Topotecan in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Condition: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer
MeSH terms: Fallopian Tube Neoplasms
Intervention: topotecan hydrochloride
Intervention MeSH terms: Topotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: Female
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent ovarian epithelial cancer; fallopian tube 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.
    

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