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

This study has been terminated.
(Due to low accrual)
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00470067
First received: May 3, 2007
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Endometrial Cancer
Drug: carboplatin
Drug: pegylated liposomal doxorubicin hydrochloride
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center Phase II Study of Doxil®/Carboplatin in Patients With Advanced or Recurrent Endometrial Carcinoma

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Response (Complete and Partial) [ Time Frame: Every 28 days ] [ Designated as safety issue: No ]
    Response Rate


Enrollment: 9
Study Start Date: February 2007
Study Completion Date: December 2009
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00470067

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Shashikant B. Lele, MD Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00470067     History of Changes
Other Study ID Numbers: CDR0000543389, RPCI-I-68005
Study First Received: May 3, 2007
Results First Received: January 27, 2014
Last Updated: August 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
recurrent endometrial carcinoma
stage III endometrial carcinoma
stage IV endometrial carcinoma

Additional relevant MeSH terms:
Liposomal doxorubicin
Carboplatin
Doxorubicin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014