A Phase II Study of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Evaluate Patients With Progression Free Survival (PFS)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Carboplatin (Drug)
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.
Intervention: Paclitaxel (Drug)
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.
Intervention: bevacizumab (Drug)
Outcomes
Primary Outcomes
Evaluate Patients With Progression Free Survival (PFS)
Time Frame: up to 57 months
Progressive Disease (PD) is defined at least a 20% increase in the sum of the longest dimension of target lesions, taking as reference the smallest sum of the longest dimension recorded since the treatment start or the appearance of one or more new lesions.
Secondary Outcomes
- To Estimate Overall Survival(up to 24 months)
- Number of Patients With Adverse Events as a Measure of Safety and Tolerability.(up to 24 months)
- Objective Tumor Response Using Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria(Up to 24 months)
Investigators
David O'Malley
Principal Investigator
Ohio State University Comprehensive Cancer Center