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
OBJECTIVES:
- Compare the survival and response of patients with stage IVB, recurrent, or persistent
carcinoma of the cervix when treated with paclitaxel and cisplatin vs vinorelbine and
cisplatin vs gemcitabine and cisplatin vs topotecan and cisplatin.
- Compare the toxic effects of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 4
treatment arms.
- Arm I: Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 1-4
hours on day 2.
- Arm II: Patients receive vinorelbine IV over 6-10 minutes on days 1 and 8 and cisplatin
IV over 1-4 hours on day 1.
- Arm III: Patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and
cisplatin as in arm II.
- Arm IV: Patients receive topotecan IV over 30 minutes on days 1-3 and cisplatin as in
arm II.
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Quality of life as measured by the FACT-Cervical Trial Outcome of Index and the FACT-Gynecologic Oncology Group/Neurotoxicity subscale at baseline, courses 2 and 5, and 9 months after completion of study treatment
Yes
Bradley J. Monk, MD
Study Chair
Chao Family Comprehensive Cancer Center
United States: Federal Government
CDR0000306463
NCT00064077
July 2003
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain, Connecticut 06050 |
Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
Drexel University College of Medicine - Center City Hahnemann Campus | Philadelphia, Pennsylvania 19102 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
Northwest Community Hospital | Arlington Heights, Illinois 60005 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
CCOP - Dayton | Kettering, Ohio 45429 |
Harrington Cancer Center | Amarillo, Texas 79106 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
University of Miami Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
UMASS Memorial Cancer Center - University Campus | Worcester, Massachusetts 01605-2982 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Gynecologic Oncology Network | Greenville, North Carolina 27858 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
MetroHealth's Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44106 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
UPMC Cancer Center at Magee-Womens Hospital | Pittsburgh, Pennsylvania 15213-3180 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
MultiCare Regional Cancer Center at Tacoma General Hospital | Tacoma, Washington 98405 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
University of California Davis Cancer Center | Sacramento, California 95817 |
University of New Mexico Cancer Research and Treatment Center | Albuquerque, New Mexico 87131 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
Queens Cancer Center of Queens Hospital | Jamaica, New York 11432 |
James Graham Brown Cancer Center at University of Louisville | Louisville, Kentucky 40202 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
UMDNJ University Hospital | Newark, New Jersey 07103 |
SUNY Downstate Medical Center | Brooklyn, New York 11203 |
McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
Cancer Care Associates - Midtown Tulsa | Tulsa, Oklahoma 74104 |
Women and Infants Hospital of Rhode Island | Providence, Rhode Island 02905 |
Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
University of Tennessee College of Medicine | Memphis, Tennessee 38103 |
M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |
Carilion Gynecologic Oncology Associates | Roanoke, Virginia 24014 |
Latter Day Saints Hospital | Salt Lake City, Utah 84143 |
Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
Yale Cancer Center | New Haven, Connecticut 06520-8028 |
Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando, Florida 32803-1273 |
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
Mount Sinai Medical Center | New York, New York 10029 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
Aultman Hospital Cancer Center at Aultman Health Foundation | Canton, Ohio 44710-1799 |
Torrance Memorial Medical Center | Torrance, California 90505 |
American Fork Hospital | American Fork, Utah 84003 |
Logan Regional Hospital | Logan, Utah 84321 |
Cottonwood Hospital Medical Center | Murray, Utah 84107 |
McKay-Dee Hospital Center | Ogden, Utah 84403 |
Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah 84106 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | Saint Joseph, Michigan 49085 |
Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
M.D. Anderson Cancer Center at Orlando | Orlando, Florida 32806 |
Don Monti Comprehensive Cancer Center at North Shore University Hospital | Manhasset, New York 11030 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
East Tennessee State University Cancer Center at Johnson City Medical Center | Johnson City, Tennessee 37604 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange, California 92868 |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
Cancer Center of Santa Barbara | Santa Barbara, California 93105 |
Todd Cancer Institute at Long Beach Memorial Medical Center | Long Beach, California 90801 |
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Women's Cancer Center - Lake Mead | Las Vegas, Nevada 89102 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees, New Jersey 08043 |
Hope A Women's Cancer Center | Asheville, North Carolina 28801 |
Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights, Ohio 44124 |
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown, Pennsylvania 18105 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
Baptist Centers for Cancer Care | Memphis, Tennessee 38120 |
Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter, Florida 33458 |
Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey, Illinois 60426 |
St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
Howard Community Hospital at Howard Regional Health System | Kokomo, Indiana 46904 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
Reid Hospital & Health Care Services, Incorporated | Richmond, Indiana 47374 |
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Hubert H. Humphrey Cancer Center at North Memorial Medical Center | Robbinsdale, Minnesota 55422-2900 |
Park Nicollet Health Services | St. Louis Park, Minnesota 55416 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
Grandview Hospital | Dayton, Ohio 45405 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee | Knoxville, Tennessee 37901 |
UMC Southwest Cancer and Research Center | Lubbock, Texas 79415-3364 |
Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
Virginia Oncology Associates - Hampton | Hampton, Virginia 23666 |
Regional Cancer Center at Singing River Hospital | Pascagoula, Mississippi 39581 |
Washoe Cancer Services at Washoe Medical Center - Reno | Reno, Nevada 89502 |
Leo W. Jenkins Cancer Center at ECU Medical School | Greenville, North Carolina 27834 |
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
Highlands Oncology Group - Fayetteville | Fayetteville, Arkansas 72703 |
Washington Regional Medical Center | Fayetteville, Arkansas 72703 |
Colorado Gynecologic Oncology Group P.C. | Aurora, Colorado 80010 |
Woman's Hospital | Baton Rouge, Louisiana 70815 |
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center | Pinehurst, North Carolina 28374 |
Fox Chase Cancer Center CCOP Research Base | Philadelphia, Pennsylvania 19140 |
Bon Secours Cancer Institute at St. Mary's Hospital | Richmond, Virginia 23226 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
Sansum Medical Clinic | Santa Barbara, California 93105 |
University of Virginia Cancer Center at UV Health System | Charlottesville, Virginia 22908 |
Santa Barbara Hematology Oncology Medical Group at Cancer Center of Santa Barbara | Santa Barbara, California 93105 |
Stanford Comprehensive Cancer Center - Stanford | Stanford, California 94305 |
Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham | Birmingham, Alabama 35294 |
Louisville Oncology at Norton Cancer Center | Louisville, Kentucky 40202 |
Good Samaritan Hospital Cancer Treatment Center | Cincinnati, Ohio 45220 |
United States Air Force Medical Center - Wright-Patterson | Wright-Patterson AFB, Ohio 45433-5529 |
Esther Marie Hatton Cancer Care Center at St. Elizabeth Medical Center | Edgewood, Kentucky 41017 |
Piedmont Hematology-Oncology Associates | Winston-Salem, North Carolina 27103 |
Saint Mary's Regional Medical Center | Reno, Nevada 89503 |
New York Oncology Hematology, PC at Albany Regional Cancer Care | Albany, New York 12208 |
Riverview Cancer Care Medical Associates, PC | Rexford, New York 12148 |
Good Samaritan Hospital Medical Center | West Islip, New York 11795 |
St. Dominic Cancer Center | Jackson, Mississippi 39216 |
Chicago Gynecologic Oncology | Palatine, Illinois 60067 |
New York Oncology Hematology, PC at Albany Medical Center | Albany, New York 12208 |
New York Oncology Hematology, PC - Hudson | Hudson, New York 12534 |
Virginia Oncology Associates - Lake Wright | Norfolk, Virginia 23502 |