A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12 Monthly Cycles of Single Agent Paclitaxel or Xyotax (CT-2103) (IND# 70177), Versus No Treatment Until Documented Relapse in Women With Advanced Ovarian or Primary Peritoneal or Fallopian Tube Cancer Who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy
OBJECTIVES:
Primary
- Compare overall survival of patients with stage III or IV ovarian epithelial or primary
peritoneal cancer or fallopian tube cancer in clinical complete response after prior
primary platinum and taxane-based chemotherapy treated with paclitaxel vs polyglutamate
paclitaxel as consolidation/maintenance therapy vs no further anticancer therapy until
documented disease progression.
Secondary
- Compare progression-free survival of patients treated with these drugs.
- Compare the toxicity profile of these drugs, particularly peripheral neuropathy, in
these patients.
- Compare the quality of life of patients treated with these drugs.
Tertiary
- Correlate angiogenic marker expression with overall or progression-free survival of
patients treated with these drugs.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease stage at diagnosis (stage III vs stage IV); presence of macroscopic disease after
initial debulking surgery (yes vs no); type of prior taxane-based therapy (docetaxel vs
paclitaxel); and route of prior platinum therapy (intraperitoneal vs IV). Patients are
randomized to 1 of 3 treatment arms.
- Arm I: Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.
- Arm II: Patients receive paclitaxel IV over 3 hours on day 1.
- Arm III: Patients receive no further anticancer treatment until evidence of disease
progression.
In arms I and II, treatment repeats every 28 days for up to 12 courses in the absence of
disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, before courses 3, 5, and 7 of study treatment, at
completion of study treatment, and then at 1 year after completion of study treatment.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 1,110 patients (555 per treatment arm) will be accrued for
this study within 8.5 years.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Overall survival
No
Larry J. Copeland, MD
Study Chair
Ohio State University Comprehensive Cancer Center
United States: Food and Drug Administration
GOG-0212
NCT00108745
March 2005
Name | Location |
---|---|
Louisiana State University | New Orleans, Louisiana 70112-2282 |
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Mayo Clinic | Rochester, Minnesota 55905 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Tacoma General Hospital | Tacoma, Washington 98405 |
Pennsylvania Hospital | Philadelphia, Pennsylvania 19107 |
Boulder Community Hospital | Boulder, Colorado 80301-9019 |
Porter Adventist Hospital | Denver, Colorado 80210 |
Rose Medical Center | Denver, Colorado 80220 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
Morristown Memorial Hospital | Morristown, New Jersey 07962-1956 |
Henry Ford Hospital | Detroit, Michigan 48202 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
Akron General Medical Center | Akron, Ohio 44302 |
Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
LDS Hospital | Salt Lake City, Utah 84143 |
Waukesha Memorial Hospital | Waukesha, Wisconsin 53188 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Cedars-Sinai Medical Center | Los Angeles, California 90048 |
North Shore University Hospital | Manhasset, New York 11030 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
Hartford Hospital | Hartford, Connecticut 06102-5037 |
Sarasota Memorial Hospital | Sarasota, Florida 34239 |
Franklin Square Hospital Center | Baltimore, Maryland 21237 |
Baystate Medical Center | Springfield, Massachusetts 01199 |
William Beaumont Hospital | Royal Oak, Michigan 48073 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
New Hanover Regional Medical Center | Wilmington, North Carolina 28402-9025 |
University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
Winthrop University Hospital | Mineola, New York 11501 |
MetroHealth Medical Center | Cleveland, Ohio 44109 |
Central Baptist Hospital | Lexington, Kentucky 40503 |
Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
Mount Sinai Medical Center | New York, New York 10029 |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
Sibley Memorial Hospital | Washington, District of Columbia 20016 |
North Colorado Medical Center | Greeley, Colorado 80631 |
Cancer Center of Kansas - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas - Dodge City | Dodge City, Kansas 67801 |
Cancer Center of Kansas - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas - Salina | Salina, Kansas 67042 |
Cancer Center of Kansas - Wellington | Wellington, Kansas 67152 |
Associates in Womens Health | Wichita, Kansas 67203 |
Cancer Center of Kansas - Winfield | Winfield, Kansas 67156 |
Munson Medical Center | Traverse City, Michigan 49684 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Gynecologic Oncology of Indiana | Indianapolis, Indiana 46237 |
South Bend Clinic | South Bend, Indiana 46617 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio 43210-1240 |
Beebe Medical Center | Lewes, Delaware 19958 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Exempla Lutheran Medical Center | Wheat Ridge, Colorado 80033 |
Mercy Hospital | Coon Rapids, Minnesota 55433 |
Medical Oncology and Hematology Associates | Des Moines, Iowa 50309 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Fairview-Southdale Hospital | Edina, Minnesota 55435 |
Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Regions Hospital | Saint Paul, Minnesota 55101 |
Geisinger Medical Group | State College, Pennsylvania 16801 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Miami Valley Hospital | Dayton, Ohio 45409 |
Eastern Connecticut Hematology and Oncology Associates | Norwich, Connecticut 06360 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Research Medical Center | Kansas City, Missouri 64132 |
Saint Luke's East - Lee's Summit | Lee's Summit, Missouri 64086 |
Woman's Hospital | Baton Rouge, Louisiana 70815 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
Morton Plant Hospital | Clearwater, Florida 33756 |
Singing River Hospital | Pascagoula, Mississippi 39581 |
Methodist Hospital | Houston, Texas 77030 |
Greater Baltimore Medical Center | Baltimore, Maryland 21204 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
AnMed Health Cancer Center | Anderson, South Carolina 29621 |
Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Mayo Clinic in Arizona | Scottsdale, Arizona 85259-5404 |
Mayo Clinic in Florida | Jacksonville, Florida 32224 |
Pacific Gynecology Specialists | Seattle, Washington 98104 |
Washington Hospital Center | Washington, District of Columbia 20010 |
Memorial Medical Center | Springfield, Illinois 62781 |
Metro Health Hospital | Grand Rapids, Michigan 49506 |
University of Virginia | Charlottesville, Virginia 22908 |
University of Pittsburgh | Pittsburgh, Pennsylvania 15261 |
New York Hospital Medical Center of Queens | Fresh Meadows, New York 11365 |
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
Vanderbilt University | Nashville, Tennessee 37232-6305 |
University of North Carolina | Chapel Hill, North Carolina 27599 |
Duke University Medical Center | Durham, North Carolina 27710 |
Northwestern University | Chicago, Illinois 60611 |
Queens Hospital Center | Jamaica, New York 11432 |
Saint Louis University Hospital | St. Louis, Missouri 63110-0250 |
University of Connecticut | Farmington, Connecticut 06032 |
Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
University of California at San Diego | La Jolla, California 92093 |
Case Western Reserve University | Cleveland, Ohio 44106 |
Yale University | New Haven, Connecticut 06520 |
Wayne State University | Detroit, Michigan 48202 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
Indiana University Medical Center | Indianapolis, Indiana 46202 |
University of Texas Southwestern Medical Center | Dallas, Texas |
University of Kentucky | Lexington, Kentucky 40536-0098 |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Northwest Hospital | Seattle, Washington 98133 |
Virginia Mason CCOP | Seattle, Washington 98101 |
Metro-Minnesota CCOP | St. Louis Park, Minnesota |
UC Davis Comprehensive Cancer Center | Sacramento, California 95817 |
Tufts Medical Center | Boston, Massachusetts 02111 |
Oregon Health and Science University | Portland, Oregon 97201 |
Florida Gynecologic Oncology | Fort Myers, Florida 33901 |
Jersey Shore Medical Center | Neptune, New Jersey 07754 |
Decatur Memorial Hospital | Decatur, Illinois 62526 |
Westchester County Medical Center | Valhalla, New York 10595 |
Tulane University Health Sciences Center | New Orleans, Louisiana 70112 |
Virginia Commonwealth University | Richmond, Virginia |
Central Georgia Gynecologic Oncology | Macon, Georgia 31201 |
Providence Saint Joseph Medical Center | Burbank, California 91505-4866 |
Florida Hospital | Orlando, Florida 32803 |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
Hillcrest Hospital Cancer Center | Mayfield Heights, Ohio 44124 |
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
M D Anderson Cancer Center | Houston, Texas 77030 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
Chattanooga's Program in Women's Oncology | Chattanooga, Tennessee 37403 |
Northern Virginia Pelvic Surgery Associates | Annandale, Virginia 22003 |
Virginia Oncology Associates - Lake Wright | Norfolk, Virginia 23502 |
University of Cincinnati | Cincinnati, Ohio 45267-0502 |
Penn State Milton S Hershey Medical Center | Hershey, Pennsylvania 17033 |
The Community Hospital | Munster, Indiana 46321 |
Littleton Adventist Hospital | Littleton, Colorado 80122 |
Parker Adventist Hospital | Parker, Colorado 80138 |
Froedtert and the Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
Sutter General Hospital | Sacramento, California 95816 |
University of California San Francisco Medical Center-Mount Zion | San Francisco, California 94115 |
Penrose-Saint Francis Healthcare | Colorado Springs, Colorado 80907 |
Exempla Saint Joseph Hospital | Denver, Colorado 80218 |
Colorado Cancer Research Program CCOP | Denver, Colorado 80224-2522 |
Saint Mary's Hospital and Regional Medical Center | Grand Junction, Colorado 81502 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
The Hospital of Central Connecticut | New Britain, Connecticut 06050 |
M D Anderson Cancer Center- Orlando | Orlando, Florida 32806 |
John B Amos Cancer Center | Columbus, Georgia 31904 |
Iowa Oncology Research Association CCOP | Des Moines, Iowa 50309 |
Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates-Des Moines | Des Moines, Iowa 50309 |
Cancer Center of Kansas - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas-Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas - Main Office | Wichita, Kansas 67214 |
Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Spectrum Health at Butterworth Campus | Grand Rapids, Michigan 49503 |
Mercy Health Partners-Mercy Campus | Muskegon, Michigan 49443 |
Lakeland Hospital | St. Joseph, Michigan 49085 |
Saint Luke's Hospital of Duluth | Duluth, Minnesota 55805 |
Unity Hospital | Fridley, Minnesota 55432 |
Minnesota Oncology Hematology PA-Maplewood | Maplewood, Minnesota 55109 |
North Memorial Medical Health Center | Robbinsdale, Minnesota 55422 |
Park Nicollet Clinic - Saint Louis Park | Saint Louis Park, Minnesota 55416 |
Minnesota Oncology and Hematology PA-Woodbury | Woodbury, Minnesota 55125 |
Saint John's Regional Medical Center | Joplin, Missouri 64804 |
Freeman Health System | Joplin, Missouri 64804 |
Saint Luke's Cancer Institute | Kansas City, Missouri 64111 |
Saint Luke's Hospital of Kansas City | Kansas City, Missouri 64111 |
Saint John's Mercy Medical Center | Saint Louis, Missouri 63141 |
Saint John's Hospital | Springfield, Missouri 65804 |
Cox Medical Center | Springfield, Missouri 65807 |
Cooper Hospital University Medical Center | Camden, New Jersey 08103 |
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County | Mount Holly, New Jersey 08060 |
Memorial Medical Center - Las Cruces | Las Cruces, New Mexico 88011 |
New York University Langone Medical Center | New York, New York 10016 |
Columbia University Medical Center | New York, New York 10032 |
State University of New York Upstate Medical University | Syracuse, New York 13210 |
Alamance Regional Medical Center | Burlington, North Carolina 27216 |
Aultman Health Foundation | Canton, Ohio 44710 |
Kettering Medical Center | Kettering, Ohio 45429 |
Northwest Cancer Specialists-Rose Quarter Cancer Center | Portland, Oregon 97227 |
Saint Luke's Hospital | Bethlehem, Pennsylvania 18015 |
Geisinger Wyoming Valley | Wilkes-Barre, Pennsylvania 18711 |
Upstate Carolina CCOP | Spartanburg, South Carolina 29303 |
The Don and Sybil Harrington Cancer Center | Amarillo, Texas 79106 |
Harrison Bremerton Hematology and Oncology | Bremerton, Washington 98310 |
Swedish Medical Center-First Hill | Seattle, Washington 98122-4307 |
Saint Vincent Hospital | Green Bay, Wisconsin 54301 |
Green Bay Oncology Limited at Saint Mary's Hospital | Green Bay, Wisconsin 54303 |
Green Bay Oncology at Saint Vincent Hospital | Green Bay, Wisconsin 54301-3526 |
Bay Area Medical Center | Marinette, Wisconsin 54143 |
University of California Medical Center At Irvine-Orange Campus | Orange, California 92868 |
Cancer Care Associates-Yale | Tulsa, Oklahoma 74136-1929 |
Women and Infants Hospital | Providence, Rhode Island 02905 |
University of Maryland Greenebaum Cancer Center | Baltimore, Maryland 21201 |
Lake University Ireland Cancer Center | Mentor, Ohio 44060 |
Lyndon Baines Johnson General Hospital | Houston, Texas 77030 |
Women's Cancer Associates | Saint Petersburg, Florida 33701 |
University of Illinois | Chicago, Illinois 60612 |
Stony Brook University Medical Center | Stony Brook, New York 11794 |
University of Colorado Cancer Center - Anschutz Cancer Pavilion | Aurora, Colorado 80045 |
Michiana Hematology Oncology PC-Elkhart | Elkhart, Indiana 46514 |
Michiana Hematology Oncology PC-Plymouth | Plymouth, Indiana 46563 |
Michiana Hematology Oncology PC-South Bend | South Bend, Indiana 46601 |
Michiana Hematology Oncology-PC Westville | Westville, Indiana 46391 |
University of Michigan University Hospital | Ann Arbor, Michigan 48109 |
Michiana Hematology Oncology PC-Niles | Niles, Michigan 49120 |
University of Missouri - Ellis Fischel | Columbia, Missouri 65203 |
Moses Cone Health System-Regional Cancer Center | Greensboro, North Carolina 27403 |
Holy Family Memorial Hospital | Manitowoc, Wisconsin 54221 |
Vince Lombardi Cancer Clinic-Sheboygan | Sheboygan, Wisconsin 53081 |
Vince Lombardi Cancer Clinic - Slinger | Slinger, Wisconsin 53086 |
Advocate Lutheran General Hospital | Park Ridge, Illinois 60068 |
Gynecologic Oncology of West Michigan PLLC | Grand Rapids, Michigan 49546 |
Center of Hope at Renown Medical Center | Reno, Nevada 89502 |
State University of New York Downstate Medical Center | Brooklyn, New York 11203 |
Monter Cancer Center | Lake Success, New York 11042 |
Hope, A Women's Cancer Center | Asheville, North Carolina 28816 |
Magee-Womens Hospital - University of Pittsburgh Medical Center | Pittsburgh, Pennsylvania 15213 |
Black Hills Obstetrics and Gynecology | Rapid City, South Dakota 57701 |
Chattanooga Gynecological Oncology | Chattanooga, Tennessee 37403 |
Carilion Clinic Gynecological Oncology | Roanoke, Virginia 24016 |
Aurora Women's Pavilion of Aurora West Allis Medical Center | West Allis, Wisconsin 53227 |
Long Beach Memorial Medical Center-Todd Cancer Institute | Long Beach, California 90806 |
Kaiser Permanente Los Angeles Medical Center | Los Angeles, California 90027 |
Rocky Mountain Gynecologic Oncology PC | Englewood, Colorado 80110 |
Norton Health Care Pavilion - Downtown | Louisville, Kentucky 40202 |
Christus Schumpert Saint Mary's Place | Shreveport, Louisiana 71101 |
University of Minnesota Medical Center-Fairview | Minneapolis, Minnesota 55455 |
Saint Dominic-Jackson Memorial Hospital | Jackson, Mississippi 39216 |
Southwest Gynecologic Oncology Associates Inc | Albuquerque, New Mexico 87106 |
Knoxville Gynecologic Cancer Specialists PC | Knoxville, Tennessee 37920 |
Women's Cancer Center of Nevada | Las Vegas, Nevada 89109 |
Central DuPage Hospital Cancer Center | Warrenville, Illinois 60555 |
Saint Luke's South Hospital | Overland Park, Kansas 66213 |
Kansas City CCOP | Prairie Village, Kansas 66208 |
Spectrum Health Reed City Hospital | Reed City, Michigan 49677 |
Gundersen Lutheran | La Crosse, Wisconsin 54601 |
Walter Reed National Military Medical Center | Bethesda, Maryland 20889 |
Palo Alto Medical Foundation-Gynecologic Oncology | Mountain View, California 94040 |
Sudarshan K Sharma MD Limted-Gynecologic Oncology | Hinsdale, Illinois 60521 |
University of Massachusetts Memorial Health Care | Worcester, Massachusetts 01605 |
University Medical Center Brackenridge | Austin, Texas 78701 |
Skagit Valley Hospital Regional Cancer Care Center | Mount Vernon, Washington 98274 |
Providence Saint Mary Regional Cancer Center | Walla Walla, Washington 99362 |
Aurora Saint Luke's Medical Center | Milwaukee, Wisconsin 53215 |
Jonsson Comprehensive Cancer Center | Los Angeles, California 90095 |
Carle Foundation - Carle Cancer Center | Urbana, Illinois 61801 |
Michiana Hematology Oncology PC-Mishawaka | Mishawaka, Indiana 46545-1470 |
Summa Akron City Hospital | Akron, Ohio 44304 |
Sanford USD Medical Center - Sioux Falls | Sioux Falls, South Dakota 57117-5134 |
Geisinger Medical Center-Cancer Center Hazelton | Hazleton, Pennsylvania 18201 |
Community Howard Regional Health | Kokomo, Indiana 46904 |
Indiana University Health La Porte Hospital | La Porte, Indiana 46350 |
Saint Joseph Regional Medical Center-Mishawaka | Mishawaka, Indiana 46545-1470 |
Christiana Care Health System-Christiana Hospital | Newark, Delaware 19718 |
Bronson Battle Creek | Battle Creek, Michigan 49017 |
Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland, Ohio 44111 |
Saint Joseph's Hospital and Medical Center | Phoenix, Arizona 85013 |
Kaiser Permanente Medical Care Program - Los Angeles Medical Center & Sunset Hospital | Los Angeles, California 90027 |
Southeast Gynecologic Oncology Associates | Jacksonville, Florida 32204 |
The James Graham Brown Cancer Center at University of Louisville | Louisville, Kentucky 40202 |
Women's Cancer Care Associates LLC | Albany, New York 12208 |
Island Gynecologic Oncology | Brightwaters, New York 11718 |
Fletcher Allen Health Care-Medical Center | Burlington, Vermont 05401 |
Aurora Cancer Care-Grafton | Grafton, Wisconsin 53024 |