END-1: First Line Chemotherapy for Advanced or Recurrent Endometrial Carcinoma With Carboplatin and Liposomal Doxorubicin

National Cancer Institute, Naples

Status and phase

Completed

Phase 2

Conditions

Endometrial Cancer

Treatments

Drug: carboplatin

Drug: liposomal doxorubicin

Study type

Interventional

Funder types

Other

Identifiers

NCT00401635

END-1

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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