Overview

This trial is active, not recruiting.

Condition endometrial cancer
Treatments carboplatin, paclitaxel, bevacizumab
Phase phase 2
Sponsor David O'Malley
Collaborator Genentech, Inc.
Start date August 2007
End date November 2016
Trial size 38 participants
Trial identifier NCT00513786, NCI-2012-01229, OSU-06133

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
carboplatin Paraplatin
AUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles.
paclitaxel Onxol
175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles.
bevacizumab Avastin
15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles.

Primary Outcomes

Measure
Evaluate patients with progression free survival (PFS)
time frame: up to 24 months

Secondary Outcomes

Measure
To estimate overall survival and objective tumor response using modified RECIST (Response Evaluation Criteria in Solid Tumors) criteria
time frame: up to 24 months
Number of patients with Adverse events as a measure of safety and tolerability.
time frame: up to 24 months

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title A Phase II Study of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma
Principal investigator David O'Malley, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center.