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

Primary Purpose

Endometrial Cancer

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
liposomal doxorubicin
carboplatin
Sponsored by
National Cancer Institute, Naples
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring advanced, recurrent, chemotherapy, first-line

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Ospedale Fatebenefratelli, U.O. di Oncologia
  • Ospedale Pierantoni, Divisione di Oncologia Medica
  • Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
  • Ospedale S. Giovanni Calibita Fatebenefratelli

Outcomes

Primary Outcome Measures

Objective response rate (complete and partial responses)
Toxicity

Secondary Outcome Measures

Full Information

First Posted
November 17, 2006
Last Updated
September 4, 2007
Sponsor
National Cancer Institute, Naples
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1. Study Identification

Unique Protocol Identification Number
NCT00401635
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute, Naples

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
advanced, recurrent, chemotherapy, first-line

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
liposomal doxorubicin
Intervention Type
Drug
Intervention Name(s)
carboplatin
Primary Outcome Measure Information:
Title
Objective response rate (complete and partial responses)
Title
Toxicity

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandro Pignata, M.D., Ph.D
Organizational Affiliation
National Cancer Institute, Naples
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francesco Perrone, M.D., Ph.D
Organizational Affiliation
National Cancer Institute, Naples
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Fatebenefratelli, U.O. di Oncologia
City
Benevento
State/Province
BN
ZIP/Postal Code
82100
Country
Italy
Facility Name
Ospedale Pierantoni, Divisione di Oncologia Medica
City
Forli'
State/Province
FO
ZIP/Postal Code
47100
Country
Italy
Facility Name
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale S. Giovanni Calibita Fatebenefratelli
City
Roma
ZIP/Postal Code
00186
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
17486128
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.
Results Reference
result

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

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