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Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer

Phase 2
Completed
Conditions
Advanced Ovarian Carcinoma
Primary Peritoneal Carcinoma
Ovarian Carcinosarcoma
Interventions
Registration Number
NCT00511992
Lead Sponsor
University of Oklahoma
Brief Summary

The purpose of this study is to evaluate the tolerability of intraperitoneal cisplatin with intravenous paclitaxel and Avastin as defined by the proportion of patients able to complete 6 cycles of treatment.

Detailed Description

Ovarian cancer is the leading cause of death from gynecologic cancer in the United States. The high death rate stems from late presentation and tumor that has spread beyond the ovary at the time of diagnoses.

Ovarian cancer typically spreads throughout the peritoneal cavity. Three randomized clinical trial have recently demonstrated the superiority of intraperitoneal(IP) over intravenous platinum based chemotherapy in optimally debulked advance ovarian cancer. The success of Bevacizumab in metastatic colorectal cancer has led to trials evaluating its' efficacy in advanced ovarian cancer. Based on the mechanism of action of Bevacizumab, there may be benefit of extended therapy with this agent.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
20
Inclusion Criteria
  • Patients with stage II and III epithelial ovarian carcinoma, primary peritoneal carcinoma, or ovarian carcinosarcoma.
  • Adequate bone marrow, renal, and hepatic function
  • Patients must be entered no more than twelve weeks postoperatively
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Exclusion Criteria
  • Patients with epithelial ovarian carcinoma of low malignant potential (borderline carcinomas).
  • Stage IV or suboptimally debulked disease following primary cytoreductive surgery
  • Patients who have received prior radiotherapy or chemotherapy.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
AvastinAvastin-
AvastinCisplatin-
AvastinPaclitaxel-
Primary Outcome Measures
NameTimeMethod
Number of Patients Able to Complete 6 Cycles of Treatment.2 years

Completion of cycle 6

Secondary Outcome Measures
NameTimeMethod
Number of Patients Who Experienced Toxicities Associated With Intraperitoneal Cisplatin With Intravenous Paclitaxel and Avastin.2 years

CTCAE assessment of toxicity

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center

🇺🇸

Oklahoma City, Oklahoma, United States

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