Endometrial Cancer Clinical Trial
Official title:
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
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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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