A Phase III Randomized Trial of Gemcitabine (NSC# 613327) Plus Docetaxel (NSC# 628503) Followed by Doxorubicin (NSC# 123127) v. Observation for Uterus-Limited, High Grade Uterine Leiomyosarcoma
OBJECTIVES:
Primary
- To determine whether overall survival of patients with uterus-limited high-grade
leiomyosarcoma is superior among patients assigned to treatment with adjuvant
gemcitabine hydrochloride plus docetaxel followed by doxorubicin hydrochloride compared
to patients assigned to observation.
Secondary
- To determine whether treatment with adjuvant gemcitabine plus docetaxel followed by
doxorubicin improves recurrence-free survival of patients with uterus-limited
high-grade leiomyosarcoma compared to observation.
- To explore the impact of potential predictors of recurrence or death such as patient
age, institution-reported tumor size, cervix involvement (yes or no), and mitotic rate.
(exploratory)
OUTLINE: This is a multicenter study. Patients are stratified according to country of
treating site. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive adjuvant gemcitabine hydrochloride IV over 70-90 minutes on
days 1 and 8 and docetaxel IV over 30-60 minutes on day 8. Patients also receive
filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.
Treatment repeats every 21 days for up to 4 courses in the absence of disease
progression or unacceptable toxicity. Patients then undergo computed tomography (CT)
and/or magnetic resonance imaging (MRI). Patients with no evidence of disease receive
doxorubicin hydrochloride IV every 21 days for 4 courses in the absence of disease
progression or unacceptable toxicity. Patients also receive filgrastim SC on days 2-8
or pegfilgrastim SC on day 2 or 3.
- Arm II: Patients undergo observation. After completion of study treatment, patients in
both arms are followed up every 4 months for 3 years and then every 6 months for 2
years.
Interventional
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival
ongoing
No
Martee L. Hensley, MD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: National Cancer Institute
GOG-0277
NCT01533207
July 2012
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
MBCCOP - Hawaii | Honolulu, Hawaii 96813 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain, Connecticut 06050 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center | Milwaukee, Wisconsin 53201-2901 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
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 |
Lake/University Ireland Cancer Center | Mentor, Ohio 44060 |
Women and Infants Hospital of Rhode Island | Providence, Rhode Island 02905 |
Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando, Florida 32803-1273 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Stony Brook University Cancer Center | Stony Brook, New York 11794-8174 |
Batte Cancer Center at Northeast Medical Center | Concord, North Carolina 28025 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Gundersen Lutheran Center for Cancer and Blood | La Crosse, Wisconsin 54601 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
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 |
Cancer Care Associates - Saint Francis Campus | Tulsa, Oklahoma 74136-1929 |
Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa 50266 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
McFarland Clinic, PC | Ames, Iowa 50010 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Cancer Center of Kansas, PA - Liberal | Liberal, Kansas 67905 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
St. James Healthcare Cancer Care | Butte, Montana 59701 |
Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
Sletten Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
Kalispell Medical Oncology at KRMC | Kalispell, Montana 59901 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus, Ohio 43210-1240 |
Vince Lombardi Cancer Clinic - Sheboygan | Sheboygan, Wisconsin 53081 |
Rocky Mountain Oncology | Casper, Wyoming 82609 |
Mid Dakota Clinic, PC | Bismarck, North Dakota 58501 |
Queen's Cancer Institute at Queen's Medical Center | Honolulu, Hawaii 96813 |
Gynecologic Oncology | Hinsdale, Illinois 60521 |
Women's Cancer Center - La Canada | Las Vegas, Nevada 89169 |
St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
Kapiolani Medical Center for Women and Children | Honolulu, Hawaii 96826 |
Medcenter One Hospital Cancer Care Center | Bismarck, North Dakota 58501 |
St. Alexius Medical Center Cancer Center | Bismarck, North Dakota 58502 |
Aurora Women's Pavilion of West Allis Memorial Hospital | West Allis, Wisconsin 53227 |
Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh, Wisconsin 54904 |
Cancer Center of Kansas, PA - McPherson | McPherson, Kansas 67460 |
St. Vincent Oncology Center | Indianapolis, Indiana 46260 |
Mercy Clinic Cancer and Hematology - Rolla | Rolla, Missouri 65401 |
Mercy Cancer Center - West Lakes | Clive, Iowa 50325 |
Methodist West Hospital | West Des Moines, Iowa 50266-7700 |