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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
David O'Malley, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00513786
First received: August 8, 2007
Last updated: July 25, 2015
Last verified: July 2015
  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: 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 Comprehensive Cancer Center:

Primary Outcome Measures:
  • Evaluate patients with progression free survival (PFS) [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]
  • Number of patients with Adverse events as a measure of safety and tolerability. [ Time Frame: up to 24 months ] [ Designated as safety issue: Yes ]
    Toxicities will be assessed by using the NCI Common Toxicity Criteria for Adverse Events 3.0


Estimated Enrollment: 38
Study Start Date: August 2007
Estimated Primary Completion Date: November 2016 (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

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 (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
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, Inc.
Investigators
Principal Investigator: David O'Malley, MD The Ohio State University Division of Gyn Oncology
  More Information

Additional Information:
No publications provided

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
Study First Received: August 8, 2007
Last Updated: July 25, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by 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
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Diseases
Uterine Neoplasms
Bevacizumab
Carboplatin
Paclitaxel
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Growth Inhibitors
Growth Substances
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on August 31, 2015