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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute, Naples
• Treatments: Carboplatin; Doxorubicin; Liposomal doxorubicin

Criteria

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