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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01100359
First received: April 7, 2010
Last updated: August 6, 2013
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Endometrial Cancer
Drug: carboplatin
Drug: liposome-encapsulated doxorubicin citrate
Other: laboratory biomarker analysis
Procedure: quality-of-life assessment
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]
  • Feasibility [ Designated as safety issue: No ]

Estimated Enrollment: 39
Study Start Date: November 2007
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100359

Locations
Austria
Innsbruck Universitaetsklinik Recruiting
Innsbruck, Austria, A-6020
Contact: Contact Person    43-512-504-23050    Christian.marth@i-med.ac.at   
Sponsors and Collaborators
Medical University Innsbruck
Investigators
Study Chair: Christian Marth, MD, PhD Medical University Innsbruck
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01100359     History of Changes
Other Study ID Numbers: MUI-AGO-15, CDR0000669712, EUDRACT-2007-004060-40, EU-21027
Study First Received: April 7, 2010
Last Updated: August 6, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Liposomal doxorubicin
Carboplatin
Doxorubicin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014