Clinical trial NCT00401635: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometrial Cancer
Keywords: advanced
recurrent
chemotherapy
first-line
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2006-11-20
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Objective response rate (complete and partial responses)
measure: Toxicity
Secondary outcomes:
Other outcomes:
Locations:
city: Benevento
country: Italy
facility: Ospedale Fatebenefratelli, U.O. di Oncologia
state: BN
city: Forli'
country: Italy
facility: Ospedale Pierantoni, Divisione di Oncologia Medica
state: FO
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
city: Roma
country: Italy
facility: Ospedale S. Giovanni Calibita Fatebenefratelli
Study officials:
affiliation: National Cancer Institute, Naples
name: Sandro Pignata, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Francesco Perrone, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 study of carboplatin plus pegylated liposomal doxorubicin as first-line chemotherapy for patients with advanced or recurrent endometrial carcinoma: the END-1 study of the MITO (Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies) group. Br J Cancer. 2007 Jun 4;96(11):1639-43. doi: 10.1038/sj.bjc.6603787. Epub 2007 May 8.