Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00511992
First received: August 3, 2007
Last updated: May 20, 2014
Last verified: May 2014

August 3, 2007
May 20, 2014
July 2007
July 2015   (final data collection date for primary outcome measure)
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. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 2 years ]
Complete list of historical versions of study NCT00511992 on ClinicalTrials.gov Archive Site
Describe toxicities associated with intraperitoneal cisplatin with intravenous paclitaxel and Avastin. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Describe toxicities associated with intraperitoneal cisplatin with intravenous paclitaxel and Avastin. [ Time Frame: 2 years ]
Not Provided
Not Provided
 
Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer
Phase II Study of Paclitaxel, Intraperitoneal Cisplatin and IV Bevacizumab Followed by Bevacizumab Consolidation for Advanced Ovarian and Peritoneal Carcinoma

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Advanced Ovarian Carcinoma
  • Primary Peritoneal Carcinoma
  • Ovarian Carcinosarcoma
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

Other Names:
  • Avastin
  • Bevacizumab
Experimental: Avastin
Intervention: Drug: Avastin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
July 2015
July 2015   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00511992
AVF3953 McMeekin
Yes
University of Oklahoma
University of Oklahoma
Genentech
Principal Investigator: D. Scott McMeekin, MD University of Oklahoma
University of Oklahoma
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP