Sorafenib + Topotecan for Platinum-Resistant Recurrent Ovarian Cancer

Stopped early · Phase 1/Phase 2

Conditions studied: Ovarian Cancer

In brief

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).

Key facts

Study ID

NCT00526799

Run by

Daniela Matei, MD

People needed

30

Starts

2007-09-01

Expected to finish

2010-08-01

Last updated by the study team

2016-03-03

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Medical & Surgical Specialists, LLC — Galesburg, Illinois, United States
• Oncology Hematology Associates of SW Indiana — Evansville, Indiana, United States
• Fort Wayne Oncology & Hematology, Inc — Fort Wayne, Indiana, United States
• Indiana University Simon Cancer Center — Indianapolis, Indiana, United States
• St. Vincent Hospital Cynecologic Oncology — Indianapolis, Indiana, United States
• Arnett Cancer Care — Lafayette, Indiana, United States
• Medical Consultants, P.C. — Muncie, Indiana, United States
• Schwartz Gynecologic Oncology, PLLC — Brightwaters, New York, United States

Full record on ClinicalTrials.gov

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