Liposome-Encapsulated Doxorubicin Citrate and Carboplatin in Treating Patients With Advanced or Metastatic Recurrent Endometrial Cancer
|ClinicalTrials.gov Identifier: NCT01100359|
Recruitment Status : Unknown
Verified February 2011 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : April 8, 2010
Last Update Posted : August 7, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Drug: carboplatin Drug: liposome-encapsulated doxorubicin citrate Other: laboratory biomarker analysis Procedure: quality-of-life assessment||Phase 2|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2007|
|Estimated Primary Completion Date :||October 2010|
- Response rate
- Duration of progression-free survival
- Overall survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01100359
|Innsbruck, Austria, A-6020|
|Contact: Contact Person 43-512-504-23050 Christian.firstname.lastname@example.org|
|Study Chair:||Christian Marth, MD, PhD||Medical University Innsbruck|