NCT01100359

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Last Updated

August 7, 2013

Status Verified

February 1, 2011

Enrollment Period

2.9 years

First QC Date

April 7, 2010

Last Update Submit

August 6, 2013

Conditions

Endometrial Cancer

Keywords

endometrial clear cell carcinomarecurrent endometrial carcinomastage IIIA endometrial carcinomastage IIIB endometrial carcinomastage IIIC endometrial carcinomastage IVA endometrial carcinomastage IVB endometrial carcinoma

Outcome Measures

Primary Outcomes (1)

  • Response rate

Secondary Outcomes (4)

  • Duration of progression-free survival

  • Overall survival

  • Safety

  • Feasibility

Interventions

carboplatinDRUG
liposome-encapsulated doxorubicin citrateDRUG
laboratory biomarker analysisOTHER
quality-of-life assessmentPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Innsbruck Universitaetsklinik

Innsbruck, A-6020, Austria

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • Christian Marth, MD, PhD

    Medical University Innsbruck

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2010

First Posted

April 8, 2010

Study Start

November 1, 2007

Primary Completion

October 1, 2010

Last Updated

August 7, 2013

Record last verified: 2011-02

Locations

AU(1)