Clinical Trial: Liposome-Encapsulated Doxorubicin Citrate and Carboplatin in Treating Patients With Advanced or Metastatic Recurrent Endometrial Cancer
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
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
Brief 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 Summary:
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.
Sponsor: Medical University Innsbruck
Current Primary Outcome: Response rate
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Duration of progression-free survival
- Overall survival
- Safety
- Feasibility
Original Secondary Outcome: Same as current
Information By: National Cancer Institute (NCI)
Dates:
Date Received: April 7, 2010
Date Started: November 2007
Date Completion:
Last Updated: August 6, 2013
Last Verified: February 2011