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

Primary Purpose

Endometrial Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Carboplatin
Paclitaxel
bevacizumab
Sponsored by
David O'Malley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring Endometrial Cancer, Advanced Stage Endometrial Cancer, Stage 3 or 4 endometrial cancer, Cancer treatment, gyn cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Ohio State University-Division of Gyn Oncology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

carboplatin/paclitaxel with bevacizumab

Arm Description

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.

Outcomes

Primary Outcome Measures

Evaluate patients with progression free survival (PFS)

Secondary Outcome Measures

To estimate overall survival and objective tumor response using modified RECIST (Response Evaluation Criteria in Solid Tumors) criteria
Number of patients with Adverse events as a measure of safety and tolerability.
Toxicities will be assessed by using the NCI Common Toxicity Criteria for Adverse Events 3.0

Full Information

First Posted
August 8, 2007
Last Updated
July 28, 2017
Sponsor
David O'Malley
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00513786
Brief Title
Evaluation of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma
Official Title
A Phase II Study of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 1, 2007 (Actual)
Primary Completion Date
January 3, 2017 (Actual)
Study Completion Date
January 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David O'Malley
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
Endometrial Cancer, Advanced Stage Endometrial Cancer, Stage 3 or 4 endometrial cancer, Cancer treatment, gyn cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
carboplatin/paclitaxel with bevacizumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin, CBDCA
Intervention Description
AUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Onxol, Taxol
Intervention Description
175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles.
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles.
Primary Outcome Measure Information:
Title
Evaluate patients with progression free survival (PFS)
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
To estimate overall survival and objective tumor response using modified RECIST (Response Evaluation Criteria in Solid Tumors) criteria
Time Frame
up to 24 months
Title
Number of patients with Adverse events as a measure of safety and tolerability.
Description
Toxicities will be assessed by using the NCI Common Toxicity Criteria for Adverse Events 3.0
Time Frame
up to 24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David O'Malley, MD
Organizational Affiliation
The Ohio State University Division of Gyn Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University-Division of Gyn Oncology
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

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

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