Brief Title
END-1: First Line Chemotherapy for Advanced or Recurrent Endometrial Carcinoma With Carboplatin and Liposomal Doxorubicin
Official Title
Phase II Multicentered Study of First-Line Chemotherapy for Advanced or Recurrent Endometrial Carcinoma With the Combination of Carboplatin and Liposomal Doxorubicin
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Objective response rate (complete and partial responses)
Condition
Endometrial Cancer
Intervention
liposomal doxorubicin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
42
Start Date
November 2002
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
Gender
Female
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Sandro Pignata, M.D., Ph.D, ,
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT00401635
Organization ID
END-1
Study Sponsor
National Cancer Institute, Naples
Study Sponsor
Sandro Pignata, M.D., Ph.D, Principal Investigator, National Cancer Institute, Naples
Verification Date
September 2007