Endometrial Cancer
Conditions
Keywords
advanced, recurrent, chemotherapy, first-line
Brief summary
The purpose of this study is to evaluate activity and toxicity of the combination of carboplatin and liposomal doxorubicin as first-line chemotherapy of patients with advanced or recurrent endometrial carcinoma.
Detailed description
Treatment is planned with carboplatin AUC 5 given IV on day 1 and liposomal doxorubicin 40 mg/m2 given IV on day 1, with treatment repeated every 28 days. Delays in treatment administration and dose reductions have been planned according to toxicity.
Interventions
DRUGliposomal doxorubicin
DRUGcarboplatin
Sponsors
National Cancer Institute, Naples
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Cytologic / histologic diagnosis of endometrial carcinoma * Indication for chemotherapy * Age 75 years or less * Life expectancy of at least 3 months * Measurable disease \> 1 cm
Exclusion criteria
* Previous or concomitant malignant neoplasia (not including basocellular or spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided they are being adequately treated) * Performance status (ECOG) \> 2 * Previous chemotherapy treatment * Heart disease (heart failure, myocardial heart attack within 6 months prior to randomization, atrioventricular block of any degree, serious arrhythmia) * Leukocytes \< 4000/mm3, platelets \< 100000/mm3 * Impaired renal function (creatinine \> o = 1.25 times the upper normal limit) or liver function (SGOT or SGPT \> o = 1.25 times the upper normal limit) * Present or suspected hemorrhagic syndromes * Uncooperative and/or unreliable patients * Patient's inability to access the center * Refusal of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (complete and partial responses) | — |
| Toxicity | — |
Countries
Italy
Outcome results
None listed