Status:
COMPLETED
END-1: First Line Chemotherapy for Advanced or Recurrent Endometrial Carcinoma With Carboplatin and Liposomal Doxorubicin
Lead Sponsor:
National Cancer Institute, Naples
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
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...
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00401635
Start Date
November 1 2002
Last Update
September 5 2007
Active Locations (4)
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1
Ospedale Fatebenefratelli, U.O. di Oncologia
Benevento, BN, Italy, 82100
2
Ospedale Pierantoni, Divisione di Oncologia Medica
Forlì, FO, Italy, 47100
3
Ospedale S. Giovanni Calibita Fatebenefratelli
Roma, Roma, Italy, 00186
4
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
Napoli, Italy, 80131