Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer

Primary Peritoneal Carcinoma Clinical Trial

Official title:

PHASE II STUDY OF PACLITAXEL (TAXOL), INTRAPERITONEAL CISPLATIN AND IV AVASTIN FOLLOWED BY AVASTIN CONSOLIDATION FOR ADVANCED OVARIAN AND PERITONEAL CARCINOMA OR FALLOPIAN TUBE CANCER

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00511992
• Other study ID #: 2674
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 3, 2007
• Last updated: May 29, 2015
• Start date: July 2007
• Est. completion date: May 2016

Study information

• Verified date: May 2015
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Ovarian Carcinoma
• Carcinoma
• Carcinosarcoma
• Mixed Tumor, Mullerian
• Neoplasms, Glandular and Epithelial
• Ovarian Carcinosarcoma
• Ovarian Neoplasms
• Primary Peritoneal Carcinoma

Intervention

Drug:
• Avastin
Initial Treatment: Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles, Cisplatin 75mg/m2 IP Day 2 every 21 days x 6 cycles, 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

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating the tolerability of intraperitoneal cisplatin with intravenous paclitaxel and Avastin as defined by the proportion of patients able to complete 6 cycles of treatment.		2 years	Yes
Secondary	Describe toxicities associated with intraperitoneal cisplatin with intravenous paclitaxel and Avastin.		2 years	Yes