Clinical trial · Interventional
Doxorubicin Hydrochloride Liposome and Carboplatin in Treating Patients With Recurrent, Stage III, or Stage IV Primary Endometrial Cancer
A Multi-center Phase II Study of Doxil®/Carboplatin in Patients With Advanced or Recurrent Endometrial Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to low accrual
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving doxorubicin hydrochloride liposome together with carboplatin works in treating patients with recurrent, stage III, or stage IV primary 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| pegylated liposomal doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Doxorubicin and carboplatin
- description
- Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1
- interventionNames
- Drug: carboplatin
- Drug: pegylated liposomal doxorubicin hydrochloride
Primary outcomes (1)
- measure
- Response (Complete and Partial)
- timeFrame
- Every 28 days
- description
- Response Rate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed primary endometrial carcinoma meeting 1 of the following criteria: * Stage III or IV disease according to FIGO staging criteria * Recurrent disease that is considered incurable * Measurable disease * A lesion within a previously irradiated field is acceptable as measurable disease only if there has been clear progression since completion of radiotherapy PATIENT CHARACTERISTICS: * GOG performance status 0-2 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9 g/dL * Creatinine \< 2.5 mg/dL OR creatinine clearance ≥ 60 mL/min * ALT and AST ≤ 1.5 times upper limit of normal (ULN) (3 times ULN in the presence of liver metastases) * Alkaline phosphatase ≤ 1.5 times ULN (3 times ULN in the presence of liver metastases) * Total bilirubin ≤ 1.5 times ULN (3 times ULN in the presence of liver metastases) * Not pregnant or nursing * Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA scan or ECHO * No history of severe hypersensitivity reaction to doxorubicin hydrochloride liposome * No other invasive malignancy (i.e., breast cancer) within the past 5 years except nonmelanoma skin cancer * No cardiac disease, including any of the following: * Myocardial infarction within the past 6 months * NYHA class II-IV heart failure * Uncontrolled angina * Severe uncontrolled ventricular arrhythmias * Clinically significant pericardial disease * Acute ischemic or active conduction system abnormalities by ECHO PRIOR CONCURRENT THERAPY: * No prior chemotherapy * No prior cancer therapy that would contraindicate study treatment * No concurrent investigational agents
References
Publications (0)
Data not yet available