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.
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.
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
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There are 71 Locations for this study
Hartford Connecticut, 06105, United States
New Britain Connecticut, 06050, United States
Lewes Delaware, 19958, United States
Newark Delaware, 19713, United States
Washington District of Columbia, 20010, United States
Augusta Georgia, 30912, United States
Aurora Illinois, 60507, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60612, United States
Hinsdale Illinois, 60521, United States
Joliet Illinois, 60435, United States
Park Ridge Illinois, 60068, United States
Urbana Illinois, 61801, United States
Urbana Illinois, 61801, United States
Michigan City Indiana, 46360, United States
Iowa City Iowa, 52242, United States
Baton Rouge Louisiana, 70815, United States
Elkton Maryland, 21921, United States
Boston Massachusetts, 02111, United States
Worcester Massachusetts, 01655, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48106, United States
Dearborn Michigan, 48123, United States
Flint Michigan, 48503, United States
Flint Michigan, 48503, United States
Grosse Pointe Woods Michigan, 48236, United States
Jackson Michigan, 49201, United States
Kalamazoo Michigan, 49001, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49007, United States
Lansing Michigan, 48912, United States
Livonia Michigan, 48154, United States
Pontiac Michigan, 48341, United States
Port Huron Michigan, 48060, United States
Royal Oak Michigan, 48073, United States
Saginaw Michigan, 48601, United States
Warren Michigan, 48093, United States
Jackson Mississippi, 39216, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63110, United States
Springfield Missouri, 65802, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65807, United States
Lincoln Nebraska, 68510, United States
Omaha Nebraska, 68106, United States
Omaha Nebraska, 68114, United States
Neptune New Jersey, 07754, United States
Voorhees New Jersey, 08043, United States
Brooklyn New York, 11203, United States
New York New York, 10032, United States
Stony Brook New York, 11794, United States
Chapel Hill North Carolina, 27599, United States
Charlotte North Carolina, 28232, United States
Winston-Salem North Carolina, 27157, United States
Akron Ohio, 44307, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44111, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43222, United States
Mayfield Heights Ohio, 44124, United States
Mentor Ohio, 44060, United States
Oklahoma City Oklahoma, 73104, United States
Tulsa Oklahoma, 74104, United States
Abington Pennsylvania, 19001, United States
Bryn Mawr Pennsylvania, 19010, United States
Hershey Pennsylvania, 17033, United States
Paoli Pennsylvania, 19301, United States
Philadelphia Pennsylvania, 19111, United States
Reading Pennsylvania, 19612, United States
Wynnewood Pennsylvania, 19096, United States
Wynnewood Pennsylvania, 19096, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57117, United States
Amarillo Texas, 79106, United States
Marshfield Wisconsin, 54449, United States
Rice Lake Wisconsin, 54868, United States
Weston Wisconsin, 54476, United States
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