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

Sponsor

National Cancer Institute, Naples (Other)

Overall Status

Completed

CT.gov ID

NCT00401635

Collaborator

(none)

Enrollment

Locations

10.5

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Cancer	Drug: liposomal doxorubicin Drug: carboplatin	Phase 2

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2002

Outcome Measures

Primary Outcome Measures

Objective response rate (complete and partial responses) []
Toxicity []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale Fatebenefratelli, U.O. di Oncologia	Benevento	BN	Italy	82100
2	Ospedale Pierantoni, Divisione di Oncologia Medica	Forli'	FO	Italy	47100
3	Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B	Napoli		Italy	80131
4	Ospedale S. Giovanni Calibita Fatebenefratelli	Roma		Italy	00186

Sponsors and Collaborators

National Cancer Institute, Naples

Investigators

Principal Investigator: Sandro Pignata, M.D., Ph.D, National Cancer Institute, Naples
Principal Investigator: Francesco Perrone, M.D., Ph.D, National Cancer Institute, Naples