Phase II Multicentered Study of First-Line Chemotherapy for Advanced or Recurrent Endometrial Carcinoma With the Combination of Carboplatin and Liposomal Doxorubicin

National Cancer Institute, Naples4 sites in 1 country42 target enrollmentNovember 2002

ConditionsEndometrial Cancer

Drugsliposomal doxorubicin carboplatin

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Endometrial Cancer
Sponsor: National Cancer Institute, Naples
Enrollment: 42
Locations: 4
Primary Endpoint: Objective response rate (complete and partial responses)
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2002

End Date

TBD

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

National Cancer Institute, Naples

Eligibility 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