Clinical trial NCT01146795
Conditions: Epithelial Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer
Sponsor: Jason D. Wright
Start date: 2010-05-17; Completion date: 2015-04-13
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is to determine the feasibility of administering neoadjuvant carboplatin, paclitaxel, and bevacizumab without excessive dose modification or cycle delay in patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer. This study will also investigate the rate of optimal cytoreduction, response rate and progression free and overall survival, and to assess the quality of life for patients with epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer treated with neoadjuvant carboplatin, paclitaxel and bevacizumab.

Detailed description:
Initial treatment for ovarian cancer is usually surgical cytoreduction followed by adjuvant platinum and taxane chemotherapy. At the time of diagnosis over 75% of patients present with stage III or IV disease that has spread into the peritoneal cavity or distally. Despite a number of new chemotherapeutic regimens survival has improved only modestly over the preceding two decades. While overall 5-year survival has improved from 30% to 50%, 5-year survival remains only 25% for women with advanced stage disease. Given these findings it is clear that improved strategies for the delivery of cytotoxic and biologic agents are needed for women with advanced stage epithelial ovarian cancer.

A newer drug, called bevacizumab, has been approved by the U.S. Food and Drug Administration (FDA) for use in combination with chemotherapy in patients with colon cancer, lung cancer, and some types of breast cancer that have spread to distant sites in the body. A critical question which will need to be answered is whether or not it is feasible to administer a combination of bevacizumab with standard cytotoxic therapy using a neo-adjuvant approach for patients with epithelial cancer of the ovary, fallopian tube, or primary peritoneum.

Arms: arm 1: Three 21 day cycles of carboplatin, paclitaxel, and bevacizumab.

After 3 cycles of chemotherapy patients will be considered for surgical cytoreduction. Patients must fulfill all criteria to be considered eligible for surgical exploration: 1) ≥50% reduction in pretreatment cancer antigen 125 (CA-125) and 2) No medical contraindications to surgery.

After surgical cytoreduction all patients will receive an additional 6 cycles of chemotherapy (cycles 4-9) regardless of disease status at the time of exploration. Chemotherapy should be re-instituted within 6 weeks of the surgical procedure. Bevacizumab will be omitted from cycle 4 of chemotherapy. Patients who do NOT undergo surgical resection should receive cycles 4-9 of therapy. In this instance bevacizumab may be included in cycle 4.
Interventions: intervention 1: Carboplatin intervention 2: Paclitaxel intervention 3: Bevacizumab
Intervention descriptions: intervention 1: Carboplatin will be administered at a concentration-time curve (AUC) of 5-6 (at the discretion of the physician) day 1 every 3 weeks in combination with Paclitaxel and Bevacizumab. intervention 2: Paclitaxel 175 mg/m2 over 3 hours day 1 every 3 weeks in combination with Carboplatin and Bevacizumab. intervention 3: Bevacizumab 15 mg/kg day 1 every 3 weeks in combination with Paclitaxel and Carboplatin.

Protocol documents: