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

Endometrial Cancer Clinical Trial

Official title:

A Phase II Study of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00513786
• Other study ID #: OSU-06133
• Secondary ID: NCI-2012-01229
• Status: Completed
• Phase: Phase 2
• First received: August 8, 2007
• Last updated: July 28, 2017
• Start date: August 1, 2007
• Est. completion date: January 3, 2017

Study information

• Verified date: July 2017
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 3, 2017
• Est. primary completion date: January 3, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Drug:
• Carboplatin
AUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles.
• Paclitaxel
175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles.
• bevacizumab
15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles.

Locations

Country	Name	City	State
United States	Ohio State University-Division of Gyn Oncology	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
David O'Malley	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate patients with progression free survival (PFS)		up to 24 months
Secondary	To estimate overall survival and objective tumor response using modified RECIST (Response Evaluation Criteria in Solid Tumors) criteria		up to 24 months
Secondary	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	up to 24 months

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