Liposome-Encapsulated Doxorubicin Citrate and Carboplatin in Treating Patients With Advanced or Metastatic Recurrent Endometrial Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as liposome-encapsulated doxorubicin citrate and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well liposome-encapsulated doxorubicin citrate given together with carboplatin works in treating patients with advanced or metastatic recurrent endometrial cancer.

Detailed Description
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OBJECTIVES: Primary To assess activity of the combination of liposome-encapsulated doxorubicin citrate and carboplatin in patients with primary advanced or metastatic recurrent carcinoma of the endometrium. Secondary To assess the toxicity and feasibility of this regimen in these patients. To determine the progression-free survival and overall survival of these patients. OUTLINE: This is a multicenter study. Patients receive liposome-encapsulated doxorubicin citrate IV over 1 hour followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6-9 courses in the absence of disease progression or unacceptable toxicity. Tissue array and immunohistochemistry analysis are conducted on paraffin-embedded tumor blocks of the primarily operated tissue of all patients for different markers (e.g., progesterone-/estrogen receptor, HER2-receptor, soluble L1-molecule, Topo 2a) to examine tumor characteristics. Quality of life is assessed at baseline, during study treatment, at completion of study treatment, and then at 1 year after completion of study treatment. After completion of study therapy, patients are followed up every 3 months for 1 year.

Official Title
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Phase II Multicenter Trial of the Austrian AGO With the Combination of Liposomal Doxorubicin (Myocet®) and Carboplatin in Primary Advanced or Metastatic and Recurrent Endometrial Cancer

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Drug: carboplatin
* Drug: liposome-encapsulated doxorubicin citrate
* Other: laboratory biomarker analysis
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of endometrial carcinoma, including any of the following cellular types: Mixed Mullerian carcinoma Serous carcinoma Clear cell carcinoma Primary advanced (FIGO stage III or stage IV) or metastatic recurrent disease Disease not curable by surgery Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm with x-ray, physical exam, or non-spiral CT scan OR ≥ 10 mm with spiral CT scan or MRI No known cerebral metastases PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy ≥ 12 weeks Platelet count ≥ 100,000/mm^3 ANC ≥ 1,500/mm^3 Hemoglobin ≥ 10 g/dL Creatinine ≤ 1.25 times upper limit of normal (ULN) Bilirubin ≤ 1.25 times ULN AST/ALT < 3 times ULN Glomerular filtration rate ≥ 50 mL/min LVEF ≥ 50% by ECHO Fertile patients must use effective contraception No myocardial infarction within the past 6 months No NYHA class II-IV congestive heart failure No third degree or complete heart block unless a pacemaker is in place No other malignancy within the past 5 years No concomitant medical illness (e.g., uncontrolled infection, uncontrolled angina, or other relevant illness) that makes the prescribed treatments within this study unfeasible No known hypersensitivity to study drugs No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule PRIOR CONCURRENT THERAPY: No prior chemotherapy for disease recurrence At least 12 months since prior adjuvant therapy containing anthracyclines with cumulative doses not exceeding the following: Epirubicin 600 mg/m² Doxorubicin 300 mg/m² At least 6 months since prior adjuvant therapy containing platinum At least 4 weeks since completion of radiotherapy involving the whole pelvis No concurrent radiotherapy or planned radiotherapy after study No concurrent endocrine, immunological, or other anticancer therapy No concurrent participation in another investigational drug study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: carboplatin|nan|
|Drug: liposome-encapsulated doxorubicin citrate|nan|
|Other: laboratory biomarker analysis|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of progression-free survival |  |  | 
| Overall survival |  |  | 
| Safety |  |  | 
| Feasibility |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometrial clear cell carcinoma, recurrent endometrial carcinoma, stage IIIA endometrial carcinoma, stage IIIB endometrial carcinoma, stage IIIC endometrial carcinoma, stage IVA endometrial carcinoma, stage IVB endometrial carcinoma