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

David O'Malley38 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Endometrial Cancer

Interventions

CarboplatinDRUG

AUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles.

PaclitaxelDRUG

175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles.

bevacizumabDRUG

15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Ohio State University-Division of Gyn Oncology

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Evaluate Patients With Progression Free Survival (PFS)

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.

Time frame: up to 57 months

Secondary Outcomes

To Estimate Overall Survival

Time frame: up to 24 months

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

Time frame: up to 24 months

Objective Tumor Response Using Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria

Tumor response will be evaluated using modified RECIST criteria with the following definitions. Complete Response (CR) is disappearance of gross evidence of disease with confirmation at least 4 weeks later. Partial Response (PR) is a 30% or greater reduction in measurement of longest dimension of each lesion with confirmation at least 4 weeks later. Progressive Disease (PD) is 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. Stable Disease (SD) is any condition not meeting the other criteria for CR, PR or PD.

Time frame: Up to 24 months

Data from ClinicalTrials.gov

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