NCT01100359

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Medical University Innsbruck · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	carboplatin
DRUG	liposome-encapsulated doxorubicin citrate
OTHER	laboratory biomarker analysis
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2007-11-01
• Primary completion: 2010-10-01
• First posted: 2010-04-08
• Last updated: 2013-08-07

Locations

1 site across 1 country: Austria