topotecan in treating patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer

Conditions: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity 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.

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

Keywords: recurrent ovarian epithelial cancer fallopian tube cancer primary peritoneal cavity cancer