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| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00064077 |
Purpose
RATIONALE: Drugs used in chemotherapy such as cisplatin, paclitaxel, vinorelbine, gemcitabine, and topotecan, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen containing cisplatin is most effective in treating cervical cancer.
PURPOSE: This randomized phase III trial is studying four combination chemotherapy regimens using cisplatin to compare how well they work in treating women with stage IVB, recurrent, or persistent cancer of the cervix.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer |
Drug: cisplatin Drug: gemcitabine hydrochloride Drug: paclitaxel Drug: topotecan hydrochloride Drug: vinorelbine ditartrate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Randomized Phase III Trial Of Paclitaxel Plus Cisplatin Versus Vinorelbine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Versus Topotecan Plus Cisplatin In Stage IVB, Recurrent Or Persistent Carcinoma of the Cervix |
| Estimated Enrollment: | 600 |
| Study Start Date: | July 2003 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 4 treatment arms.
In all arms, treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before courses 2 and 5, and at 9 months after study entry.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 600 patients (150 per treatment arm) will be accrued for this study within 4 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
At least 1 unidimensionally measurable lesion
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arkansas | |
| Highlands Oncology Group - Fayetteville | |
| Fayetteville, Arkansas, United States, 72703 | |
| Washington Regional Medical Center | |
| Fayetteville, Arkansas, United States, 72703 | |
| United States, California | |
| Cancer Center of Santa Barbara | |
| Snata Barbara, California, United States, 93105 | |
| Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | |
| Orange, California, United States, 92868 | |
| Santa Barbara Hematology Oncology Medical Group at Cancer Center of Santa Barbara | |
| Santa Barbara, California, United States, 93105 | |
| Moores UCSD Cancer Center | |
| La Jolla, California, United States, 92093-0658 | |
| Providence Saint Joseph Medical Center - Burbank | |
| Burbank, California, United States, 91505 | |
| Sansum Medical Clinic | |
| Santa Barbara, California, United States, 93105 | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Stanford Comprehensive Cancer Center - Stanford | |
| Stanford, California, United States, 94305 | |
| Todd Cancer Institute at Long Beach Memorial Medical Center | |
| Long Beach, California, United States, 90801 | |
| Torrance Memorial Medical Center | |
| Torrance, California, United States, 90509 | |
| UCSF Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90089-9181 | |
| United States, Colorado | |
| Colorado Gynecologic Oncology Group P.C. | |
| Aurora, Colorado, United States, 80010 | |
| United States, Connecticut | |
| George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | |
| New Britain, Connecticut, United States, 06050 | |
| Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | |
| Hartford, Connecticut, United States, 06105 | |
| Yale Cancer Center | |
| New Haven, Connecticut, United States, 06520-8028 | |
| United States, Delaware | |
| CCOP - Christiana Care Health Services | |
| Newark, Delaware, United States, 19713 | |
| United States, Florida | |
| Ella Milbank Foshay Cancer Center at Jupiter Medical Center | |
| Jupiter, Florida, United States, 33458 | |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | |
| Orlando, Florida, United States, 32803-1273 | |
| M.D. Anderson Cancer Center at Orlando | |
| Orlando, Florida, United States, 32806 | |
| Mayo Clinic - Jacksonville | |
| Jacksonville, Florida, United States, 32224 | |
| University of Miami Sylvester Comprehensive Cancer Center | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | |
| Savannah, Georgia, United States, 31403-3089 | |
| United States, Illinois | |
| Northwest Community Hospital | |
| Arlington Heights, Illinois, United States, 60005 | |
| Chicago Gynecologic Oncology | |
| Palatine, Illinois, United States, 60067 | |
| Hinsdale Hematology Oncology Associates | |
| Hinsdale, Illinois, United States, 60521 | |
| Ingalls Cancer Care Center at Ingalls Memorial Hospital | |
| Harvey, Illinois, United States, 60426 | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Regional Cancer Center at Memorial Medical Center | |
| Springfield, Illinois, United States, 62781-0001 | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, Indiana | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | |
| La Porte, Indiana, United States, 46350 | |
| Reid Hospital & Health Care Services, Incorporated | |
| Richmond, Indiana, United States, 47374 | |
| Howard Community Hospital at Howard Regional Health System | |
| Kokomo, Indiana, United States, 46904 | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| Memorial Hospital of South Bend | |
| South Bend, Indiana, United States, 46601 | |
| Elkhart General Hospital | |
| Elkhart, Indiana, United States, 46515 | |
| St. Francis Hospital and Health Centers - Beech Grove Campus | |
| Beech Grove, Indiana, United States, 46107 | |
| United States, Iowa | |
| Holden Comprehensive Cancer Center at University of Iowa | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kentucky | |
| Esther Marie Hatton Cancer Care Center at St. Elizabeth Medical Center | |
| Edgewood, Kentucky, United States, 41017 | |
| James Graham Brown Cancer Center at University of Louisville | |
| Louisville, Kentucky, United States, 40202 | |
| Louisville Oncology at Norton Cancer Center | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Louisiana | |
| CCOP - Ochsner | |
| New Orleans, Louisiana, United States, 70121 | |
| Ochsner Cancer Institute at Ochsner Clinic Foundation | |
| New Orleans, Louisiana, United States, 70121 | |
| Woman's Hospital | |
| Baton Rouge, Louisiana, United States, 70815 | |
| United States, Maryland | |
| Greenebaum Cancer Center at University of Maryland Medical Center | |
| Baltimore, Maryland, United States, 21201 | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, Massachusetts | |
| UMASS Memorial Cancer Center - University Campus | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| Hurley Medical Center | |
| Flint, Michigan, United States, 48503 | |
| Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | |
| St. Joseph, Michigan, United States, 49085 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0942 | |
| West Michigan Cancer Center | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| United States, Minnesota | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| Mercy and Unity Cancer Center at Mercy Hospital | |
| Coon Rapids, Minnesota, United States, 55433 | |
| Fairview Southdale Hospital | |
| Edina, Minnesota, United States, 55435 | |
| Hubert H. Humphrey Cancer Center at North Memorial Medical Center | |
| Robbinsdale, Minnesota, United States, 55422-2900 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| Fairview Ridges Hospital | |
| Burnsville, Minnesota, United States, 55337 | |
| Mercy and Unity Cancer Center at Unity Hospital | |
| Fridley, Minnesota, United States, 55432 | |
| Park Nicollet Health Services | |
| St. Louis Park, Minnesota, United States, 55416 | |
| Ridgeview Medical Center | |
| Waconia, Minnesota, United States, 55387 | |
| United Hospital | |
| St. Paul, Minnesota, United States, 55102 | |
| Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | |
| Minneapolis, Minnesota, United States, 55407 | |
| United States, Mississippi | |
| Regional Cancer Center at Singing River Hospital | |
| Pascagoula, Mississippi, United States, 39581 | |
| St. Dominic Cancer Center | |
| Jackson, Mississippi, United States, 39216 | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216 | |
| United States, Missouri | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| Hulston Cancer Center at Cox Medical Center South | |
| Springfield, Missouri, United States, 65807 | |
| St. John's Regional Health Center | |
| Springfield, Missouri, United States, 65804 | |
| United States, Nebraska | |
| Methodist Estabrook Cancer Center | |
| Omaha, Nebraska, United States, 68114 | |
| United States, Nevada | |
| Saint Mary's Regional Medical Center | |
| Reno, Nevada, United States, 89503 | |
| Washoe Cancer Services at Washoe Medical Center - Reno | |
| Reno, Nevada, United States, 89502 | |
| Women's Cancer Center - Lake Mead | |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at Cooper - Voorhees | |
| Voorhees, New Jersey, United States, 08043 | |
| Fox Chase Virtua Health Cancer Program at Virtua West Jersey | |
| Voorhees, New Jersey, United States, 08043 | |
| Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | |
| Marlton, New Jersey, United States, 08053 | |
| UMDNJ University Hospital | |
| Newark, New Jersey, United States, 07103 | |
| United States, New Mexico | |
| University of New Mexico Cancer Research and Treatment Center | |
| Albuquerque, New Mexico, United States, 87131-5636 | |
| United States, New York | |
| Don Monti Comprehensive Cancer Center at North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| Good Samaritan Hospital Medical Center | |
| West Islip, New York, United States, 11795 | |
| Long Island Jewish Medical Center | |
| New Hyde Park, New York, United States, 11042 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Mount Sinai Medical Center | |
| New York, New York, United States, 10029 | |
| New York Oncology Hematology, PC at Albany Medical Center | |
| Albany, New York, United States, 12208 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| New York Oncology Hematology, PC at Albany Regional Cancer Care | |
| Albany, New York, United States, 12206 | |
| Queens Cancer Center of Queens Hospital | |
| Jamaica, New York, United States, 11432 | |
| Riverview Cancer Care Medical Associates, PC | |
| Rexford, New York, United States, 12148 | |
| New York Oncology Hematology, PC - Hudson | |
| Hudson, New York, United States, 12534 | |
| SUNY Downstate Medical Center | |
| Brooklyn, New York, United States, 11203 | |
| SUNY Upstate Medical University Hospital | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Blumenthal Cancer Center at Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center | |
| Pinehurst, North Carolina, United States, 28374 | |
| Gynecologic Oncology Network | |
| Greenville, North Carolina, United States, 27834 | |
| Presbyterian Cancer Center at Presbyterian Hospital | |
| Charlotte, North Carolina, United States, 28233-3549 | |
| Leo W. Jenkins Cancer Center at ECU Medical School | |
| Greenville, North Carolina, United States, 27835-6028 | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Piedmont Hematology-Oncology Associates | |
| Winston-Salem, North Carolina, United States, 27103 | |
| Hope A Women's Cancer Center | |
| Asheville, North Carolina, United States, 28801 | |
| United States, Ohio | |
| UVMC Cancer Care Center at Upper Valley Medical Center | |
| Troy, Ohio, United States, 45373-1300 | |
| Aultman Hospital Cancer Center at Aultman Health Foundation | |
| Canton, Ohio, United States, 44710-1799 | |
| Blanchard Valley Medical Associates | |
| Findlay, Ohio, United States, 45840 | |
| Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106 | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45429 | |
| Charles F. Kettering Memorial Hospital | |
| Kettering, Ohio, United States, 45429 | |
| Charles M. Barrett Cancer Center at University Hospital | |
| Cincinnati, Ohio, United States, 45267 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| David L. Rike Cancer Center at Miami Valley Hospital | |
| Dayton, Ohio, United States, 45409 | |
| Good Samaritan Hospital Cancer Treatment Center | |
| Cincinnati, Ohio, United States, 45220 | |
| Good Samaritan Hospital | |
| Dayton, Ohio, United States, 45406 | |
| Grandview Hospital | |
| Dayton, Ohio, United States, 45405 | |
| Hillcrest Cancer Center at Hillcrest Hospital | |
| Mayfield Heights, Ohio, United States, 44124 | |
| McDowell Cancer Center at Akron General Medical Center | |
| Akron, Ohio, United States, 44307 | |
| MetroHealth's Cancer Care Center at MetroHealth Medical Center | |
| Cleveland, Ohio, United States, 44109 | |
| Middletown Regional Hospital | |
| Middletown, Ohio, United States, 45044 | |
| Mount Carmel Health - West Hospital | |
| Columbus, Ohio, United States, 43222 | |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | |
| Xenia, Ohio, United States, 45385 | |
| Samaritan North Cancer Care Center | |
| Dayton, Ohio, United States, 45415 | |
| United States Air Force Medical Center - Wright-Patterson | |
| Wright-Patterson Afb, Ohio, United States, 45433-5529 | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | |
| Columbus, Ohio, United States, 43210-1240 | |
| Veterans Affairs Medical Center - Dayton | |
| Dayton, Ohio, United States, 45428 | |
| United States, Oklahoma | |
| Cancer Care Associates - Midtown Tulsa | |
| Tulsa, Oklahoma, United States, 74104 | |
| Oklahoma University Cancer Institute | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
| Abramson Cancer Center of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| Drexel University College of Medicine - Center City Hahnemann Campus | |
| Philadelphia, Pennsylvania, United States, 19102 | |
| Fox Chase Cancer Center - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19107-5541 | |
| McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | |
| Reading, Pennsylvania, United States, 19612-6052 | |
| Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | |
| Allentown, Pennsylvania, United States, 18105 | |
| Fox Chase Cancer Center CCOP Research Base | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| UPMC Cancer Center at Magee-Womens Hospital | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Rhode Island | |
| Women and Infants Hospital of Rhode Island | |
| Providence, Rhode Island, United States, 02905 | |
| United States, South Carolina | |
| Hollings Cancer Center at Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, South Dakota | |
| Sioux Valley Hospital and University of South Dakota Medical Center | |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| United States, Tennessee | |
| Baptist Centers for Cancer Care | |
| Memphis, Tennessee, United States, 38120 | |
| Baptist Regional Cancer Center at Baptist Hospital of East Tennessee | |
| Knoxville, Tennessee, United States, 37901 | |
| East Tennessee State University Cancer Center at Johnson City Medical Center | |
| Johnson City, Tennessee, United States, 37604 | |
| University of Tennessee College of Medicine | |
| Memphis, Tennessee, United States, 38163 | |
| United States, Texas | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| Harrington Cancer Center | |
| Amarillo, Texas, United States, 79106 | |
| M.D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | |
| Dallas, Texas, United States, 75390 | |
| UMC Southwest Cancer and Research Center | |
| Lubbock, Texas, United States, 79415-3364 | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555-0361 | |
| United States, Utah | |
| American Fork Hospital | |
| American Fork, Utah, United States, 84003 | |
| Cottonwood Hospital Medical Center | |
| Murray, Utah, United States, 84107 | |
| Dixie Regional Medical Center - East Campus | |
| Saint George, Utah, United States, 84770 | |
| Utah Valley Regional Medical Center - Provo | |
| Provo, Utah, United States, 84604 | |
| Logan Regional Hospital | |
| Logan, Utah, United States, 84321 | |
| McKay-Dee Hospital Center | |
| Ogden, Utah, United States, 84403 | |
| Utah Cancer Specialists at UCS Cancer Center | |
| Salt Lake City, Utah, United States, 84106 | |
| Latter Day Saints Hospital | |
| Salt Lake City, Utah, United States, 84103 | |
| United States, Virginia | |
| Bon Secours Cancer Institute at St. Mary's Hospital | |
| Richmond, Virginia, United States, 23226 | |
| Carilion Gynecologic Oncology Associates | |
| Roanoke, Virginia, United States, 24014 | |
| University of Virginia Cancer Center at UV Health System | |
| Charlottesville, Virginia, United States, 22908 | |
| Virginia Commonwealth University Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| Virginia Oncology Associates - Hampton | |
| Hampton, Virginia, United States, 23666 | |
| Virginia Oncology Associates - Lake Wright | |
| Norfolk, Virginia, United States, 23502 | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98104 | |
| MultiCare Regional Cancer Center at Tacoma General Hospital | |
| Tacoma, Washington, United States, 98405 | |
| United States, Wisconsin | |
| Marshfield Clinic - Marshfield Center | |
| Marshfield, Wisconsin, United States, 54449 | |
| Medical College of Wisconsin Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Study Chair: | Bradley J. Monk, MD | Chao Family Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000306463, GOG-0204 |
| Study First Received: | July 8, 2003 |
| Last Updated: | October 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00064077 History of Changes |
| Health Authority: | United States: Federal Government |
|
cervical adenocarcinoma cervical adenosquamous cell carcinoma cervical squamous cell carcinoma recurrent cervical cancer stage IVB cervical cancer |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Vinblastine Urogenital Neoplasms Genital Diseases, Female Uterine Cervical Neoplasms Uterine Cervical Diseases Neoplasms by Site Cisplatin Therapeutic Uses |
Uterine Neoplasms Gemcitabine Mitosis Modulators Genital Neoplasms, Female Uterine Diseases Enzyme Inhibitors Antimitotic Agents Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Vinorelbine Radiation-Sensitizing Agents Paclitaxel Tubulin Modulators |