Liposome-Encapsulated Doxorubicin Citrate and Carboplatin in Treating Patients With Advanced or Metastatic Recurrent Endometrial Cancer
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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.email@example.com|
|Study Chair:||Christian Marth, MD, PhD||Medical University Innsbruck|