Evaluation of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Ohio State University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
David O'Malley, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00513786
First received: August 8, 2007
Last updated: May 3, 2012
Last verified: May 2012

August 8, 2007
May 3, 2012
August 2007
August 2012   (final data collection date for primary outcome measure)
To assess the progression free survival and determine toxicity profile as assessed by NCI Common Toxicity Criteria for Adverse Events 3.0 [ Time Frame: 24 monthes ] [ Designated as safety issue: No ]
To assess the progression free survival and determine toxicity profile as assessed by NCI Common Toxicity Criteria for Adverse Events 3.0 [ Time Frame: 24 monthes ]
Complete list of historical versions of study NCT00513786 on ClinicalTrials.gov Archive Site
To estimate overall survival and objective tumor response using modified RECIST criteria [ Time Frame: 2011 ] [ Designated as safety issue: No ]
To estimate overall survival and objective tumor response using modified RECIST criteria [ Time Frame: 2011 ]
Not Provided
Not Provided
 
Evaluation of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma
A Phase II Study of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma

Purpose of this study is to determine the effectiveness of the drug combination carboplatin, paclitaxel, and bevacizumab(Avastin) in patients with advanced stage endometrial carcinoma.

The purpose of this study is to test the effectiveness, safety, and tolerability of the drug combination carboplatin, paclitaxel, and bevacizumab(Avastin) in patients with advanced stage endometrial carcinoma. This is a phase II,open label,single center study. Patients will receive carboplatin, paclitaxel, and bevacizumab in an outpatient center by intravenous administration. The primary objectives is to study the progression free survival at 24 months after initiation of treatment and to determine the toxicity profile of the drug combinations. The secondary objectives are to estimate the overall survival and tumor response for this group of patients.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Endometrial Cancer
Drug: Carboplatin/Paclitaxel/Bevacizumab
Carboplatin (AUC5) IV, Paclitaxel 175mg/m2 IV over 3 hours Bevacizumab 15mg/m2 IV every three weeks for 6 cycles
Other Name: Bevacizumab, Avastin,
Not Provided
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
38
August 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Advanced Stage Endometrial Cancer (Stage 3 or 4)
  • Any Histology including clear cell, and serous papillary carcinomas
  • surgery must have had hysterectomy and bilateral salpingo-oophorectomy
  • chemotherapy initiated 12 weeks after surgery
  • sign informed consent
  • Adequate End-organ function
  • GOG Performance Status 0,1,2
  • Patients must be 18 years or older
  • Patients may have received radiation for the treatment of endometrial cancer.
  • Patients may have measurable or non-measurable disease.

Exclusion Criteria:

  • Patient with concomitant malignancy other than non-melanoma skin cancer
  • Patients with prior malignancy who have been disease free for 5 years.
  • Patients with serious uncontrolled infection, angina or serious peripheral neuropathy.
  • Patients whose circumstances will not permit study completion or adequate follow up
  • Patients who have received prior cytotoxic chemotherapy for treatment of endometrial cancer including chemotherapy used for radiation sensitization.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00513786
2007CO008
Yes
David O'Malley, The Ohio State University
David O'Malley
Genentech, Inc.
Principal Investigator: David O'Malley, MD The Ohio State University Division of Gyn Oncology
Ohio State University
May 2012

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