Clinical trial NCT00072267 (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: 7-hydroxystaurosporine, topotecan hydrochloride
SMILES: [H][C@]1(O)N=C(O)C2=C3C4=CC=CC=C4N4C3=C3N(C5=CC=CC=C5C3=C12)[C@@]1(C)O[C@]4([H])C[C@@]([H])(NC)[C@@]1([H])OC, 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 or cytologically confirmed ovarian epithelial, primary peritoneal, or
             fallopian tube cancer

               -  Progressive, persistent, or recurrent disease

          -  Measurable disease outside prior radiotherapy field unless disease progression
             occurred after radiotherapy

          -  Tumor lesions accessible for biopsy

               -  Patients with a medical contraindication to tumor biopsy may be allowed at the
                  discretion of the principal investigator

          -  No more than 2 prior chemotherapy regimens

               -  At least 1 regimen must have contained a platinum agent (i.e., carboplatin or
                  cisplatin)

          -  No known brain metastases

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  ECOG 0-2 OR

          -  Karnofsky 60-100%

        Life expectancy

          -  More than 12 weeks

        Hematopoietic

          -  WBC at least 3,000/mm^3

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

        Hepatic

          -  Bilirubin no greater than upper limit of normal (ULN)

          -  AST/ALT no greater than 2.5 times ULN

        Renal

          -  Creatinine no greater than ULN OR

          -  Creatinine clearance at least 50 mL/min

        Cardiovascular

          -  No history of coronary artery disease

          -  No symptomatic cardiac dysfunction

          -  No cardiac pathology by electrocardiogram* NOTE: *Patients with symptomatic coronary
             artery disease must undergo an electrocardiogram

        Pulmonary

          -  No symptomatic pulmonary dysfunction

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for at least 8 weeks
             after study participation

          -  No prior allergic reaction attributed to compounds of similar chemical or biological
             composition to UCN-01 or other study agents

          -  No insulin-dependent diabetes mellitus

               -  Diabetes controlled by diet or oral hypoglycemic agents allowed at the discretion
                  of the investigator

          -  No other concurrent uncontrolled illness

          -  No ongoing or active infection

          -  No psychiatric illness or social situation that would preclude study compliance

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  More than 4 weeks since prior biologic therapy and recovered

        Chemotherapy

          -  See Disease Characterisitcs

          -  More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and
             recovered

          -  No prior topotecan

          -  No other prior topoisomerase I inhibitors

        Endocrine therapy

          -  More than 4 weeks since prior hormonal therapy and recovered

        Radiotherapy

          -  See Disease Characteristics

          -  More than 4 weeks since prior radiotherapy and recovered

          -  No prior radiotherapy to more than 40% of bone marrow

          -  No prior mediastinal irradiation

        Surgery

          -  More than 4 weeks since prior surgery and recovered

        Other

          -  No other concurrent anticancer therapy

          -  No other concurrent investigational agents

          -  No concurrent combination antiretroviral therapy for HIV-positive patients