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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00513786
First Posted: August 9, 2007
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
David O'Malley, Ohio State University Comprehensive Cancer Center
  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 Drug: Paclitaxel Drug: bevacizumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Carboplatin/Paclitaxel/Bevacizumab in the Treatment of Advanced Stage Endometrial Carcinoma

Resource links provided by NLM:


Further study details as provided by David O'Malley, Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Evaluate patients with progression free survival (PFS) [ Time Frame: up to 24 months ]

Secondary Outcome Measures:
  • To estimate overall survival and objective tumor response using modified RECIST (Response Evaluation Criteria in Solid Tumors) criteria [ Time Frame: up to 24 months ]
  • Number of patients with Adverse events as a measure of safety and tolerability. [ Time Frame: up to 24 months ]
    Toxicities will be assessed by using the NCI Common Toxicity Criteria for Adverse Events 3.0


Enrollment: 38
Actual Study Start Date: August 1, 2007
Study Completion Date: January 3, 2017
Primary Completion Date: January 3, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: carboplatin/paclitaxel with bevacizumab
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.
Drug: Carboplatin
AUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles.
Other Names:
  • Paraplatin
  • CBDCA
Drug: Paclitaxel
175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles.
Other Names:
  • Onxol
  • Taxol
Drug: bevacizumab
15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles.
Other Name: Avastin

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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 (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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00513786


Locations
United States, Ohio
Ohio State University-Division of Gyn Oncology
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
David O'Malley
Genentech, Inc.
Investigators
Principal Investigator: David O'Malley, MD The Ohio State University Division of Gyn Oncology
  More Information

Additional Information:
Responsible Party: David O'Malley, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00513786     History of Changes
Other Study ID Numbers: OSU-06133
NCI-2012-01229 ( Registry Identifier: Clinical Trials Reporting Program (CTRP) )
First Submitted: August 8, 2007
First Posted: August 9, 2007
Last Update Posted: August 1, 2017
Last Verified: July 2017

Keywords provided by David O'Malley, Ohio State University Comprehensive Cancer Center:
Endometrial Cancer
Advanced Stage Endometrial Cancer
Stage 3 or 4 endometrial cancer
Cancer treatment
gyn cancer

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Paclitaxel
Albumin-Bound Paclitaxel
Bevacizumab
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors