Trial record 1 of 1 for:    GOG 0273
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Chemotherapy Toxicity On Quality of Life in Older Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01366183
First received: June 2, 2011
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

This trial studies the chemotherapy toxicity on quality of life in older patients with stage I, stage II, stage III, or stage IV ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer. Learning about the side effects of chemotherapy in older patients may help doctors plan better ways to treat cancer.


Condition Intervention
Stage I Ovarian Epithelial Cancer
Stage I Primary Peritoneal Cavity Cancer
Stage IA Fallopian Tube Cancer
Stage IB Fallopian Tube Cancer
Stage IC Fallopian Tube Cancer
Stage II Ovarian Epithelial Cancer
Stage II Primary Peritoneal Cavity Cancer
Stage IIA Fallopian Tube Cancer
Stage IIB Fallopian Tube Cancer
Stage IIC Fallopian Tube Cancer
Stage III Ovarian Epithelial Cancer
Stage III Primary Peritoneal Cavity Cancer
Stage IIIA Fallopian Tube Cancer
Stage IIIB Fallopian Tube Cancer
Stage IIIC Fallopian Tube Cancer
Stage IV Fallopian Tube Cancer
Stage IV Ovarian Epithelial Cancer
Stage IV Primary Peritoneal Cavity Cancer
Other: pharmacological study
Other: questionnaire administration
Procedure: assessment of therapy complications
Other: quality-of-life assessment
Drug: carboplatin
Drug: paclitaxel
Biological: filgrastim

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chemotherapy Toxicity in Elderly Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Tolerance to study treatment, defined as completing four cycles of study treatment, without dose reductions or treatment delays of over seven days [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    Will be modeled with logistic regression using baseline IADL scores as a covariate. Exploratory analysis will evaluate baseline IADL scores adjusting for covariates such as: Charlson scale, nutritional status, or age.

  • Percent of women, who are 70 years or older, able to complete at least 4 cycles of treatment regardless of dose reduction and delays [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    While this percentage will be estimated for each study regimen separately, the targeted sample size will limit the width of the 95%-confidence interval for the marginal percentage so that it is no larger than 0.15.


Secondary Outcome Measures:
  • Changes in quality-of-life measured by FACT-O, FACT/GOG-Ntx-4 subscale, IADL, and ADL [ Time Frame: Baseline to up to 6 weeks after completion of course 4 ] [ Designated as safety issue: No ]
    The changes in FACT-O, FACT/GOG-Ntx-4 subscale, IADL, and ADL will be summarized descriptively as the differences of scores between pre and post chemotherapy. Assuming 80% of patients complete the assessment at the completion of chemotherapy, then a sample of 148 patients will provide 90% power to detect 5 unit changes in FACT-O, 0.5 unit change in FACT/GOG-Ntx subscale score, 1 unit change in IADL or ADL score using paired t-test at significant level of 0.05.

  • Changes in comorbidity index measured by the Charlson scale [ Time Frame: Baseline to up to 6 weeks after completion of course 4 ] [ Designated as safety issue: No ]
  • Changes in nutritional status measured by weight [ Time Frame: Baseline to up to 6 weeks after completion of course 4 ] [ Designated as safety issue: No ]
    The changes in weight will be summarized descriptively as the differences of scores between pre and post chemotherapy. The change of nutritional status after completing chemotherapy will be examined using McNemar's test.

  • Clinical response of elderly patients with ovarian, primary peritoneal cavity, or fallopian tube cancer [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Percent of patients reporting adverse events as assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events [ Time Frame: Up to 6 weeks after course 4 ] [ Designated as safety issue: Yes ]
    The probability of an adverse event will be estimated as the percent of patients reporting an adverse event out of all patients beginning treatment.


Other Outcome Measures:
  • Pharmacokinetic parameters including paclitaxel AUC, carboplatin AUC, paclitaxel total body clearance, and time that plasma paclitaxel concentration remains above threshold 0.05 uM/L [ Time Frame: Pre-dose, 1, 6, and 24 hours ] [ Designated as safety issue: No ]
    The observed pharmacokinetics of paclitaxel and carboplatin will be compared with published pharmacokinetic measures of paclitaxel and carboplatin in a descriptive fashion. No formal statistical testing will be performed for the comparisons.


Estimated Enrollment: 290
Study Start Date: August 2011
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observational (quality of life questionnaire)

Patients receive chemotherapy comprising carboplatin, paclitaxel, and filgrastim (regimen 1) or carboplatin alone (regimen 2) every 21 days for 4 courses according to their physicians and/or patients' choice. Patients may undergo surgery and/or further chemotherapy at the discretion of treating physician. Patients undergo blood sample collection at baseline and periodically during course 1 for pharmacokinetic studies.

Patients' quality of life is assessed by the FACT-O, the FACT-Ntx subscale, the IADL, and the Ability to Complete Social Activity questionnaires at baseline, prior to courses 1 and 3, and then 3-6 weeks after completion of course 4. Nutritional status, such as body mass index and weight loss, and comorbidity and hearing impairment are also assessed.

Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: questionnaire administration
Ancillary studies
Procedure: assessment of therapy complications
Undergo nutritional status, such as body mass index and weight loss, and comorbidity and hearing impairment assessments
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Drug: carboplatin
Undergo chemotherapy
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Drug: paclitaxel
Undergo chemotherapy
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Biological: filgrastim
Undergo chemotherapy
Other Names:
  • G-CSF
  • Neupogen

Detailed Description:

PRIMARY OBJECTIVES:

l. To determine whether the score on Instrumental Activities of Daily Living (IADL) obtained prior to treatment is associated with the ability of patients to complete four cycles of chemotherapy without dose reduction or a more than 7-day delay.

II. To estimate by regimen the percentage of patients who are able to complete four cycles of chemotherapy regardless of dose reductions and delays.

III. To compare actual and calculated carboplatin area under the curve (AUC) in this patient population.

SECONDARY OBJECTIVES:

I. To describe the percentage of patients who are entered after primary surgery versus those entered to receive primary or neoadjuvant chemotherapy, the percentage of patients who are treated with each allowed regimen, and the percentage of patients who eventually receive surgery in the primary chemotherapy group.

II. To determine whether the need for assistance with IADLs at time of registration is associated with choice of chemotherapy regimen (in both primary chemotherapy and primary surgery patients).

III. To explore whether age, baseline scores on the geriatric measures (functional status, nutritional status, or co-morbidity) and quality-of-life (QOL) are correlated with likelihood of completing four courses of chemotherapy without dose reduction or a more than 7-day delay.

IV. To explore reasons for and timing of dose reductions and delays. V. To describe toxicities, pre-/post-chemotherapy QOL, and pre-/post-chemotherapy scores on geriatric measures in this patient population.

TERTIARY OBJECTIVES:

I. To explore potential relationships of carboplatin AUC, paclitaxel clearance, and paclitaxel time above a plasma concentration of 0.05 mcM to nadir neutrophil and platelet counts during course 1 of treatment.

II. To explore the association between baseline IADL and survival. III. To explore the association between IADL and the functional well-being (FWB) subscale in the Functional Assessment of Cancer Therapy - Ovary (FACT-O).

OUTLINE:

Patients receive chemotherapy comprising carboplatin, paclitaxel, and filgrastim (regimen 1) or carboplatin alone (regimen 2) every 21 days for 4 courses according to their physicians and/or patients' choice. Patients may undergo surgery and/or further chemotherapy at the discretion of treating physician. Patients undergo blood sample collection at baseline and periodically during course 1 for pharmacokinetic studies.

Patients' quality of life is assessed by the FACT-O, the Functional Assessment of Cancer Treatment - Neurotoxicity (FACT-Ntx subscale), the IADL, and the Ability to Complete Social Activity questionnaires at baseline, prior to courses 1 and 3, and then 3-6 weeks after completion of course 4. Nutritional status, such as body mass index and weight loss, and comorbidity and hearing impairment are also assessed.

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Elderly woman with ovarian, fallopian tube or primary peritoneal cancer

Criteria

Inclusion Criteria:

  • Eligible patients must have a histologically or cytologically confirmed diagnosis of adenocarcinoma of the ovary, peritoneum, or fallopian tube either by surgery, biopsy, fine-needle aspiration (FNA), paracentesis, or thoracentesis; a diagnosis of a mucinous cancer must be made by biopsy only
  • International Federation of Gynecology and Obstetrics (FIGO) stage I, II, III, and IV are eligible
  • Patients must have received no previous treatment for this malignancy other than surgery
  • Patients must be entered within eight weeks of confirmation of disease diagnosis by surgery, biopsy, FNA, paracentesis or thoracentesis if there is no primary surgery, and within twelve weeks of primary or staging surgery if patient received primary surgery
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl
  • Platelets greater than or equal to 100,000/mcl
  • Bilirubin less than or equal upper limit of normal (ULN)
  • Creatinine less than or equal to 1.5 x ULN
  • Patients must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, 2 or 3
  • Effective XX/XX/2014, only patients 75 years of age or older are eligible for enrollment; (04/23/2012) (08/12/2013)
  • Patients must have recovered from the effects of recent surgery
  • Patients must be free of active infection requiring antibiotics
  • Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA)
  • Patient and physician agree that they plan to conduct treatment according to Regimen 3
  • Patient can read and understand sufficient English to be able to respond to questions posed by the study instruments

Exclusion Criteria:

  • Patients who have received previous treatment for this malignancy other than surgery
  • Patients with other invasive malignancies whose previous cancer treatment contraindicates this protocol therapy
  • "Borderline tumors" (tumors of low malignant potential) by surgery or biopsy are excluded
  • Patients with medical conditions that in the opinion of the investigator render treatment on this protocol unsafe should be excluded
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366183

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
Gynecologic Oncology Group of Arizona
Phoenix, Arizona, United States, 85012
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Arizona Cancer Center at University Medical Center North
Tucson, Arizona, United States, 85719
United States, California
John Muir Medical Center-Concord Campus
Concord, California, United States, 94520
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States, 94040
University of California Medical Center At Irvine-Orange Campus
Orange, California, United States, 92868
Saint Joseph Hospital - Orange
Orange, California, United States, 92868
UCSF-Mount Zion
San Francisco, California, United States, 94115
Stanford University Hospitals and Clinics
Stanford, California, United States, 94305
Olive View-University of California Los Angeles Medical Center
Sylmar, California, United States, 91342
United States, Colorado
Rocky Mountain Gynecologic Oncology PC
Englewood, Colorado, United States, 80110
United States, Connecticut
Danbury Hospital
Danbury, Connecticut, United States, 06810
Hartford Hospital
Hartford, Connecticut, United States, 06102
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
Middlesex Hospital
Middletown, Connecticut, United States, 06457
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
Yale University
New Haven, Connecticut, United States, 06520
Stamford Hospital/Bennett Cancer Center
Stamford, Connecticut, United States, 06904
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
Christiana Gynecologic Oncology LLC
Newark, Delaware, United States, 19713
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, United States, 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States, 19713
Regional Hematology and Oncology PA
Newark, Delaware, United States, 19713
Helen F Graham Cancer Center
Newark, Delaware, United States, 19713
Beebe Health Campus
Rehoboth Beach, Delaware, United States, 19971
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States, 19801
United States, Florida
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
Florida Gynecologic Oncology
Fort Myers, Florida, United States, 33905
Jupiter Medical Center
Jupiter, Florida, United States, 33458
Mercy Hospital
Miami, Florida, United States, 33133
Mount Sinai Medical Center CCOP
Miami Beach, Florida, United States, 33140
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Georgia Regents University
Augusta, Georgia, United States, 30912
John B Amos Cancer Center
Columbus, Georgia, United States, 31904
Dekalb Medical Center
Decatur, Georgia, United States, 30033
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Memorial Health University Medical Center
Savannah, Georgia, United States, 31403
Saint Joseph's-Candler Health System
Savannah, Georgia, United States, 31405
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States, 83706
United States, Illinois
Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Northwestern University
Chicago, Illinois, United States, 60611
University of Chicago
Chicago, Illinois, United States, 60637
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, United States, 60521
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States, 62864
West Suburban Medical Center
River Forest, Illinois, United States, 60305
Cadence Cancer Center in Warrenville
Warrenville, Illinois, United States, 60555
United States, Indiana
Saint Francis Hospital and Health Centers
Beech Grove, Indiana, United States, 46107
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, United States, 46514
Elkhart Clinic
Elkhart, Indiana, United States, 46514-2098
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Saint Vincent Oncology Center
Indianapolis, Indiana, United States, 46260
Franciscan Saint Francis Health-Indianapolis
Indianapolis, Indiana, United States, 46237
Community Howard Regional Health
Kokomo, Indiana, United States, 46904
IU Health La Porte Hospital
La Porte, Indiana, United States, 46350
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States, 46545-1470
Cancer Care Partners LLC
Mishawaka, Indiana, United States, 46545
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States, 46545-1470
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, United States, 46563
Reid Hospital and Health Care Services
Richmond, Indiana, United States, 47374
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States, 46601
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46628
South Bend Clinic
South Bend, Indiana, United States, 46617
Michiana Hematology Oncology-PC Westville
Westville, Indiana, United States, 46391
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States, 50010
Mary Greeley Medical Center
Ames, Iowa, United States, 50010
McFarland Clinic PC-Boone
Boone, Iowa, United States, 50036
Cedar Rapids Oncology Association
Cedar Rapids, Iowa, United States, 52403
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Mercy Hospital
Cedar Rapids, Iowa, United States, 52403
Mercy Cancer Center-West Lakes
Clive, Iowa, United States, 50325
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States, 50325
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Iowa Oncology Research Association CCOP
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States, 50314
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
McFarland Clinic PC-Jefferson
Jefferson, Iowa, United States, 50129
McFarland Clinic PC-Marshalltown
Marshalltown, Iowa, United States, 50158
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States, 51101
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States, 51104
Mercy Medical Center-West Lakes
West Des Moines, Iowa, United States, 50266
Methodist West Hospital
West Des Moines, Iowa, United States, 50266-7700
United States, Kansas
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Providence Medical Center
Kansas City, Kansas, United States, 66112
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States, 67901
Cancer Center of Kansas-Manhattan
Manhattan, Kansas, United States, 66502
Cancer Center of Kansas - McPherson
McPherson, Kansas, United States, 67460
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Saint Luke's South Hospital
Overland Park, Kansas, United States, 66213
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
Kansas City CCOP
Prairie Village, Kansas, United States, 66208
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Stormont-Vail Regional Health Center
Topeka, Kansas, United States, 66604
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Wichita CCOP
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States, 67214
Associates In Womens Health
Wichita, Kansas, United States, 67208
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Kentucky
Oncology Hematology Care Incorporated
Crestview Hills, Kentucky, United States, 41017
Saint Elizabeth Medical Center South
Edgewood, Kentucky, United States, 41017
Baptist Health Lexington
Lexington, Kentucky, United States, 40503
Norton Health Care Pavilion - Downtown
Louisville, Kentucky, United States, 40202
United States, Louisiana
Woman's Hospital
Baton Rouge, Louisiana, United States, 70817
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States, 70121
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Maine
Harold Alfond Center for Cancer Care
Augusta, Maine, United States, 04330
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Maine Medical Center-Bramhall Campus
Portland, Maine, United States, 04102
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Union Hospital of Cecil County
Elkton MD, Maryland, United States, 21921
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
Beth Israel Deaconess Hospital-Plymouth
Plymouth, Massachusetts, United States, 02360
University of Massachusetts Memorial Health Care
Worcester, Massachusetts, United States, 01605
United States, Michigan
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, United States, 48106
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48124
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States, 49431
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States, 48532
Hurley Medical Center
Flint, Michigan, United States, 48502
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States, 49801
Allegiance Health
Jackson, Michigan, United States, 49201
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States, 48060
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States, 49085
Providence Hospital
Southfield, Michigan, United States, 48075
Lakeland Hospital
St. Joseph, Michigan, United States, 49085
William Beaumont Hospital - Troy
Troy, Michigan, United States, 48098
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, United States, 56601
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, United States, 55455
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
New Ulm Medical Center
New Ulm, Minnesota, United States, 56073
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Mayo Clinic
Rochester, Minnesota, United States, 55905
Park Nicollet Frauenshuh Cancer Center
Saint Louis Park, Minnesota, United States, 55426
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Missouri
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, United States, 64118
Research Medical Center
Kansas City, Missouri, United States, 64132
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Saint Luke's Cancer Institute
Kansas City, Missouri, United States, 64111
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States, 64086
Liberty Hospital
Liberty, Missouri, United States, 64068
Saint John's Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States, 65401
Saint Joseph Oncology Inc
Saint Joseph, Missouri, United States, 64507
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64506
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield
Springfield, Missouri, United States, 65804
United States, Montana
Billings Clinic
Billings, Montana, United States, 59107-7000
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, United States, 59102
Montana Cancer Consortium CCOP
Billings, Montana, United States, 59101
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States, 59701
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Great Falls Clinic
Great Falls, Montana, United States, 59405
Northern Montana Hospital
Havre, Montana, United States, 59501
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Glacier Oncology PLLC
Kalispell, Montana, United States, 59901
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States, 59802
Montana Cancer Specialists
Missoula, Montana, United States, 59802
United States, Nebraska
Good Samaritan Hospital
Kearney, Nebraska, United States, 68847
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
United States, Nevada
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89169
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Hackensack University Medical CCOP
Hackensack, New Jersey, United States, 07601
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
Mount Holly, New Jersey, United States, 08060
UMDNJ - New Jersey Medical School
Newark, New Jersey, United States, 07103
Virtua West Jersey Hospital Voorhees
Voorhees, New Jersey, United States, 08043
United States, New Mexico
Southwest Gynecologic Oncology Associates Inc
Albuquerque, New Mexico, United States, 87106
University of New Mexico
Albuquerque, New Mexico, United States, 87106
United States, New York
Women's Cancer Care Associates LLC
Albany, New York, United States, 12208
State University of New York Downstate Medical Center
Brooklyn, New York, United States, 11203
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Glens Falls Hospital
Glens Falls, New York, United States, 12801
North Shore University Hospital
Manhasset, New York, United States, 11030
North Shore-LIJ Health System/Center for Advanced Medicine
New Hyde Park, New York, United States, 11040
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
New York University Langone Medical Center
New York, New York, United States, 10016
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Columbia University Medical Center
New York, New York, United States, 10032
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Cone Health Alamance Regional Medical Center
Burlington, North Carolina, United States, 27216
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States, 28204
Carolinas Medical Center - Northeast
Concord, North Carolina, United States, 28025
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wayne Memorial Hospital
Goldsboro, North Carolina, United States, 27534
Duke Raleigh Hospital
Raleigh, North Carolina, United States, 27609
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
Mid Dakota Clinic
Bismarck, North Dakota, United States, 58501
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States, 58501
Saint Alexius Medical Center
Bismarck, North Dakota, United States, 58501
Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
Sanford Clinic North-Fargo
Fargo, North Dakota, United States, 58122
Sanford Medical Center-Fargo
Fargo, North Dakota, United States, 58122
United States, Ohio
Akron General Medical Center
Akron, Ohio, United States, 44307
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
Strecker Cancer Center-Belpre
Belpre, Ohio, United States, 45714
Aultman Health Foundation
Canton, Ohio, United States, 44710
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Bethesda North Hospital
Cincinnati, Ohio, United States, 45242
Oncology and Hematology Care Incorporated
Cincinnati, Ohio, United States, 45219
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, United States, 45220
Oncology Hematology Care Inc - Kenwood
Cincinnati, Ohio, United States, 45236
Oncology Hematology Care Inc - Western Hills
Cincinnati, Ohio, United States, 45248
Oncology and Hematology Care Inc - Blue Ash
Cincinnati, Ohio, United States, 45242
Oncology Hematology Care Inc - Anderson
Cincinnati, Ohio, United States, 45230
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
The Mark H Zangmeister Center
Columbus, Ohio, United States, 43219
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Doctors Hospital
Columbus, Ohio, United States, 43228
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, United States, 43214
Grant Medical Center
Columbus, Ohio, United States, 43215
Columbus CCOP
Columbus, Ohio, United States, 43215
Mount Carmel East Hospital
Columbus, Ohio, United States, 43213
Mount Carmel Health Center West
Columbus, Ohio, United States, 43222
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Samaritan North Health Center
Dayton, Ohio, United States, 45415
Grandview Hospital
Dayton, Ohio, United States, 45405
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States, 45406
Dayton CCOP
Dayton, Ohio, United States, 45420
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Delaware Radiation Oncology
Delaware, Ohio, United States, 43015
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, United States, 43015
Oncology Hematology Care Inc
Fairfield, Ohio, United States, 45014
Blanchard Valley Hospital
Findlay, Ohio, United States, 45840
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Wayne Hospital
Greenville, Ohio, United States, 45331
Lancaster Radiation Oncology
Lancaster, Ohio, United States, 43130
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States, 44124
Lake University Ireland Cancer Center
Mentor, Ohio, United States, 44060
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
Licking Memorial Hospital
Newark, Ohio, United States, 43055
Newark Radiation Oncology
Newark, Ohio, United States, 43055
Southern Ohio Medical Center
Portsmouth, Ohio, United States, 45662
Springfield Regional Medical Center
Springfield, Ohio, United States, 45505
Upper Valley Medical Center
Troy, Ohio, United States, 45373
Saint Ann's Hospital
Westerville, Ohio, United States, 43081
Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Genesis HealthCare System
Zanesville, Ohio, United States, 43701
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Warren Clinic-Tulsa South
Tulsa, Oklahoma, United States, 74136
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa, Oklahoma, United States, 74136
Oklahoma Oncology Inc
Tulsa, Oklahoma, United States, 74104
Warren Cancer Research Foundation
Tulsa, Oklahoma, United States, 74136
Tulsa Cancer Institute
Tulsa, Oklahoma, United States, 74146
United States, Pennsylvania
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, United States, 18015
Adams Cancer Center
Gettysburg, Pennsylvania, United States, 17325
Cherry Tree Cancer Center
Hanover, Pennsylvania, United States, 17331
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15232
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, United States, 18840
Chester County Hospital
West Chester, Pennsylvania, United States, 19380
Reading Hospital
West Reading, Pennsylvania, United States, 19611
WellSpan Health-York Hospital
York, Pennsylvania, United States, 17405
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
United States, Tennessee
University of Tennessee - Knoxville
Knoxville, Tennessee, United States, 37920
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Scott and White Memorial Hospital
Temple, Texas, United States, 76508
United States, Vermont
Fletcher Allen Health Care-Medical Center
Burlington, Vermont, United States, 05401
United States, Virginia
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, United States, 24016
United States, West Virginia
Monongalia Hospital
Morgantown, West Virginia, United States, 26505
United States, Wisconsin
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, United States, 54701
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Gundersen Lutheran
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States, 54221
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States, 54548
D N Greenwald Center
Mukwonago, Wisconsin, United States, 53149
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States, 54017
Oconomowoc Memorial Hospital-ProHealth Care Inc
Oconomowoc, Wisconsin, United States, 53066-3896
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States, 54904
Marshfield Clinic at James Beck Cancer Center
Rhinelander, Wisconsin, United States, 54501
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, United States, 54868
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, United States, 53081
Marshfield Clinic Cancer Care at Saint Michael's Hospital
Stevens Point, Wisconsin, United States, 54481
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Aurora Medical Center in Summit
Summit, Wisconsin, United States, 53066
Waukesha Memorial Hospital - ProHealth Care
Waukesha, Wisconsin, United States, 53188
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, United States, 54401
Aurora West Allis Medical Center
West Allis, Wisconsin, United States, 53227
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States, 54494
United States, Wyoming
Rocky Mountain Oncology
Casper, Wyoming, United States, 82609
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Vivian von Gruenigen Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01366183     History of Changes
Other Study ID Numbers: GOG-0273, NCI-2011-02900, GOG-0273, GOG-0273, GOG-0273, U10CA101165
Study First Received: June 2, 2011
Last Updated: August 8, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Ovarian Diseases
Endocrine System Diseases
Gonadal Disorders
Carboplatin
Paclitaxel
Lenograstim
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on September 14, 2014