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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

Phase 2
18 Years
Open (Enrolling)
Endometrial Cancer

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Trial Information

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



- To assess activity of the combination of liposome-encapsulated doxorubicin citrate and
carboplatin in patients with primary advanced or metastatic recurrent carcinoma of the


- 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.

Inclusion Criteria


- 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


- 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

- No known hypersensitivity to study drugs

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


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Safety Issue:


Principal Investigator

Christian Marth, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Medical University Innsbruck



Study ID:




Start Date:

November 2007

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • endometrial clear cell carcinoma
  • recurrent endometrial carcinoma
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma