- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00114166
Topotecan in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
A Randomized Phase II Evaluation of Topotecan (NSC #609699) Administered Daily x 5 Every 3 Weeks vs Weekly Topotecan in the Treatment of Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Connecticut
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Hartford, Connecticut, United States, 06105
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
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New Britain, Connecticut, United States, 06050
- George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
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Delaware
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Lewes, Delaware, United States, 19958
- Tunnell Cancer Center at Beebe Medical Center
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Newark, Delaware, United States, 19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Washington Cancer Institute at Washington Hospital Center
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Georgia
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Augusta, Georgia, United States, 30912
- MBCCOP - Medical College of Georgia Cancer Center
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Illinois
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Aurora, Illinois, United States, 60507
- Rush-Copley Cancer Care Center
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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Chicago, Illinois, United States, 60612-7243
- University of Illinois Cancer Center
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Hinsdale, Illinois, United States, 60521
- Hinsdale Hematology Oncology Associates
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Joliet, Illinois, United States, 60435
- Joliet Oncology-Hematology Associates, Limited - West
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Park Ridge, Illinois, United States, 60068-1174
- Advocate Lutheran General Cancer Care Center
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Urbana, Illinois, United States, 61801
- Carle Cancer Center at Carle Foundation Hospital
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Urbana, Illinois, United States, 61801
- CCOP - Carle Cancer Center
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Indiana
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Michigan City, Indiana, United States, 46360
- Saint Anthony Memorial Health Centers
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Iowa
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Iowa City, Iowa, United States, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
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Louisiana
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Baton Rouge, Louisiana, United States, 70815
- Woman's Hospital
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Maryland
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Elkton, Maryland, United States, 21921
- Union Hospital Cancer Program at Union Hospital
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Tufts-NEMC Cancer Center
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Worcester, Massachusetts, United States, 01655
- UMASS Memorial Cancer Center - University Campus
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Michigan
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Ann Arbor, Michigan, United States, 48106-0995
- Saint Joseph Mercy Cancer Center
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Ann Arbor, Michigan, United States, 48106
- CCOP - Michigan Cancer Research Consortium
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Dearborn, Michigan, United States, 48123-2500
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
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Flint, Michigan, United States, 48503
- Hurley Medical Center
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Flint, Michigan, United States, 48503
- Genesys Hurley Cancer Institute
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Grosse Pointe Woods, Michigan, United States, 48236
- Van Elslander Cancer Center at St. John Hospital and Medical Center
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Jackson, Michigan, United States, 49201
- Foote Memorial Hospital
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Kalamazoo, Michigan, United States, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, United States, 49001
- Borgess Medical Center
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Kalamazoo, Michigan, United States, 49007-3731
- West Michigan Cancer Center
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Lansing, Michigan, United States, 48912-1811
- Sparrow Regional Cancer Center
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Livonia, Michigan, United States, 48154
- St. Mary Mercy Hospital
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Pontiac, Michigan, United States, 48341-2985
- St. Joseph Mercy Oakland
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Port Huron, Michigan, United States, 48060
- Mercy Regional Cancer Center at Mercy Hospital
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Royal Oak, Michigan, United States, 48073
- William Beaumont Hospital - Royal Oak Campus
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Saginaw, Michigan, United States, 48601
- Seton Cancer Institute at Saint Mary's - Saginaw
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Warren, Michigan, United States, 48093
- St. John Macomb Hospital
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Mississippi
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Jackson, Mississippi, United States, 39216
- University of Mississippi Cancer Clinic
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Missouri
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Saint Louis, Missouri, United States, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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Saint Louis, Missouri, United States, 63110
- Saint Louis University Cancer Center
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Springfield, Missouri, United States, 65802
- CCOP - Cancer Research for the Ozarks
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Springfield, Missouri, United States, 65804
- St. John's Regional Health Center
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Springfield, Missouri, United States, 65807
- Hulston Cancer Center at Cox Medical Center South
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Nebraska
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Lincoln, Nebraska, United States, 68510
- Cancer Resource Center - Lincoln
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Omaha, Nebraska, United States, 68106
- CCOP - Missouri Valley Cancer Consortium
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Omaha, Nebraska, United States, 68114
- Methodist Estabrook Cancer Center
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New Jersey
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Neptune, New Jersey, United States, 07754-0397
- Jersey Shore Cancer Center at Jersey Shore University Medical Center
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Voorhees, New Jersey, United States, 08043
- Cancer Institute of New Jersey at Cooper - Voorhees
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New York
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Brooklyn, New York, United States, 11203
- SUNY downstate Medical Center
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New York, New York, United States, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
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Stony Brook, New York, United States, 11794-9446
- Stony Brook University Cancer Center
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North Carolina
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Chapel Hill, North Carolina, United States, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Charlotte, North Carolina, United States, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
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Winston-Salem, North Carolina, United States, 27157-1096
- Wake Forest University Comprehensive Cancer Center
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Ohio
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Akron, Ohio, United States, 44307
- McDowell Cancer Center at Akron General Medical Center
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, United States, 44106-5065
- Case Comprehensive Cancer Center
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Cleveland, Ohio, United States, 44111
- Cleveland Clinic Cancer Center at Fairview Hospital
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Columbus, Ohio, United States, 43214-3998
- Riverside Methodist Hospital Cancer Care
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Columbus, Ohio, United States, 43222
- Mount Carmel Health - West Hospital
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Mayfield Heights, Ohio, United States, 44124
- Hillcrest Cancer Center at Hillcrest Hospital
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Mentor, Ohio, United States, 44060
- Lake/University Ireland Cancer Center
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Oklahoma University Cancer Institute
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Tulsa, Oklahoma, United States, 74104
- Cancer Care Associates - Midtown Tulsa
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Pennsylvania
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Abington, Pennsylvania, United States, 19001
- Rosenfeld Cancer Center at Abington Memorial Hospital
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Bryn Mawr, Pennsylvania, United States, 19010
- Bryn Mawr Hospital
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Hershey, Pennsylvania, United States, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
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Paoli, Pennsylvania, United States, 19301-1792
- Cancer Center of Paoli Memorial Hospital
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Philadelphia, Pennsylvania, United States, 19111-2497
- Fox Chase Cancer Center - Philadelphia
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Reading, Pennsylvania, United States, 19612-6052
- McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
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Wynnewood, Pennsylvania, United States, 19096
- CCOP - MainLine Health
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Wynnewood, Pennsylvania, United States, 19096
- Lankenau Cancer Center at Lankenau Hospital
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South Dakota
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Sioux Falls, South Dakota, United States, 57105
- Avera Cancer Institute
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Sioux Falls, South Dakota, United States, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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Texas
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Amarillo, Texas, United States, 79106
- Harrington Cancer Center
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Wisconsin
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Marshfield, Wisconsin, United States, 54449
- Marshfield Clinic - Marshfield Center
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Rice Lake, Wisconsin, United States, 54868
- Marshfield Clinic - Indianhead Center
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Weston, Wisconsin, United States, 54476
- Marshfield Clinic - Weston Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer
- Recurrent disease
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- At least 1 target lesion not in a previously irradiated field
Received 1, and only 1, prior platinum-based chemotherapy regimen for primary disease containing carboplatin, cisplatin, or other organoplatinum compound
- Initial treatment may have included high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment
- Patients who have not received prior paclitaxel may receive a second regimen that includes paclitaxel
Platinum-sensitive disease
- Treatment-free interval* without clinical evidence of progressive disease for > 6 months after prior response to a platinum-based regimen NOTE: *Non-platinum maintenance or consolidation therapy is not included in calculation of the treatment-free interval
- Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- GOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- SGOT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
Renal
- Creatinine ≤ 1.5 times ULN
- Creatinine clearance > 40 mL/min
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No sensory or motor neuropathy > grade 1
- No active infection requiring antibiotics
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 3 weeks since prior biologic or immunologic agents for the malignancy
- No more than 1 prior non-cytotoxic (biologic or cytostatic) regimen (e.g., monoclonal antibodies, cytokines, or small molecule inhibitors of signal transduction) for recurrent disease
- No concurrent cytokines during the first course of study treatment
- No concurrent pegfilgrastim
Chemotherapy
- See Disease Characteristics
- See Biologic therapy
- Recovered from prior chemotherapy
- No other prior cytotoxic chemotherapy for recurrent disease, including retreatment with initial chemotherapy regimen
- No prior topotecan
Endocrine therapy
- At least 1 week since prior hormonal therapy for the malignancy
- Concurrent hormone replacement therapy allowed
Radiotherapy
- See Disease Characteristics
- Recovered from prior radiotherapy
- No prior radiotherapy to > 25% of marrow-bearing areas
Surgery
- Recovered from prior surgery
Other
- At least 3 weeks since other prior therapy for the malignancy
- No prior anticancer therapy that would preclude study treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Topotecan 1.25 mg/m2 IV days 1-5 of a 21 day cycle
Topotecan 1.25 mg/m2 IV days 1-5 of a 21 day cycle until disease progression or adverse effects prohibit further therapy
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|
Active Comparator: Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28 day cycle
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Tumor Response
Time Frame: 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. |
Every other cycle for the first 6 months, then every 3 months x2, then every 6 months until disease progression or study withdrawal
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Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0
Time Frame: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
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Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reason Off Study Therapy
Time Frame: study entry through end of study treatment, up to 5 years
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study entry through end of study treatment, up to 5 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Thomas J. Herzog, MD, Herbert Irving Comprehensive Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GOG-0146Q
- CDR0000434848
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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