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

Phase 2
18 Years
Open (Enrolling)
Endometrial Cancer

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Trial Information

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

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.

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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the progression free survival and determine toxicity profile as assessed by NCI Common Toxicity Criteria for Adverse Events 3.0

Outcome Time Frame:

24 monthes

Safety Issue:


Principal Investigator

David O'Malley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Ohio State University Division of Gyn Oncology


United States: Food and Drug Administration

Study ID:




Start Date:

August 2007

Completion Date:

August 2012

Related Keywords:

  • Endometrial Cancer
  • Endometrial Cancer
  • Advanced Stage Endometrial Cancer
  • Stage 3 or 4 endometrial cancer
  • Cancer treatment
  • gyn cancer
  • Carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



Ohio State University-Division of Gyn Oncology Columbus, Ohio  43210