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


Phase 2
18 Years
75 Years
Not Enrolling
Female
Endometrial Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective response rate (complete and partial responses)

Principal Investigator

Sandro Pignata, M.D., Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute, Naples

Authority:

Italy: Ethics Committee

Study ID:

END-1

NCT ID:

NCT00401635

Start Date:

November 2002

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • advanced
  • recurrent
  • chemotherapy
  • first-line
  • Carcinoma
  • Endometrial Neoplasms
  • Adenoma

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