with or without cisplatin and radiation therapy in treating patients with stage I, stage II, stage III, or stage IVA endometrial cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving chemotherapy and radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether carboplatin and paclitaxel are more effective with or without cisplatin and radiation therapy in treating patients with endometrial cancer.

Further Study Information

PRIMARY OBJECTIVES:

I. To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of recurrence or death (i.e., increases recurrence-free survival) when compared to chemotherapy consisting of carboplatin and paclitaxel for 6 cycles (control arm) in patients with Stages III-IVA endometrial carcinoma (< 2 cm residual disease) or patients with Federation of Gynecology and Obstetrics (FIGO) 2009 Stage I or II serous (UPSC) or clear cell endometrial carcinoma and positive cytology.

SECONDARY OBJECTIVES:

I. To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of death (i.e., increases survival) when compared to chemotherapy consisting of carboplatin and paclitaxel for 6 cycles (control arm) in patients with Stages III-IVA endometrial carcinoma (< 2 cm residual disease) or patients with FIGO 2009 Stage I or II serous (UPSC) or clear cell endometrial carcinoma and positive cytology.

II. To compare the regimens with respect to acute and late adverse effects of therapy.

III. To determine the impact of patient-reported Quality of Life during and following treatment for up to 1 year with the two treatment regimens.

TERTIARY OBJECTIVES:

I. To bank formalin-fixed, paraffin-embedded (FFPE) tumor tissue and whole blood specimens for future research.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive cisplatin intravenously (IV) on days 1 and 29. Patients also undergo external-beam radiotherapy once daily (QD), 5 days a week, for 5-6 weeks. Some patients may then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients complete quality-of-life questionnaires at baseline and periodically during study using the Functional Assessment of Cancer Therapy (FACT)-general (G) Physical and Functional Well-Being, FACT-Endometrial, FACT/Gynecologic Oncology Group (GOG) Neuropathy, and FACT-C (items C3 and C5).

After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Eligibility Criteria

Inclusion Criteria:

  • All patients with surgical stage III or IVA endometrial carcinoma per FIGO 2009 staging criteria including clear cell and serous papillary and undifferentiated carcinoma
  • Surgical stage III disease includes those patients with positive adnexa, parametrial involvement, tumor invading the serosa, positive pelvic and/or para-aortic nodes, or vaginal involvement
  • Surgical stage IVA patients with bladder or bowel mucosal involvement, but no spread outside the pelvis
  • Patients with FIGO 2009 surgical Stage I or II endometrial clear cell or serous carcinoma and with positive peritoneal cytology
  • Surgery must have included a hysterectomy and bilateral salpingo-oophorectomy; pelvic lymph node sampling and para-aortic lymph node sampling are optional
  • Patients with a GOG Performance Status of 0, 1, or 2
  • White blood cell (WBC) >= 3,000/mcl
  • Absolute neutrophil count (ANC) >= 1,500/mcl
  • Platelet count >= 100,000/mcl
  • Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvate transaminase (SGPT) =< 2.5 x upper limit of normal (ULN)
  • Alkaline phosphatase =< 2.5 times ULN
  • Bilirubin =< 1.5 times ULN
  • Creatinine =< institutional ULN
  • Patients who have met the pre-entry requirements, testing values/results must meet eligibility criteria
  • Patients who have signed an approved informed consent and authorization permitting release of personal health information
  • Entry into the study is limited to no more than 8 weeks from the date of surgery

Exclusion Criteria:

  • Patients with carcinosarcoma
  • Patients with recurrent endometrial cancer
  • Patients with residual tumor after surgery (any single site) exceeding 2 cm in maximum dimension
  • Patients who have had pelvic or abdominal radiation therapy
  • Patients with positive pelvic washings as the only extra-uterine disease are NOT eligible if the histology is other than clear cell or papillary serous carcinoma
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of active malignancy within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
  • Patients with a history of serious co-morbid illness or uncontrolled illnesses that would preclude protocol therapy
  • Patients with an estimated survival of less than three months
  • Patients with FIGO 2009 Stage IVB endometrial cancer
  • Patients with parenchymal liver metastases
  • Patients who have received prior chemotherapy for endometrial cancer
  • Patients with a history of myocardial infarction, unstable angina, or uncontrolled arrhythmia within 3 months from enrollment

Trial Contact Information

Trial Lead Organizations/Sponsors

Gynecologic Oncology Group

National Cancer Institute

Daniela MateiPrincipal Investigator

Trial Sites

U.S.A.
Alaska
  Anchorage
 Providence Cancer Center
 Alison K Conlin Ph: 503-215-6412
California
  Antioch
 Kaiser Permanente - Deer Valley
 Louis Fehrenbacher Ph: 626-564-3455
  Auburn
 Auburn Radiation Oncology
 Christopher Jones Ph: 916-454-6500
  Email: cancerinfo@sutterhealth.org
  Cameron Park
 Radiation Oncology Centers - Cameron Park
 Christopher Jones Ph: 916-454-6500
  Email: cancerinfo@sutterhealth.org
  Carmichael
 Mercy Cancer Center at Mercy San Juan Medical Center
 Christopher Jones Ph: 916-454-6500
  Email: cancerinfo@sutterhealth.org
  Fremont
 Kaiser Permanente - Fremont
 Louis Fehrenbacher Ph: 626-564-3455
  Fresno
 Kaiser Permanente Fresno Medical Center
 Louis Fehrenbacher Ph: 626-564-3455
  Los Angeles
 Kaiser Permanente Medical Center - Los Angeles
 Scott E. Lentz Ph: 626-564-3455
 Scott E. Lentz Ph: 626-564-3455
  Modesto
 Kaiser Permanente-Modesto
 Louis Fehrenbacher Ph: 626-564-3455
 Memorial Medical Center
 Jorge A Garcia-Young Ph: 209-572-7116
  Roseville
 Radiation Oncology Center - Roseville
 Christopher Jones Ph: 916-454-6500
  Email: cancerinfo@sutterhealth.org
  Sacramento
 Sutter Cancer Center
 Stacy D D'Andre Ph: 916-454-6500
  Email: cancerinfo@sutterhealth.org
  Santa Clara
 Kaiser Permanente Medical Center - Santa Clara Homestead Campus
 Louis Fehrenbacher Ph: 626-564-3455
  Stanford
 Stanford Cancer Center
 Jonathan S. Berek Ph: 650-498-7061
  Email: clinicaltrials@med.stanford.edu
  Vacaville
 Kaiser Permanente Medical Center - Vacaville
 Louis Fehrenbacher Ph: 626-564-3455
 Solano Radiation Oncology Center
 Christopher Jones Ph: 916-454-6500
  Email: cancerinfo@sutterhealth.org
  Vallejo
 Kaiser Permanente Medical Center - Vallejo
 Louis Fehrenbacher Ph: 626-564-3455
Connecticut
  Bridgeport
 Bridgeport Hospital
 Sheida Mani Ph: 203-384-4869
Delaware
  Newark
 Christiana Gynecologic Oncology, LLC
 Mark E Borowsky Ph: 302-733-6227
 Delaware Clinical and Laboratory Physicians
 Mark E Borowsky Ph: 302-733-6227
 Helen F. Graham Cancer Center at Christiana Hospital
 Mark E Borowsky Ph: 302-733-6227
 Medical Oncology Hematology Consultants, PA at Helen F. Graham Cancer Center
 Mark E Borowsky Ph: 302-733-6227
 Regional Hematology/Oncology, PA - Newark
 Mark E Borowsky Ph: 302-733-6227
  Rehoboth Beach
 Beebe Health Campus
 Mark E Borowsky Ph: 302-733-6227
  Seaford
 Nanticoke Memorial Hospital
 Mark E Borowsky Ph: 302-733-6227
  Wilmington
 Christiana Care Health System-Wilmington Hospital
 Mark E Borowsky Ph: 302-733-6227
Florida
  Altamonte Springs
 Florida Hospital - Altamonte
 James E Kendrick Ph: 407-303-5623
  Kissimmee
 Florida Hospital Kissimmee
 James E Kendrick Ph: 407-303-5623
  Lakeland
 Lakeland Regional Cancer Center at Lakeland Regional Medical Center
 Richard A. Boothby Ph: 863-904-1900
  Miami
 Jackson Memorial Hospital
 Aaron H Wolfson Ph: 866-574-5124
  Email: Sylvester@emergingmed.com
  Orlando
 Florida Hospital East Orlando
 James E Kendrick Ph: 407-303-5623
  Sarasota
 Sarasota Memorial Hospital
 James V. Fiorica Ph: 941-917-2225
  Winter Park
 Florida Hospital Cancer Institute at Winter Park
 James E Kendrick Ph: 407-303-5623
Georgia
  Atlanta
 Piedmont Hospital
 Adam W Nowlan Ph: 404-425-7943
  Email: ORS@piedmont.org
 Winship Cancer Institute of Emory University
 Namita Khanna Ph: 404-778-1868
  Savannah
 Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
 William Edward Richards Ph: 800-622-6877
  Email: uchealthnews@uc.edu
Hawaii
  Honolulu
 Kaiser Permanente - Moanalua Medical Center and Clinic
 Louis Fehrenbacher Ph: 626-564-3455
 Kapiolani Medical Center for Women and Children
 Michael E. Carney Ph: 808-983-6090
 MBCCOP - Hawaii
 Michael E. Carney Ph: 808-983-6090
 OnCare Hawaii, Incorporated - Kuakini
 Michael E. Carney Ph: 808-983-6090
 OnCare Hawaii, Incorporated - Lusitana
 Michael E. Carney Ph: 808-983-6090
  Lihue
 Kauai Medical Clinic
 Michael E. Carney Ph: 808-983-6090
Idaho
  Lewiston
 St. Joseph Regional Medical Center
 John A Keech Ph: 253-887-9333
Illinois
  Aurora
 Rush-Copley Cancer Care Center
 Ronald A Sapiente Ph: 800-446-5532
  Danville
 Carle on Vermilion
 Ronald A Sapiente Ph: 800-446-5532
  Effingham
 Carle Physician Group-Effingham
 Ronald A Sapiente Ph: 800-446-5532
  Galesburg
 Medical and Surgical Specialists, LLC
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Mattoon
 Carle Physician Group-Mattoon/Charleston
 Ronald A Sapiente Ph: 800-446-5532
  Mount Vernon
 Good Samaritan Regional Health Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
  Peru
 Illinois CancerCare - Princeton
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Princeton
 Illinois CancerCare - Princeton
 Nguyet A Le-Lindqwister Ph: 800-793-2262
  Urbana
 Carle Cancer Center at Carle Foundation Hospital
 Ronald A Sapiente Ph: 800-446-5532
 Ronald A Sapiente Ph: 800-446-5532
  Yorkville
 Rush-Copley Healthcare Center
 Ronald A Sapiente Ph: 800-446-5532
Indiana
  Beech Grove
 St. Francis Hospital and Health Centers - Beech Grove Campus
 David H Moore Ph: 317-851-2555
  Dyer
 Franciscan Saint Margaret Health - Dyer Campus
 Robert D Prock Ph: 708-891-9305
  Fort Wayne
 Parkview Regional Cancer Center at Parkview Health
 Brian K Chang Ph: 260-373-8888
  Email: parkviewresearch@parkview.com
 Radiation Oncology Associates Southwest
 Brian K Chang Ph: 260-373-8888
  Email: parkviewresearch@parkview.com
  Hammond
 Oncology Center at Saint Margaret Mercy Healthcare Center
 Robert D Prock Ph: 708-891-9305
  Indianapolis
 St. Francis Hospital Cancer Care Services
 David H Moore Ph: 317-851-2555
  Michigan City
 Saint Anthony Memorial Health Centers
 Ronald A Sapiente Ph: 800-446-5532
 Woodland Cancer Care Center
 Ronald A Sapiente Ph: 800-446-5532
Iowa
  Clive
 Mercy Cancer Center - West Lakes
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
  West Des Moines
 Methodist West Hospital
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
 Robert J Behrens Ph: 888-244-6061
  Email: sherrijr@iora.org
Kentucky
  Crestview Hills
 Oncology Hematology Care, Incorporated - Crestview Hills
 Howard M. Gross Ph: 765-983-3000
Massachusetts
  Boston
 Tufts Medical Center Cancer Center
 Michael G Kelly Ph: 336-713-6771
  Email: ContactUsCancerCenter@TuftsMedicalCenter.org
Michigan
  Niles
 Lakeland Hospital - Niles
 Michael Rodriguez Ph: 574-237-1328
  Novi
 Henry Ford Medical Center-Columbus
 Thomas E Buekers Ph: 313-916-1784
  Royal Oak
 William Beaumont Hospital - Royal Oak Campus
 Donald S. Brabbins Ph: 248-551-7695
  Trenton
 Down River Center for Oncology
 Thomas E Buekers Ph: 313-916-1784
  Troy
 William Beaumont Hospital - Troy Campus
 Donald S. Brabbins Ph: 248-551-7695
  West Bloomfield
 Henry Ford Medical Center - West Bloomfield
 Thomas E Buekers Ph: 313-916-1784
Missouri
  Joplin
 Freeman Cancer Institute at Freeman Health System
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
 St. John's Regional Medical Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
  Rolla
 Mercy Clinic Cancer and Hematology - Rolla
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
 Phelps County Regional Medical Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
  Saint Louis
 David C. Pratt Cancer Center at St. John's Mercy
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
Nevada
  Henderson
 Comprehensive Cancer Centers of Nevada - Henderson
 John Allan Ellerton Ph: 702-384-0013
  Las Vegas
 Cancer and Blood Specialists-Tenaya
 John Allan Ellerton Ph: 702-384-0013
 Cancer Therapy and Integrative Medicine
 John Allan Ellerton Ph: 702-384-0013
 Children's Specialty Center of Nevada
 John Allan Ellerton Ph: 702-384-0013
New Jersey
  Hackensack
 CCOP - Northern New Jersey
 Donna T McNamara Ph: 201-996-2879
 Hackensack University Medical Center Cancer Center
 Donna T McNamara Ph: 201-996-2879
  Sparta
 Frederick R. and Betty M. Smith Cancer Treatment Center
 Norman G. Rosenblum Ph: 215-955-6084
New York
  New York
 New York Weill Cornell Cancer Center at Cornell University
 Divya Gupta Ph: 212-746-1848
  Rochester
 Daisy Marquis Jones Radiation Oncology Center at Highland Hospital of Rochester
 Yuhchyau Chen Ph: 585-275-5830
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Yuhchyau Chen Ph: 585-275-5830
North Carolina
  Concord
 Batte Cancer Center at Northeast Medical Center
 Brigitte E. Miller Ph: 704-403-1520
  Pinehurst
 FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
 John W. Byron Ph: 910-715-2200
Ohio
  Cincinnati
 Good Samaritan Hospital Cancer Treatment Center
 James C Pavelka Ph: 513-862-2230
 Oncology Hematology Care Inc - Western Hills
 Howard M. Gross Ph: 765-983-3000
 Oncology Hematology Care, Incorporated - Anderson
 Howard M. Gross Ph: 765-983-3000
 Oncology Hematology Care, Incorporated - Blue Ash
 Howard M. Gross Ph: 765-983-3000
 Oncology Hematology Care, Incorporated - Kenwood
 Howard M. Gross Ph: 765-983-3000
 Oncology Hematology Care, Incorporated - Mt. Auburn/Taft Road
 Howard M. Gross Ph: 765-983-3000
  Dayton
 CCOP - Dayton
 Howard M. Gross Ph: 765-983-3000
 Grandview Hospital
 Thomas J. Reid Ph: 937-298-3399
  Email: uchealthnews@uc.edu
  Fairfield
 Oncology Hematology Care, Incorporated - Fairfield Healthplex
 Howard M. Gross Ph: 765-983-3000
  Greenville
 Wayne Hospital
 Howard M. Gross Ph: 765-983-3000
Pennsylvania
  Bethlehem
 Lehigh Valley Hospital - Muhlenberg
 Alyson F McIntosh Ph: 610-402-2273
  East Stroudsburg
 Dale and Frances Hughes Cancer Center at Pocono Medical Center
 Norman G. Rosenblum Ph: 215-955-6084
  Pittsburgh
 UPMC Cancer Centers
 Robert P. Edwards Ph: 412-647-2811
  West Chester
 Cancer Center of Chester County
 William E. Luginbuhl Ph: 610-431-5297
South Carolina
  Easley
 Cancer Centers of the Carolinas - Easley
 Larry E Puls Ph: 864-241-6251
South Dakota
  Rapid City
 Rapid City Regional Hospital
 Helen L. Frederickson Ph: 605-343-9224
Tennessee
  Chattanooga
 Chattanooga's Program in Women's Oncology
 Stephen E DePasquale Ph: 423-266-3636
  Knoxville
 U.T. Medical Center Cancer Institute
 Larry C Kilgore Ph: 865-544-9773
Washington
  Auburn
 Auburn Regional Center for Cancer Care
 John A Keech Ph: 253-887-9333
  Bellevue
 Overlake Cancer Center at Overlake Hospital Medical Center
 John A Keech Ph: 253-887-9333
  Centralia
 Providence Centralia Hospital
 John A Keech Ph: 253-887-9333
  Longview
 Lower Columbia Regional Cancer Center at PeaceHealth-St. John Medical Center
 Alison K Conlin Ph: 503-215-6412
  Olympia
 Capital Medical Center
 John A Keech Ph: 253-887-9333
 Providence St. Peter Hospital Regional Cancer Center
 John A Keech Ph: 253-887-9333
  Puyallup
 Good Samaritan Cancer Center
 John A Keech Ph: 253-887-9333
  Tacoma
 Allenmore Hospital
 John A Keech Ph: 253-887-9333
 CCOP - Northwest
 John A Keech Ph: 253-887-9333
 MultiCare Regional Cancer Center at Tacoma General Hospital
 John A Keech Ph: 253-887-9333
 Northwest Medical Specialties, PLLC - Tacoma
 John A Keech Ph: 253-887-9333
West Virginia
  Huntington
 Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
 Maria-Rosalia B. Tria Tirona Ph: 304-399-6617
  Wheeling
 Schiffler Cancer Center at Wheeling Hospital
 Jon David Pollock Ph: 304-243-6442
Wisconsin
  Madison
 University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
 David M Kushner Ph: 877-405-6866
  New Richmond
 Cancer Center of Western Wisconsin
 Matthew P Boente Ph: 952-993-1517
  Email: MMCCOP@parknicollet.com
  Racine
 All Saints Cancer Center at Wheaton Franciscan Healthcare
 James H. Taylor Ph: 414-874-4541
  Email: Kelli.holton@wfhc.org
Republic of Korea
Kyeonggi-do
  Seongnam City
 Seoul National University Bundang Hospital
 Kidong Kim Ph: 011-82-02-9702-114

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00942357
ClinicalTrials.gov processed this data on August 07, 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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