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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Drug: carboplatin
* Drug: pegylated liposomal doxorubicin hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma