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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT00401635
First received: November 17, 2006
Last updated: September 4, 2007
Last verified: September 2007
  Purpose

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 Intervention Phase
Endometrial Cancer
Drug: liposomal doxorubicin
Drug: carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:
  • Objective response rate (complete and partial responses)
  • Toxicity

Estimated Enrollment: 42
Study Start Date: November 2002
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401635

Locations
Italy
Ospedale Fatebenefratelli, U.O. di Oncologia
Benevento, BN, Italy, 82100
Ospedale Pierantoni, Divisione di Oncologia Medica
Forli', FO, Italy, 47100
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
Napoli, Italy, 80131
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00401635     History of Changes
Other Study ID Numbers: END-1
Study First Received: November 17, 2006
Last Updated: September 4, 2007
Health Authority: Italy: Ethics Committee

Keywords provided by National Cancer Institute, Naples:
advanced
recurrent
chemotherapy
first-line

Additional relevant MeSH terms:
Carcinoma
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Doxorubicin
Liposomal doxorubicin
Carboplatin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014