Clinical trial NCT00513786: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometrial Cancer
Keywords: Endometrial Cancer
Advanced Stage Endometrial Cancer
Stage 3 or 4 endometrial cancer
Cancer treatment
gyn cancer
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2007-08-09
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Evaluate Patients With Progression Free Survival (PFS)
timeFrame: up to 57 months
Secondary outcomes:
measure: To Estimate Overall Survival
timeFrame: up to 24 months
measure: Number of Patients With Adverse Events as a Measure of Safety and Tolerability.
timeFrame: up to 24 months
measure: Objective Tumor Response Using Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University-Division of Gyn Oncology
state: Ohio
Study officials:
affiliation: The Ohio State University Division of Gyn Oncology
name: David O'Malley, MD
role: PRINCIPAL_INVESTIGATOR
References: