Ovarian Cancer Clinical Trial

Topotecan in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

81

Study ID:

NCT00114166

Recruitment Status:

Completed

Sponsor:

Gynecologic Oncology Group

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There are 71 Locations for this study

See Locations Near You

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford Connecticut, 06105, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain Connecticut, 06050, United States
Tunnell Cancer Center at Beebe Medical Center
Lewes Delaware, 19958, United States
CCOP - Christiana Care Health Services
Newark Delaware, 19713, United States
Washington Cancer Institute at Washington Hospital Center
Washington District of Columbia, 20010, United States
MBCCOP - Medical College of Georgia Cancer Center
Augusta Georgia, 30912, United States
Rush-Copley Cancer Care Center
Aurora Illinois, 60507, United States
University of Illinois Cancer Center
Chicago Illinois, 60612, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Hinsdale Hematology Oncology Associates
Hinsdale Illinois, 60521, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet Illinois, 60435, United States
Advocate Lutheran General Cancer Care Center
Park Ridge Illinois, 60068, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
Saint Anthony Memorial Health Centers
Michigan City Indiana, 46360, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City Iowa, 52242, United States
Woman's Hospital
Baton Rouge Louisiana, 70815, United States
Union Hospital Cancer Program at Union Hospital
Elkton Maryland, 21921, United States
Tufts-NEMC Cancer Center
Boston Massachusetts, 02111, United States
UMASS Memorial Cancer Center - University Campus
Worcester Massachusetts, 01655, United States
Saint Joseph Mercy Cancer Center
Ann Arbor Michigan, 48106, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor Michigan, 48106, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn Michigan, 48123, United States
Genesys Hurley Cancer Institute
Flint Michigan, 48503, United States
Hurley Medical Center
Flint Michigan, 48503, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods Michigan, 48236, United States
Foote Memorial Hospital
Jackson Michigan, 49201, United States
Borgess Medical Center
Kalamazoo Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
Sparrow Regional Cancer Center
Lansing Michigan, 48912, United States
St. Mary Mercy Hospital
Livonia Michigan, 48154, United States
St. Joseph Mercy Oakland
Pontiac Michigan, 48341, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron Michigan, 48060, United States
William Beaumont Hospital - Royal Oak Campus
Royal Oak Michigan, 48073, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw Michigan, 48601, United States
St. John Macomb Hospital
Warren Michigan, 48093, United States
University of Mississippi Cancer Clinic
Jackson Mississippi, 39216, United States
Saint Louis University Cancer Center
Saint Louis Missouri, 63110, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis Missouri, 63110, United States
CCOP - Cancer Research for the Ozarks
Springfield Missouri, 65802, United States
St. John's Regional Health Center
Springfield Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South
Springfield Missouri, 65807, United States
Cancer Resource Center - Lincoln
Lincoln Nebraska, 68510, United States
CCOP - Missouri Valley Cancer Consortium
Omaha Nebraska, 68106, United States
Methodist Estabrook Cancer Center
Omaha Nebraska, 68114, United States
Jersey Shore Cancer Center at Jersey Shore University Medical Center
Neptune New Jersey, 07754, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees New Jersey, 08043, United States
SUNY Downstate Medical Center
Brooklyn New York, 11203, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York New York, 10032, United States
Stony Brook University Cancer Center
Stony Brook New York, 11794, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill North Carolina, 27599, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte North Carolina, 28232, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem North Carolina, 27157, United States
McDowell Cancer Center at Akron General Medical Center
Akron Ohio, 44307, United States
Case Comprehensive Cancer Center
Cleveland Ohio, 44106, United States
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland Ohio, 44111, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
Riverside Methodist Hospital Cancer Care
Columbus Ohio, 43214, United States
Mount Carmel Health - West Hospital
Columbus Ohio, 43222, United States
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights Ohio, 44124, United States
Lake/University Ireland Cancer Center
Mentor Ohio, 44060, United States
Oklahoma University Cancer Institute
Oklahoma City Oklahoma, 73104, United States
Cancer Care Associates - Midtown Tulsa
Tulsa Oklahoma, 74104, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington Pennsylvania, 19001, United States
Bryn Mawr Hospital
Bryn Mawr Pennsylvania, 19010, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Cancer Center of Paoli Memorial Hospital
Paoli Pennsylvania, 19301, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia Pennsylvania, 19111, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading Pennsylvania, 19612, United States
CCOP - MainLine Health
Wynnewood Pennsylvania, 19096, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood Pennsylvania, 19096, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls South Dakota, 57117, United States
Harrington Cancer Center
Amarillo Texas, 79106, United States
Marshfield Clinic - Marshfield Center
Marshfield Wisconsin, 54449, United States
Marshfield Clinic - Indianhead Center
Rice Lake Wisconsin, 54868, United States
Marshfield Clinic - Weston Center
Weston Wisconsin, 54476, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Estimated Enrollment:

81

Study ID:

NCT00114166

Recruitment Status:

Completed

Sponsor:


Gynecologic Oncology Group

How clear is this clinincal trial information?

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