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

NCT ID: NCT01100359

Last Updated: 2013-08-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30

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.

Conditions

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

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

carboplatin

Intervention Type: DRUG

liposome-encapsulated doxorubicin citrate

Intervention Type: DRUG

laboratory biomarker analysis

Intervention Type: OTHER

quality-of-life assessment

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University Innsbruck

OTHER

Sponsor Role: lead

Principal Investigators

Christian Marth, MD, PhD

Role: STUDY_CHAIR

Medical University Innsbruck

Locations

Innsbruck Universitaetsklinik

Innsbruck, , Austria

Site Status: RECRUITING

Countries

Austria

Facility Contacts

Contact Person

Role: primary

Other Identifiers

CDR0000669712

Identifier Type: REGISTRY

Identifier Source: secondary_id

EUDRACT-2007-004060-40

Identifier Type: -

Identifier Source: secondary_id

EU-21027

Identifier Type: -

Identifier Source: secondary_id

MUI-AGO-15

Identifier Type: -

Identifier Source: org_study_id