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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Evaluate patients with progression free survival (PFS)
Secondary Outcome
To estimate overall survival and objective tumor response using modified RECIST (Response Evaluation Criteria in Solid Tumors) criteria
Condition
Endometrial Cancer
Intervention
Carboplatin
Study Arms / Comparison Groups
carboplatin/paclitaxel with bevacizumab
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
38
Start Date
August 1, 2007
Completion Date
January 3, 2017
Primary Completion Date
January 3, 2017
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
David O'Malley, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00513786
Organization ID
OSU-06133
Secondary IDs
NCI-2012-01229
Responsible Party
Sponsor-Investigator
Study Sponsor
David O'Malley
Collaborators
Genentech, Inc.
Study Sponsor
David O'Malley, MD, Principal Investigator, The Ohio State University Division of Gyn Oncology
Verification Date
July 2017