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Completed

NCT Number: NCT00513786

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

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.

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Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

The Ohio State University-Division of Gyn Oncology

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

carboplatin

Drug

AUC (area under curve) 5 Intervenous (IV) over 30 minutes given every 21 days for a maximum of 6 cycles.

Other names: Paraplatin, CBDCA

paclitaxel

Drug

175 mg/m2 over 3 hours given every 21 days for a maximum of 6 cycles.

Other names: Onxol, Taxol

Bevacizumab

Drug

15 mg/kg intervenous (IV) given every 21 days for a maximum of 6 cycles.

Other names: Avastin

Primary outcomes

  1. Evaluate Patients With Progression Free Survival (PFS)

    Time frame: up to 57 months

    Progressive Disease (PD) is defined at least a 20% increase in the sum of the longest dimension of target lesions, taking as reference the smallest sum of the longest dimension recorded since the treatment start or the appearance of one or more new lesions.

Secondary outcomes

  1. To Estimate Overall Survival

    Time frame: up to 24 months

  2. 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

  3. Objective Tumor Response Using Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria

    Time frame: Up to 24 months

    Tumor response will be evaluated using modified RECIST criteria with the following definitions. Complete Response (CR) is disappearance of gross evidence of disease with confirmation at least 4 weeks later. Partial Response (PR) is a 30% or greater reduction in measurement of longest dimension of each lesion with confirmation at least 4 weeks later. Progressive Disease (PD) is at least a 20% increase in the sum of the longest dimension of target lesions, taking as reference the smallest sum of the longest dimension recorded since the treatment start or the appearance of one or more new lesions. Stable Disease (SD) is any condition not meeting the other criteria for CR, PR or PD.

Sponsors and collaborators

Lead sponsor

David O'Malley

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2017
Study completion
2017
First posted
Aug 9, 2007
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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