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

Phase 2

Completed

• Conditions: Endometrial Cancer

• Registration Number: NCT00401635
• Lead Sponsor: National Cancer Institute, Naples

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.

Study Timeline

• Study Start: 2002-11
• Study First Submitted: 2006-11-17
• Study First Submitted QC: 2006-11-17
• Study First Posted: 2006-11-20
• Status Verified: 2007-09
• Last Update Submitted: 2007-09-04
• Last Update Posted: 2007-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Objective response rate (complete and partial responses)
Toxicity

Trial Locations

Locations (4)

Ospedale Fatebenefratelli, U.O. di Oncologia; 🇮🇹 Benevento, BN, Italy

Ospedale Pierantoni, Divisione di Oncologia Medica; 🇮🇹 Forli', FO, Italy

Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B; 🇮🇹 Napoli, Italy

Ospedale S. Giovanni Calibita Fatebenefratelli; 🇮🇹 Roma, Italy