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Combination Chemotherapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer
This study is ongoing, but not recruiting participants.
First Received: March 3, 2001   Last Updated: July 21, 2009   History of Changes
Sponsor: Gynecologic Oncology Group
Collaborators: National Cancer Institute (NCI)
Southwest Oncology Group
Medical Research Council
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00011986
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is most effective in treating ovarian epithelial cancer and peritoneal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have stage III or stage IV ovarian cancer or primary peritoneal cancer.


Condition Intervention Phase
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: carboplatin
Drug: gemcitabine hydrochloride
Drug: paclitaxel
Drug: pegylated liposomal doxorubicin hydrochloride
Drug: topotecan hydrochloride
Procedure: adjuvant therapy
Procedure: conventional surgery
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Phase III Randomized Trial Of Paclitaxel And Carboplatin Versus Triplet Or Sequential Doublet Combinations In Patients With Epithelial Ovarian Or Primary Peritoneal Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2001
Detailed Description:

OBJECTIVES:

  • Compare the efficacy of paclitaxel and carboplatin with or without gemcitabine, doxorubicin HCl liposome, or topotecan, in terms of overall and progression-free survival, in patients with stage III or IV ovarian epithelial or serous primary peritoneal carcinoma.
  • Determine the response rate in patients with measurable disease treated with these regimens.
  • Compare the toxic effects of these regimens in these patients.
  • Compare the complications in patients treated with these regimens.
  • Determine the dose-intensity and cumulative dose delivery for these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified into 1 of 3 strata according to extent of residual disease and plans for interval cytoreductive surgery:

  • Stratum A: Optimal (microscopic or macroscopic) residual disease without plans for surgery
  • Stratum B: Suboptimal residual disease without plans for surgery
  • Stratum C: Suboptimal residual disease with plans for surgery Patients are randomized to 1 of 5 treatment arms.
  • Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment continues every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive chemotherapy as in arm I and gemcitabine IV over 30 minutes on days 1 and 8. Treatment continues as in arm I.
  • Arm III: Patients receive chemotherapy as in arm I during courses 1-8 and doxorubicin HCl liposome IV over 1 hour on day 1 during courses 1, 3, 5, and 7. Treatment continues as in arm I.
  • Arm IV: Patients receive topotecan IV over 30 minutes on days 1-3 and carboplatin IV over 30 minutes on day 3. Treatment continues every 3 weeks for 4 courses. Patients then receive 4 courses of arm I chemotherapy.
  • Arm V: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 8. Treatment continues every 3 weeks for 4 courses. Patients then receive 4 courses of arm I chemotherapy.

Patients with initial unresectable or suboptimal residual disease (more than 1 cm) may undergo interval cytoreductive surgery between courses 4 and 5 of chemotherapy.

Patients are followed every 3 months for 2 years and then every 6 months.

PROJECTED ACCRUAL: Approximately 4,000-5,000 patients (800-1,000 per treatment arm) will be accrued for this study within 3.5-5 years.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage III or IV ovarian epithelial or serous primary peritoneal carcinoma
  • The following are ineligible:

    • Germ cell tumors
    • Sex cord-stromal tumors
    • Carcinosarcomas
    • Mixed Mullerian tumors or carcinosarcomas
    • Metastatic carcinomas from other sites to the ovary
    • Low malignant potential tumors, including micropapillary serous carcinomas
    • Mucinous primary peritoneal carcinoma
  • Prior ovarian low malignant potential tumor (borderline carcinoma) that was surgically resected with subsequent development of invasive adenocarcinoma allowed if no prior chemotherapy
  • Optimal (no greater than 1 cm) or suboptimal residual disease after initial surgery
  • Prior breast cancer allowed provided the following are true:

    • Disease-free for more than 5 years
    • No prior cytotoxic chemotherapy for breast cancer
  • Prior or concurrent primary endometrial cancer allowed if the following conditions are met:

    • Stage no greater than IB
    • Less than 3 mm invasion without vascular or lymphatic invasion
    • No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesions

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • GOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST no greater than 2.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN
  • No acute hepatitis

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No unstable angina
  • No myocardial infarction within the past 6 months
  • No evidence of abnormal cardiac conduction (e.g., bundle branch block, heart block) unless stable for the past 6 months

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No greater than grade 1 sensory or motor neuropathy
  • No active infection that requires antibiotics
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No severe or ongoing gastrointestinal bleeding that requires blood product support

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • Prior chemotherapy for cancer involving the abdominal cavity or pelvis allowed provided the following are true:

    • More than 3 years since prior therapy
    • No evidence of recurrent disease

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy to any portion of the abdominal cavity or pelvis
  • Prior radiotherapy for localized breast, head and neck, or skin cancer allowed provided the following are true:

    • More than 3 years since prior therapy
    • No evidence of recurrent disease

Surgery:

  • See Disease Characteristics
  • No more than 12 weeks since prior surgical resection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00011986

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Locations
United States, Alabama
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36607
United States, Alaska
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99519-6604
United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States, 85006-2726
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, United States, 85012
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States, 85723
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, United States, 72205
United States, California
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95403
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, United States, 92868
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033
David Grant Medical Center
Travis Air Force Base, California, United States, 94535
University of California Davis Cancer Center
Sacramento, California, United States, 95817
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States, 94553
United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80010
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States, 80220
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, District of Columbia
MBCCOP - Howard University Cancer Center
Washington, District of Columbia, United States, 20060
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5001
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, United States, 33612
United States, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
United States, Hawaii
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153-5500
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
Rush University Medical Center
Chicago, Illinois, United States, 60612-3824
CCOP - Evanston
Evanston, Illinois, United States, 60201
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States, 60612
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States, 60612
Veterans Affairs Medical Center - Hines (Edward Hines, Junior Hospital)
Hines, Illinois, United States, 60141
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
United States, Iowa
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States, 52722
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7353
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States, 67218
United States, Kentucky
Cancer Center at Lexington Clinic
Lexington, Kentucky, United States, 40504
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0084
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States, 40502-2236
United States, Louisiana
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, United States, 70112
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Tulane Cancer Center at Tulane University Hospital and Clinic
New Orleans, Louisiana, United States, 70112
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States, 71130-3932
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, United States, 71101-4295
United States, Massachusetts
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States, 02118
Tufts - New England Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
CCOP - Beaumont
Royal Oak, Michigan, United States, 48073-6769
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
Providence Cancer Institute at Providence Hospital
Southfield, Michigan, United States, 48075
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0912
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, United States, 48105
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States, 48201-1932
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905-0001
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, United States, 39216
United States, Missouri
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
CCOP - St. Louis-Cape Girardeau
Saint Louis, Missouri, United States, 63141
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
St. Louis University Hospital Cancer Center
Saint Louis, Missouri, United States, 63110
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103-1489
United States, New Mexico
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States, 87131
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, United States, 87108-5138
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
North Shore University Hospital
Manhasset, New York, United States, 11030
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States, 27534-9479
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Veterans Affairs Medical Center - Salisbury
Salisbury, North Carolina, United States, 28144
United States, Ohio
Arthur G. James Cancer Hospital at Ohio State University
Columbus, Ohio, United States, 43210-1240
CCOP - Columbus
Columbus, Ohio, United States, 43206
Ireland Cancer Center
Cleveland, Ohio, United States, 44106
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267-0501
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195-9001
CCOP - Dayton
Dayton, Ohio, United States, 45429
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, United States, 45220-2288
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428-1002
United States, Oregon
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97201-3098
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
Veterans Affairs Medical Center - Portland
Portland, Oregon, United States, 97207
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001-3788
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States, 17822-2001
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213-3180
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, United States, 29401-5799
United States, Tennessee
Gynecologic Oncology Network
Nashville, Tennessee, United States, 37203
Southeast Gynecologic Oncology Associates
Knoxville, Tennessee, United States, 37917
University of Tennessee Cancer Institute
Memphis, Tennessee, United States, 38104
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232-2516
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234-6200
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Harrington Cancer Center
Amarillo, Texas, United States, 79106
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0587
Veterans Affairs Medical Center - Amarillo
Amarillo, Texas, United States, 79106
Veterans Affairs Medical Center - Houston
Houston, Texas, United States, 77030
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States, 78229
Veterans Affairs Medical Center - Temple
Temple, Texas, United States, 76504
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112-5550
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, United States, 84148
United States, Washington
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
CCOP - Virginia Mason Research Center
Seattle, Washington, United States, 98101
Madigan Army Medical Center
Tacoma, Washington, United States, 98431-5000
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98104
Tacoma General Hospital
Tacoma, Washington, United States, 98405
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States, 98108
United States, Wisconsin
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
Italy
European Institute of Oncology
Milano, Italy, 20141
United Kingdom, England
Medical Research Council Clinical Trials Unit
London, England, United Kingdom, NW1 2DA
Sponsors and Collaborators
Gynecologic Oncology Group
Southwest Oncology Group
Medical Research Council
Investigators
Study Chair: Michael A. Bookman, MD Fox Chase Cancer Center
Investigator: William P. McGuire, MD Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
Study Chair: Amy D. Tiersten, MD Herbert Irving Comprehensive Cancer Center
Study Chair: Helen Pearce, PhD Medical Research Council
  More Information

Additional Information:
Publications:
Bookman MA: GOG0182-ICON5: 5-arm phase III randomized trial of paclitaxel (P) and carboplatin (C) vs combinations with gemcitabine (G), PEG-lipososomal doxorubicin (D), or topotecan (T) in patients (pts) with advanced-stage epithelial ovarian (EOC) or primary peritoneal (PPC) carcinoma. [Abstract] J Clin Oncol 24 (Suppl 18): A-5002, 256s, 2006.
Bookman MA, Brady MF, McGuire WP, Harper PG, Alberts DS, Friedlander M, Colombo N, Fowler JM, Argenta PA, De Geest K, Mutch DG, Burger RA, Swart AM, Trimble EL, Accario-Winslow C, Roth LM. Evaluation of new platinum-based treatment regimens in advanced-stage ovarian cancer: a Phase III Trial of the Gynecologic Cancer Intergroup. J Clin Oncol. 2009 Mar 20;27(9):1419-25. Epub 2009 Feb 17.
Bookman MA, Greer BE, Ozols RF. Optimal therapy of advanced ovarian cancer: carboplatin and paclitaxel vs. cisplatin and paclitaxel (GOG 158) and an update on GOG0 182-ICON5. Int J Gynecol Cancer. 2003 Nov-Dec;13(6):735-40.
Copeland LJ, Bookman M, Trimble E; Gynecologic Oncology Group Protocol GOG 182-ICON5. Clinical trials of newer regimens for treating ovarian cancer: the rationale for Gynecologic Oncology Group Protocol GOG 182-ICON5. Gynecol Oncol. 2003 Aug;90(2 Pt 2):S1-7.
Krivak TC, Darcy KM, Tian C, et al.: Relationship between ERCC1 polymorphisms, disease progression, and survivalin GOG0182, a Gynecologic Oncology Group phase III trial of platinum-based chemotherapy in women with advanced stage epithelial ovarian or primary peritoneal cancer. [Abstract] J Clin Oncol 26 (Suppl 15): A-5540, 2008.
Darcy KM, Tian C, Ambrosone CB, et al.: A Gynecologic Oncology Group study of associations between polymorphisms in ABC transporter genes (ABCB1, ABCC2, and ABCG2) and outcome in advanced stage epithelial ovarian cancer treated with platinum and taxane chemotherapy. [Abstract] J Clin Oncol 27 (Suppl 15): A-5567, 2009.
Baysal BE, DeLoia JA, Willett-Brozick JE, Goodman MT, Brady MF, Modugno F, Lynch HT, Conley YP, Watson P, Gallion HH. Analysis of CHEK2 gene for ovarian cancer susceptibility. Gynecol Oncol. 2004 Oct;95(1):62-9.

Study ID Numbers: CDR0000068467, GOG-0182, SWOG-G0182, MRC-ICON5, ECOG-G0182, ISRCTN41636183
Study First Received: March 3, 2001
Last Updated: July 21, 2009
ClinicalTrials.gov Identifier: NCT00011986     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
peritoneal cavity cancer

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Ovarian Diseases
Antibiotics, Antineoplastic
Genital Diseases, Female
Neoplasms by Site
Therapeutic Uses
Peritoneal Diseases
Gemcitabine
Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Mitosis Modulators
Genital Neoplasms, Female
Endocrine System Diseases
Enzyme Inhibitors
Antimitotic Agents
Carboplatin
Abdominal Neoplasms
Immunosuppressive Agents
Antiviral Agents
Doxorubicin
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009