Back to results

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

Primary Purpose

Endometrial Cancer

Status

Unknown status

Phase

Phase 2

Locations

Austria

Study Type

Interventional

Intervention

carboplatin

liposome-encapsulated doxorubicin citrate

laboratory biomarker analysis

quality-of-life assessment

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring endometrial clear cell carcinoma, recurrent endometrial carcinoma, stage IIIA endometrial carcinoma, stage IIIB endometrial carcinoma, stage IIIC endometrial carcinoma, stage IVA endometrial carcinoma, stage IVB endometrial carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Innsbruck UniversitaetsklinikRecruiting

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Duration of progression-free survival

Overall survival

Safety

Feasibility

Full Information

NCT ID

NCT01100359

First Posted

April 7, 2010

Last Updated

August 6, 2013

Sponsor

Medical University Innsbruck

1. Study Identification

Unique Protocol Identification Number

NCT01100359

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

February 2011

Overall Recruitment Status

Unknown status

Study Start Date

November 2007 (undefined)

Primary Completion Date

October 2010 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Medical University Innsbruck

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometrial Cancer

Keywords

endometrial clear cell carcinoma, recurrent endometrial carcinoma, stage IIIA endometrial carcinoma, stage IIIB endometrial carcinoma, stage IIIC endometrial carcinoma, stage IVA endometrial carcinoma, stage IVB endometrial carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

None (Open Label)

Enrollment

39 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

carboplatin

Intervention Type

Drug

Intervention Name(s)

liposome-encapsulated doxorubicin citrate

Intervention Type

Other

Intervention Name(s)

laboratory biomarker analysis

Intervention Type

Procedure

Intervention Name(s)

quality-of-life assessment

Primary Outcome Measure Information:

Title

Response rate

Secondary Outcome Measure Information:

Title

Duration of progression-free survival

Title

Overall survival

Title

Safety

Title

Feasibility

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian Marth, MD, PhD

Organizational Affiliation

Medical University Innsbruck

Official's Role

Study Chair

Facility Information:

Facility Name

Innsbruck Universitaetsklinik

City

Innsbruck

ZIP/Postal Code

A-6020

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Contact Person

Phone

43-512-504-23050

Christian.marth@i-med.ac.at

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs