Doxorubicin Hydrochloride Liposome and Carboplatin in Treating Patients With Recurrent, Stage III, or Stage IV Primary Endometrial Cancer

August 8, 2014 updated by: Roswell Park Cancer Institute

A Multi-center Phase II Study of Doxil®/Carboplatin in Patients With Advanced or Recurrent Endometrial Carcinoma

RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving doxorubicin hydrochloride liposome together with carboplatin works in treating patients with recurrent, stage III, or stage IV primary endometrial cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Estimate the response rate in patients with recurrent or stage III or IV primary endometrial carcinoma treated with doxorubicin hydrochloride liposome and carboplatin.

Secondary

  • Determine progression-free survival of patients treated with this regimen.
  • Determine overall survival of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 6 months and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary endometrial carcinoma meeting 1 of the following criteria:

    • Stage III or IV disease according to FIGO staging criteria
    • Recurrent disease that is considered incurable

  • Measurable disease

    • A lesion within a previously irradiated field is acceptable as measurable disease only if there has been clear progression since completion of radiotherapy

PATIENT CHARACTERISTICS:

  • GOG performance status 0-2
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL
  • Creatinine < 2.5 mg/dL OR creatinine clearance ≥ 60 mL/min
  • ALT and AST ≤ 1.5 times upper limit of normal (ULN) (3 times ULN in the presence of liver metastases)
  • Alkaline phosphatase ≤ 1.5 times ULN (3 times ULN in the presence of liver metastases)
  • Total bilirubin ≤ 1.5 times ULN (3 times ULN in the presence of liver metastases)
  • Not pregnant or nursing
  • Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA scan or ECHO
  • No history of severe hypersensitivity reaction to doxorubicin hydrochloride liposome
  • No other invasive malignancy (i.e., breast cancer) within the past 5 years except nonmelanoma skin cancer

  • No cardiac disease, including any of the following:

    • Myocardial infarction within the past 6 months
    • NYHA class II-IV heart failure
    • Uncontrolled angina
    • Severe uncontrolled ventricular arrhythmias
    • Clinically significant pericardial disease
    • Acute ischemic or active conduction system abnormalities by ECHO

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy
  • No prior cancer therapy that would contraindicate study treatment
  • No concurrent investigational agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Doxorubicin and carboplatin
Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1
Drug: carboplatin
IV
Drug: pegylated liposomal doxorubicin hydrochloride
IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response (Complete and Partial)
Time Frame: Every 28 days
Response Rate
Every 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Investigators

  • Principal Investigator: Shashikant B. Lele, MD, Roswell Park Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

May 3, 2007

First Submitted That Met QC Criteria

May 3, 2007

First Posted (Estimate)

May 7, 2007

Study Record Updates

Last Update Posted (Estimate)

August 22, 2014

Last Update Submitted That Met QC Criteria

August 8, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000543389
  • RPCI-I-68005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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