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

Roswell Park Comprehensive Cancer Center

Status and phase

Terminated

Phase 2

Conditions

Endometrial Cancer

Treatments

Drug: pegylated liposomal doxorubicin hydrochloride

Drug: carboplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00470067

RPCI-I-68005

CDR0000543389

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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