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

David O'Malley

Status and phase: Completed; Phase 2

Conditions: Endometrial Cancer

Treatments: Drug: bevacizumab; Drug: Paclitaxel; Drug: Carboplatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00513786

OSU-06133

NCI-2012-01229 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

carboplatin/paclitaxel with bevacizumab

Experimental group

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.

Treatment:

Drug: Carboplatin

Drug: Paclitaxel

Drug: bevacizumab