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

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401635
• Other study ID #: END-1
• Status: Completed
• Phase: Phase 2
• First received: November 17, 2006
• Last updated: September 4, 2007
• Start date: November 2002

Study information

• Verified date: September 2007
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Drug:
• liposomal doxorubicin

• carboplatin

Locations

Country	Name	City	State
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Pignata S, Scambia G, Pisano C, Breda E, Di Maio M, Greggi S, Ferrandina G, Lorusso D, Zagonel V, Febbraro A, Riva N, De Rosa V, Gallo C, Perrone F; Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies Group. A multicentre phase II st — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (complete and partial responses)
Primary	Toxicity