A Phase I/II Study of Sorafenib in Combination With Topotecan for the Treatment of Platinum-Resistant Recurrent Ovarian Cancer or Primary Peritoneal Carcinomatosis: Hoosier Oncology Group GYN06-111

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.