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Endometrial CancerPhase 2NCT01100359

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

A Phase 2 study testing carboplatin, liposome-encapsulated doxorubicin citrate and laboratory biomarker analysis in people with Endometrial Cancer, run by Medical University Innsbruck at 1 site in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Endometrial Cancer
What is being tested?
carboplatin, liposome-encapsulated doxorubicin citrate and laboratory biomarker analysis
Type of treatment
Surgery or procedure
How many people
39 participants
Where
1 siteAustria
Study dates
Nov 2007to Oct 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

Austria1 site, 1 recruiting

  • Innsbruck Universitaetsklinik

    Innsbruck, A-6020

    Contact Person, 43-512-504-23050, Christian.marth@i-med.ac.at

    Recruiting

Other trials in Austria

About this study

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

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.

Read the 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.

Being tested
carboplatin, liposome-encapsulated doxorubicin citrate, laboratory biomarker analysis, quality-of-life assessment
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
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • carboplatinDrug

  • liposome-encapsulated doxorubicin citrateDrug

  • laboratory biomarker analysisOther

  • quality-of-life assessmentProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate

Secondary outcomes (4)

  1. Duration of progression-free survival

  2. Overall survival

  3. Safety

  4. Feasibility

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2010 (estimated)
  2. Study startNov 2007
  3. Primary completionOct 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01100359
Sponsor's protocol ID
MUI-AGO-15
Other IDs
CDR0000669712, EUDRACT-2007-004060-40, EU-21027
Status last verified
Feb 2011
First submitted
7 Apr 2010
Last updated
7 Aug 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carboplatin, liposome-encapsulated doxorubicin citrate and laboratory biomarker analysis in people with Endometrial Cancer, run by Medical University Innsbruck at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01100359.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.

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