Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer

NCT ID: NCT00511992

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2015-08-03

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.

Conditions

Advanced Ovarian Carcinoma; Primary Peritoneal Carcinoma; Ovarian Carcinosarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Avastin

Group Type: EXPERIMENTAL

Avastin

Intervention Type: DRUG

Initial Treatment Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2)

Consolidation Treatment:

Avastin 15mg/kg IV every 21 days x 12 cycles

Paclitaxel

Intervention Type: DRUG

Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles

Cisplatin

Intervention Type: DRUG

75mg/m2 IP day 2 every 21 days x 6 cycles

Interventions

Avastin

Initial Treatment Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2)

Consolidation Treatment:

Avastin 15mg/kg IV every 21 days x 12 cycles

Intervention Type: DRUG

Paclitaxel

Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles

Intervention Type: DRUG

Cisplatin

75mg/m2 IP day 2 every 21 days x 6 cycles

Intervention Type: DRUG

Other Intervention Names

Bevacizumab

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

D. Scott McMeekin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Countries

United States

Other Identifiers

2674

Identifier Type: -

Identifier Source: org_study_id