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

Endometrial Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01100359
• Other study ID #: MUI-AGO-15
• Secondary ID: CDR0000669712EUD
• Status: Recruiting
• Phase: Phase 2
• First received: April 7, 2010
• Last updated: August 6, 2013
• Start date: November 2007

Study information

• Verified date: February 2011
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of endometrial carcinoma, including any of the following cellular types:

• Mixed Mullerian carcinoma

• Serous carcinoma

• Clear cell carcinoma

• Primary advanced (FIGO stage III or stage IV) or metastatic recurrent disease

• Disease not curable by surgery

• Measurable disease, defined as = 1 unidimensionally measurable lesion = 20 mm with x-ray, physical exam, or non-spiral CT scan OR = 10 mm with spiral CT scan or MRI

• No known cerebral metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy = 12 weeks

• Platelet count = 100,000/mm^3

• ANC = 1,500/mm^3

• Hemoglobin = 10 g/dL

• Creatinine = 1.25 times upper limit of normal (ULN)

• Bilirubin = 1.25 times ULN

• AST/ALT < 3 times ULN

• Glomerular filtration rate = 50 mL/min

• LVEF = 50% by ECHO

• Fertile patients must use effective contraception

• No myocardial infarction within the past 6 months

• No NYHA class II-IV congestive heart failure

• No third degree or complete heart block unless a pacemaker is in place

• No other malignancy within the past 5 years

• No concomitant medical illness (e.g., uncontrolled infection, uncontrolled angina, or other relevant illness) that makes the prescribed treatments within this study unfeasible

• No known hypersensitivity to study drugs

• No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy for disease recurrence

• At least 12 months since prior adjuvant therapy containing anthracyclines with cumulative doses not exceeding the following:

• Epirubicin 600 mg/m²

• Doxorubicin 300 mg/m²

• At least 6 months since prior adjuvant therapy containing platinum

• At least 4 weeks since completion of radiotherapy involving the whole pelvis

• No concurrent radiotherapy or planned radiotherapy after study

• No concurrent endocrine, immunological, or other anticancer therapy

• No concurrent participation in another investigational drug study

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Drug:
• carboplatin

• liposome-encapsulated doxorubicin citrate

Other:
• laboratory biomarker analysis

Procedure:
• quality-of-life assessment

Locations

Country	Name	City	State
Austria	Innsbruck Universitaetsklinik	Innsbruck

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate			No
Secondary	Duration of progression-free survival			No
Secondary	Overall survival			No
Secondary	Safety			Yes
Secondary	Feasibility			No