Clinical trial NCT00526799 (phase 1/phase 2, status: terminated)
Conditions: ovarian cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: sorafenib, topotecan
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1, CC[C@@]1(O)C(=O)OCC2=C1C=C1N(CC3=CC4=C(C=CC(O)=C4CN(C)C)N=C13)C2=O
Reason stopped: 
    study closed to accrual due unfavorable interim analysis
  
Eligibility criteria:

        Inclusion Criteria:

          -  Have histologically-confirmed epithelial ovarian cancer, primary peritoneal
             carcinomatosis or fallopian tube cancer. Enrollment of patients with clear cell
             histology is encouraged.

          -  Have measurable disease according to RECIST or detectable disease by 1) CA-125 at
             least twice the ULN within 14 days prior to registration for protocol therapy; 2)
             Ascites and/or pleural effusion attributed to tumor; 3) solid and/or cystic
             abnormalities on radiographic imaging that do not meet RECIST definitions for target
             lesions.

          -  Have failed at least one prior platinum based chemotherapeutic regimen.

          -  No more than 3 prior treatment regimens for epithelial ovarian cancer.

          -  Prior radiation therapy is allowed to < 25% of the bone marrow.

          -  Be at least 4 weeks since last anti-cancer treatment, radiation or surgery at the time
             of registration for protocol therapy.

          -  No active cancer in addition to the epithelial ovarian cancer within the last 5 years,
             with the exception of: superficial skin cancer (basal cell or squamous cell skin
             carcinoma; carcinoma in situ of the cervix; Stage I endometrial cancer with less than
             50% invasion of the myometrium, or other adequately treated Stage I or II cancer in
             complete remission.

          -  Age > 18 years at the time of consent

          -  Written informed consent and HIPAA authorization for release of personal health
             information.

          -  Females of childbearing potential must be willing to use an effective method of
             contraception (hormonal or barrier method of birth control; abstinence) from the time
             consent is signed until 90 days after treatment discontinuation

          -  Females of childbearing potential must have a negative pregnancy test within 7 days
             prior to being registered for protocol therapy.

        Exclusion Criteria:

          -  No known or suspected allergy to sorafenib or any agent given in the course of this
             trial.

          -  No prior treatment with anti-angiogenesis therapy.

          -  No active CNS metastases.

          -  No treatment with any investigational agent within 30 days prior to being registered
             for protocol therapy.

          -  No concurrent combination anti-retroviral therapy for the treatment of
             immunodeficiency.

          -  No clinically significant infections requiring antibiotic treatment.

          -  No evidence of bowel obstruction, malabsorption, or other contraindication to oral
             medication.

          -  No serious non-healing wound, ulcer, or bone fracture.

          -  No major surgery, open biopsy or significant traumatic injury within 28 days of
             registration for protocol therapy.

          -  No use of St. John's Wort or rifampin (rifampicin) while on protocol therapy.

          -  No condition that impairs patient's ability to swallow whole pills.