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

Phase 2

• Conditions: Endometrial Cancer

• Registration Number: NCT01100359
• Lead Sponsor: Medical University Innsbruck

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 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.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2010-04-07
• Study First Submitted QC: 2010-04-07
• Study First Posted: 2010-04-08
• Primary Completion: 2010-10
• Status Verified: 2011-02
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate

Secondary Outcome Measures

Name	Time	Method
Feasibility
Duration of progression-free survival
Overall survival
Safety

Trial Locations

Locations (1)

Innsbruck Universitaetsklinik; 🇦🇹 Innsbruck, Austria