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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Ohio State University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
David O'Malley, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00513786
First received: August 8, 2007
Last updated: May 3, 2012
Last verified: May 2012
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Carboplatin/Paclitaxel/Bevacizumab
    Carboplatin (AUC5) IV, Paclitaxel 175mg/m2 IV over 3 hours Bevacizumab 15mg/m2 IV every three weeks for 6 cycles
    Other Name: Bevacizumab, 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: David O'Malley, Assistant Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT00513786     History of Changes
Other Study ID Numbers: 2007CO008
Study First Received: August 8, 2007
Last Updated: May 3, 2012
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

Additional relevant MeSH terms:
Carcinoma
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors
Bevacizumab
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances

ClinicalTrials.gov processed this record on July 29, 2014