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

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ClinicalTrials.gov Identifier: NCT00470067
Recruitment Status : Terminated (Due to low accrual)
First Posted : May 7, 2007
Results First Posted : August 22, 2014
Last Update Posted : August 22, 2014
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Endometrial Cancer Drug: carboplatin Drug: pegylated liposomal doxorubicin hydrochloride Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center Phase II Study of Doxil®/Carboplatin in Patients With Advanced or Recurrent Endometrial Carcinoma
Study Start Date : February 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Response (Complete and Partial) [ Time Frame: Every 28 days ]
    Response Rate


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00470067


Locations
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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
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Principal Investigator: Shashikant B. Lele, MD Roswell Park Cancer Institute
More Information
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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00470067    
Other Study ID Numbers: CDR0000543389
RPCI-I-68005
First Posted: May 7, 2007    Key Record Dates
Results First Posted: August 22, 2014
Last Update Posted: August 22, 2014
Last Verified: August 2014
Keywords provided by Roswell Park Cancer Institute:
recurrent endometrial carcinoma
stage III endometrial carcinoma
stage IV endometrial carcinoma
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Carboplatin
 Doxorubicin
Liposomal doxorubicin
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action