Sorafenib + Topotecan for Platinum-Resistant Recurrent Ovarian Cancer

• Status: Terminated
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

This multi-institutional phase I/II clinical trial will test the tolerability and efficacy of the combination sorafenib and topotecan in patients with recurrent ovarian cancer, which is platinum-resistant (recurrence within 6 months from completing platinum based therapy) or refractory (progressive disease during platinum based therapy).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daniela Matei, MD
• Collaborators: Bayer; Hoosier Cancer Research Network
• Treatments: Niacinamide; Sorafenib; Topotecan

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.