Evaluation of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma - Full Text View

Sponsors and Collaborators:	Ohio State University Genentech
Information provided by:	Ohio State University
ClinicalTrials.gov Identifier:	NCT00513786

Purpose

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.

Condition	Intervention	Phase
Endometrial Cancer	Drug: Carboplatin/Paclitaxel/Bevacizumab	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Carboplatin Paclitaxel Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma

Further study details as provided by Ohio State University:

Primary Outcome Measures:

To assess the progression free survival and determine toxicity profile as assessed by NCI Common Toxicity Criteria for Adverse Events 3.0 [ Time Frame: 24 monthes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To estimate overall survival and objective tumor response using modified RECIST criteria [ Time Frame: 2011 ] [ Designated as safety issue: No ]

Estimated Enrollment:	38
Study Start Date:	August 2007
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Carboplatin (AUC5) IV, Paclitaxel 175mg/m2 IV over 3 hours Bevacizumab 15mg/m2 IV every three weeks for 6 cycles

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00513786

Contacts

Contact: Melissa Nelson, RN	614-442-1581	melissa.nelson2@osumc.edu
Contact: Michele Vaughan, Research	614-442-3101	michele.vaughan@osumc.edu

Locations

United States, Ohio
Ohio State University-Division of Gyn Oncology	Recruiting
Columbus, Ohio, United States, 43210
Contact: Melissa Nelson, RN 614-442-1581 melissa.nelson2@osumc.edu
Contact: Michele Vaughan, Research 614-442-3101 michele.vaughan@osumc.edu
Principal Investigator: David O'Malley, MD

Sponsors and Collaborators

Ohio State University

Genentech

Investigators

Principal Investigator:

David O'Malley, MD

The Ohio State University Division of Gyn Oncology

More Information

Responsible Party:	The Ohio State University, Gyn Oncology ( David O'Malley, MD )
Study ID Numbers:	2007CO008
Study First Received:	August 8, 2007
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00513786
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ohio State University:

Endometrial Cancer
Advanced Stage Endometrial Cancer
Stage 3 or 4 endometrial cancer
Cancer treatment
gyn cancer

Study placed in the following topic categories:

Genital Diseases, Female
Endometrial Neoplasms
Paclitaxel
Genital Neoplasms, Female
Uterine Diseases
Uterine Neoplasms

Urogenital Neoplasms
Carboplatin
Bevacizumab
Endometrial cancer
Carcinoma

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents
Angiogenesis Inhibitors
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 15, 2009