Topotecan in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
- Conditions
- Ovarian CancerFallopian Tube CancerPrimary Peritoneal Cavity Cancer
- Interventions
- Registration Number
- NCT00114166
- Lead Sponsor
- Gynecologic Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving topotecan in different dosing schedules may kill more tumor cells.
PURPOSE: This phase II trial is studying how well topotecan works in treating patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.
- Detailed Description
OBJECTIVES:
Primary
* Determine the antitumor activity of topotecan, in terms of frequency and duration of tumor response, in patients with recurrent platinum-sensitive ovarian epithelial, fallopian tube, or primary peritoneal cancer.
* Determine the nature and degree of toxicity of this regimen in these patients.
Secondary
* Determine the duration of progression-free survival and overall survival in patients treated with these regimens.
* Determine the effects of prognostic variables (i.e., initial performance status, age, and mucinous or clear cell histology) in patients treated with these regimens.
OUTLINE: This is a multicenter study.
Patients receive topotecan IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 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 38-110 patients (19-55 per treatment arm) will be accrued for this study within 15-30 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 81
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Topotecan 1.25 mg/m2 IV days 1-5 of a 21 day cycle topotecan hydrochloride Topotecan 1.25 mg/m2 IV days 1-5 of a 21 day cycle until disease progression or adverse effects prohibit further therapy Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28 day cycle topotecan hydrochloride Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28 day cycle until disease progression or adverse effects prohibit further therapy
- Primary Outcome Measures
Name Time Method Objective Tumor Response Every other cycle for the first 6 months, then every 3 months x2, then every 6 months until disease progression or study withdrawal Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0):
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.
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.
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.
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.Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0 Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
- Secondary Outcome Measures
Name Time Method Reason Off Study Therapy study entry through end of study treatment, up to 5 years
Trial Locations
- Locations (78)
Fox Chase Cancer Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Tufts-NEMC Cancer Center
🇺🇸Boston, Massachusetts, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
University of Illinois Cancer Center
🇺🇸Chicago, Illinois, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
UMASS Memorial Cancer Center - University Campus
🇺🇸Worcester, Massachusetts, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Bryn Mawr Hospital
🇺🇸Bryn Mawr, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
William Beaumont Hospital - Royal Oak Campus
🇺🇸Royal Oak, Michigan, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
🇺🇸New Britain, Connecticut, United States
Tunnell Cancer Center at Beebe Medical Center
🇺🇸Lewes, Delaware, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Washington Cancer Institute at Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
MBCCOP - Medical College of Georgia Cancer Center
🇺🇸Augusta, Georgia, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
Hinsdale Hematology Oncology Associates
🇺🇸Hinsdale, Illinois, United States
Advocate Lutheran General Cancer Care Center
🇺🇸Park Ridge, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Union Hospital Cancer Program at Union Hospital
🇺🇸Elkton, Maryland, United States
Woman's Hospital
🇺🇸Baton Rouge, Louisiana, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
🇺🇸Dearborn, Michigan, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
Foote Memorial Hospital
🇺🇸Jackson, Michigan, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
St. Mary Mercy Hospital
🇺🇸Livonia, Michigan, United States
St. Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital
🇺🇸Port Huron, Michigan, United States
University of Mississippi Cancer Clinic
🇺🇸Jackson, Mississippi, United States
Seton Cancer Institute at Saint Mary's - Saginaw
🇺🇸Saginaw, Michigan, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
🇺🇸Saint Louis, Missouri, United States
Saint Louis University Cancer Center
🇺🇸Saint Louis, Missouri, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Cancer Resource Center - Lincoln
🇺🇸Lincoln, Nebraska, United States
Cancer Institute of New Jersey at Cooper - Voorhees
🇺🇸Voorhees, New Jersey, United States
Jersey Shore Cancer Center at Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
🇺🇸New York, New York, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Stony Brook University Cancer Center
🇺🇸Stony Brook, New York, United States
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
McDowell Cancer Center at Akron General Medical Center
🇺🇸Akron, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
Cleveland Clinic Cancer Center at Fairview Hospital
🇺🇸Cleveland, Ohio, United States
Mount Carmel Health - West Hospital
🇺🇸Columbus, Ohio, United States
Hillcrest Cancer Center at Hillcrest Hospital
🇺🇸Mayfield Heights, Ohio, United States
Oklahoma University Cancer Institute
🇺🇸Oklahoma City, Oklahoma, United States
Cancer Care Associates - Midtown Tulsa
🇺🇸Tulsa, Oklahoma, United States
Lake/University Ireland Cancer Center
🇺🇸Mentor, Ohio, United States
Cancer Center of Paoli Memorial Hospital
🇺🇸Paoli, Pennsylvania, United States
Marshfield Clinic - Indianhead Center
🇺🇸Rice Lake, Wisconsin, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
🇺🇸Reading, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Marshfield Clinic - Weston Center
🇺🇸Weston, Wisconsin, United States
CCOP - MainLine Health
🇺🇸Wynnewood, Pennsylvania, United States
Sanford Cancer Center at Sanford USD Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
🇺🇸Hartford, Connecticut, United States
Marshfield Clinic - Marshfield Center
🇺🇸Marshfield, Wisconsin, United States
Harrington Cancer Center
🇺🇸Amarillo, Texas, United States
Saint Joseph Mercy Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Methodist Estabrook Cancer Center
🇺🇸Omaha, Nebraska, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States