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

NCT ID: NCT00470067

Last Updated: 2014-08-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2009-12-31

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.

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.

Conditions

Endometrial Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Doxorubicin and carboplatin

Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1

Group Type: EXPERIMENTAL

carboplatin

Intervention Type: DRUG

IV

pegylated liposomal doxorubicin hydrochloride

Intervention Type: DRUG

IV

Interventions

carboplatin

IV

Intervention Type: DRUG

pegylated liposomal doxorubicin hydrochloride

IV

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shashikant B. Lele, MD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

RPCI-I-68005

Identifier Type: -

Identifier Source: secondary_id

CDR0000543389

Identifier Type: -

Identifier Source: org_study_id