Paclitaxel and Carboplatin in Treating Patients With Persistent or Recurrent Stage III or Stage IV Uterine Cancer
- Registration Number
- NCT00112489
- Lead Sponsor
- Gynecologic Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin works in treating patients with persistent or recurrent stage III or stage IV uterine cancer.
- Detailed Description
OBJECTIVES:
* Determine the antitumor activity of paclitaxel and carboplatin in patients with persistent or recurrent stage III or IV uterine carcinosarcoma.
* Determine the nature and degree of toxicity of this regimen in these patients.
OUTLINE: This is a non-randomized, multicenter study.
Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: Approximately 14-47 patients will be accrued for this study within 20 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 55
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Taxol-Carbo carboplatin Paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC = 6 IV over 30 minutes every 21 days until disease progression or adverse effects prohibit further therapy Taxol-Carbo paclitaxel Paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC = 6 IV over 30 minutes every 21 days until disease progression or adverse effects prohibit further therapy
- Primary Outcome Measures
Name Time Method Nature and Degree of Toxicity During study treatment and up to 30 days after stopping study treatment Number of patients who experienced grade 1 or higher serious adverse event (term or group) regardless of attribution using CTCAE v3.0
Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.0 Best Response Response was measured every other cycle (q 6 weeks) until disease progression is documented. Primary outcome measured according to RECIST v1.0 Best Response:
Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.
Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (110)
Fox Chase Cancer Center CCOP Research Base
🇺🇸Philadelphia, Pennsylvania, United States
Mount Carmel Health - West Hospital
🇺🇸Columbus, Ohio, United States
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
St. Vincent Indianapolis Hospital
🇺🇸Indianapolis, Indiana, United States
St. Vincent's Medical Center
🇺🇸Jacksonville, Florida, United States
Tunnell Cancer Center at Beebe Medical Center
🇺🇸Lewes, Delaware, United States
Holland Community Hospital
🇺🇸Holland, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
🇺🇸Dearborn, Michigan, United States
Metro Health Hospital
🇺🇸Grand Rapids, Michigan, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
Union Hospital Cancer Program at Union Hospital
🇺🇸Elkton, Maryland, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
🇺🇸New Britain, Connecticut, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
MBCCOP - Medical College of Georgia Cancer Center
🇺🇸Augusta, Georgia, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
Battle Creek Health System Cancer Care Center
🇺🇸Battle Creek, Michigan, United States
University of Illinois Cancer Center
🇺🇸Chicago, Illinois, United States
Seton Cancer Institute at Saint Mary's - Saginaw
🇺🇸Saginaw, Michigan, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
Mercy Regional Cancer Center at Mercy Hospital
🇺🇸Port Huron, Michigan, United States
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis
🇺🇸Saint Louis, Missouri, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
University of Mississippi Cancer Clinic
🇺🇸Jackson, Mississippi, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
Kinki University School of Medicine
🇯🇵Osaka, Osaka, Japan
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
University Cancer Center at University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Shikoku Cancer Center
🇯🇵Matsuyama, Japan
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Jersey Shore Cancer Center at Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Kagoshima City Hospital
🇯🇵Kagoshima City, Kagoshima, Japan
Hackley Hospital
🇺🇸Muskegon, Michigan, United States
Saint Mary's Health Center
🇺🇸Saint Louis, Missouri, United States
Iwate Medical University Hospital
🇯🇵Morioka, Iwate, Japan
Presbyterian Cancer Center at Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Hillcrest Cancer Center at Hillcrest Hospital
🇺🇸Mayfield Heights, Ohio, United States
Lake/University Ireland Cancer Center
🇺🇸Mentor, Ohio, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Cleveland Clinic Cancer Center at Fairview Hospital
🇺🇸Cleveland, Ohio, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Kobe Medical Center
🇯🇵Kobe, Japan
Tottori University Hospital
🇯🇵Tottori, Japan
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
🇺🇸Birmingham, Alabama, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
National Kyushu Cancer Center
🇯🇵Minami-ku, Japan
National Hospital Organization - Medical Center of Kure
🇯🇵Kure, Japan
Tohoku University Graduate School of Medicine
🇯🇵Sendai, Japan
Keio University School of Medicine
🇯🇵Shinjuku-ku, Japan
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
Mecosta County Medical Center
🇺🇸Big Rapids, Michigan, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
Butterworth Hospital at Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸Los Angeles, California, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Lacks Cancer Center at Saint Mary's Health Care
🇺🇸Grand Rapids, Michigan, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
Hope A Women's Cancer Center
🇺🇸Asheville, North Carolina, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
🇺🇸Allentown, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Black Hills Obstetrics & Gynecology LLP
🇺🇸Rapid City, South Dakota, United States
Hall and Martin, M.Ds., PC
🇺🇸Knoxville, Tennessee, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Carilion Gynecologic Oncology Associates
🇺🇸Roanoke, Virginia, United States
Hinsdale Hematology Oncology Associates
🇺🇸Hinsdale, Illinois, United States
Cancer Institute of New Jersey at Cooper - Voorhees
🇺🇸Voorhees, New Jersey, United States
Cancer Care Associates - Midtown Tulsa
🇺🇸Tulsa, Oklahoma, United States
Oklahoma University Cancer Institute
🇺🇸Oklahoma City, Oklahoma, United States
Woman's Hospital
🇺🇸Baton Rouge, Louisiana, United States
St. Mary Mercy Hospital
🇺🇸Livonia, Michigan, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
St. Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Foote Memorial Hospital
🇺🇸Jackson, Michigan, United States
Harrington Cancer Center
🇺🇸Amarillo, Texas, United States
Parkland Memorial Hospital
🇺🇸Dallas, Texas, United States
Hokkaido University Hospital
🇯🇵Sapporo, Japan
Women and Infants Hospital of Rhode Island
🇺🇸Providence, Rhode Island, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Fletcher Allen Health Care - University Health Center Campus
🇺🇸Burlington, Vermont, United States
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States
James Graham Brown Cancer Center at University of Louisville
🇺🇸Louisville, Kentucky, United States
Saint Joseph Mercy Cancer Center
🇺🇸Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
Piedmont Hematology-Oncology Associates
🇺🇸Winston-Salem, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Methodist Estabrook Cancer Center
🇺🇸Omaha, Nebraska, United States
Medical College of Wisconsin Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Froedtert Hospital and Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Lucille P. Markey Cancer Center at University of Kentucky
🇺🇸Lexington, Kentucky, United States
Virginia Commonwealth University Massey Cancer Center
🇺🇸Richmond, Virginia, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States