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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
David O'Malley, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00513786
First received: August 8, 2007
Last updated: July 25, 2015
Last verified: July 2015

August 8, 2007
July 25, 2015
August 2007
November 2016   (final data collection date for primary outcome measure)
Evaluate patients with progression free survival (PFS) [ Time Frame: up to 24 months ] [ 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 (Response Evaluation Criteria in Solid Tumors) criteria [ Time Frame: up to 24 months ] [ Designated as safety issue: Yes ]
  • Number of patients with Adverse events as a measure of safety and tolerability. [ Time Frame: up to 24 months ] [ Designated as safety issue: Yes ]
    Toxicities will be assessed by using the NCI Common Toxicity Criteria for Adverse Events 3.0
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
    AUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles.
    Other Names:
    • Paraplatin
    • CBDCA
  • Drug: Paclitaxel
    175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles.
    Other Names:
    • Onxol
    • Taxol
  • Drug: bevacizumab
    15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles.
    Other Name: Avastin
Experimental: carboplatin/paclitaxel with bevacizumab
A regimen of Carboplatin and paclitaxel combined with bevacizumab given every 21 days in patients with advanced stage endometrial cancer for a maximum of 6 cycles.
Interventions:
  • Drug: Carboplatin
  • Drug: Paclitaxel
  • Drug: bevacizumab
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
Not Provided
November 2016   (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 (Gynecologic Oncology Group)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
OSU-06133, NCI-2012-01229
Yes
David O'Malley, Ohio State University Comprehensive Cancer Center
David O'Malley
Genentech, Inc.
Principal Investigator: David O'Malley, MD The Ohio State University Division of Gyn Oncology
Ohio State University Comprehensive Cancer Center
July 2015

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