Clinical trial NCT00114166 (phase 2, status: completed)
Conditions: fallopian tube cancer, ovarian cancer, primary peritoneal cavity cancer
ICD codes: C57.00, C57.01, C57.02, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C30.0, Z12.81, D14.0, C14.8, D37.09, Z86.003, Z85.818
Drugs: topotecan hydrochloride
SMILES: CC[C@@]1(O)C(=O)OCC2=C1C=C1N(CC3=CC4=C(C=CC(O)=C4CN(C)C)N=C13)C2=O
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