Clinical trial · Interventional
Liposome-Encapsulated Doxorubicin Citrate and Carboplatin in Treating Patients With Advanced or Metastatic Recurrent Endometrial Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| liposome-encapsulated doxorubicin citrate | Drug | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate
Secondary outcomes (4)
- measure
- Duration of progression-free survival
- measure
- Overall survival
- measure
- Safety
- measure
- Feasibility
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available