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Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00511992
First received: August 3, 2007
Last updated: June 2, 2017
Last verified: June 2017
August 3, 2007
June 2, 2017
July 2007
August 3, 2015   (Final data collection date for primary outcome measure)
Number of Patients Able to Complete 6 Cycles of Treatment. [ Time Frame: 2 years ]
Completion of cycle 6
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
Number of Patients Who Experienced Toxicities Associated With Intraperitoneal Cisplatin With Intravenous Paclitaxel and Avastin. [ Time Frame: 2 years ]
CTCAE assessment of toxicity
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 (TAXOL), Intraperitoneal Cisplatin and IV Avastin Followed by Avastin Consolidation for Advanced Ovarian and Peritoneal Carcinoma or Fallopian Tube Cancer
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
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
  • Advanced Ovarian Carcinoma
  • Primary Peritoneal Carcinoma
  • Ovarian Carcinosarcoma
  • Drug: 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

    Other Name: Bevacizumab
  • Drug: Paclitaxel
    Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles
  • Drug: Cisplatin
    75mg/m2 IP day 2 every 21 days x 6 cycles
Experimental: Avastin
Interventions:
  • Drug: Avastin
  • Drug: Paclitaxel
  • Drug: Cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 3, 2015
August 3, 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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00511992
2674
Yes
Not Provided
Not Provided
University of Oklahoma
University of Oklahoma
Genentech, Inc.
Principal Investigator: D. Scott McMeekin, MD University of Oklahoma
University of Oklahoma
June 2017

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