Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer

September 20, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Randomized Trial Of Adriamycin (A) Cisplatin (P) Chemotherapy Versus Paclitaxel (T) Adriamycin (A) And Cisplatin (P) In Patients With Metastatic/Relapsed Or Locally Advanced Inoperable Endometrial Cancer

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether doxorubicin and cisplatin are more effective with or without paclitaxel in treating endometrial cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of combining doxorubicin and cisplatin with or without paclitaxel in treating patients who have locally advanced, metastatic, and/or relapsed endometrial cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the overall survival of patients with locally advanced, metastatic, and/or relapsed endometrial cancer treated with doxorubicin and cisplatin with or without paclitaxel.
  • Compare the toxicity of these regimens in these patients.
  • Compare the progression-free survival at 18 months of patients treated with these regimens.
  • Compare quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to performance status (0 vs 1 vs 2), metastatic disease (M0 vs M1), prior pelvic radiotherapy for pelvic recurrence (yes vs no), and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive doxorubicin IV over 30 minutes, paclitaxel IV over 3 hours, and cisplatin IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive doxorubicin and cisplatin as in arm I. Quality of life is assessed at baseline, before each course, after courses 3 and 6, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. In the event of progressive disease, quality of life is assessed every 3 months.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. In the event of progressive disease, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

141

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A-1090
        • Allgemeines Krankenhaus - Universitatskliniken
  • Belgium
      • Antwerp, Belgium, 2020
        • Ziekenhuis Netwerk Antwerpen Middelheim
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Edegem, Belgium, B-2650
        • Universitair Ziekenhuis Antwerpen
      • Kortrijk, Belgium, B-8500
        • Cazk Groeninghe - Campus Maria's Voorzienigheid
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
      • Wilrijk, Belgium, 2610
        • Algemeen Ziekenhuis Sint-Augustinus
  • France
      • Caen, France, 14076
        • Centre Regional Francois Baclesse
      • Lyon, France, 69373
        • Centre Leon Bérard
  • Italy
      • Aviano, Italy, 33081
        • Centro di Riferimento Oncologico - Aviano
      • Pavia, Italy, 27100
        • I.R.C.C.S. Policlinico San Matteo
      • Turin, Italy, 10128
        • Azienda Sanitaria Ospedaliera Ordine Mauriziano
      • Turin, Italy, 10138
        • Clinica Universitaria
      • Voghera, Italy, 27058
        • Ospedale Civile
  • Netherlands
      • Amsterdam, Netherlands, 1091 HA
        • Onze Lieve Vrouwe Gasthuis
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum at University of Amsterdam
      • Enschede, Netherlands, 7500 KA
        • Medisch Spectrum Twente
      • Leiden, Netherlands, 2300 CA
        • Leiden University Medical Center
      • Nijmegen, Netherlands, 6500 HB
        • Universitair Medisch Centrum St. Radboud - Nijmegen
      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht
  • Portugal
      • Coimbra, Portugal, 3049
        • Hospitais da Universidade de Coimbra (HUC)
  • Spain
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28040
        • Hospital Universitario San Carlos
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncología
  • United Kingdom
    • England
      • Bath, England, United Kingdom, BA1 3NG
        • Royal United Hospital
      • Bristol, England, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology Centre
      • Leeds, England, United Kingdom, LS9 7TF
        • Leeds Cancer Centre at St. James's University Hospital
      • Merseyside, England, United Kingdom, CH63 4JY
        • Clatterbridge Centre for Oncology NHS Trust
      • Middlesbrough, England, United Kingdom, TS4 3BW
        • James Cook University Hospital
      • Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE
        • Northern Centre for Cancer Treatment at Newcastle General Hospital
      • Northwood, England, United Kingdom, HA6 2RN
        • Mount Vernon Cancer Centre at Mount Vernon Hospital
      • Nottingham, England, United Kingdom, NG5 1PB
        • Nottingham City Hospital NHS Trust
      • Romford, England, United Kingdom, RM7 OBE
        • Oldchurch Hospital
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT9 7AB
        • Centre for Cancer Research and Cell Biology at Belfast City Hospital
    • Scotland
      • Glasgow, Scotland, United Kingdom, G11 6NT
        • Western Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed endometrial epithelial carcinoma meeting at least 1 of the following criteria:

    • Advanced metastatic and/or relapsed disease
    • Locally advanced inoperable or unresectable disease
  • No mixed mesodermal tumor and/or tumors showing evidence of sarcomatous elements
  • Uterine papillary serous carcinoma allowed

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Neutrophil count greater than 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin greater than 10 g/dL (transfusions allowed)

Hepatic

  • ALT and AST less than 2 times upper limit of normal (ULN)
  • Alkaline phosphatase less than 2 times ULN
  • Bilirubin less than 1.5 times ULN

Renal

  • Creatinine less than 1.5 times ULN
  • Creatinine clearance greater than 50 mL/min

Cardiovascular

  • Normal baseline EKG
  • Normal baseline LVEF on MUGA or echocardiogram for patients who received prior anthracyclines

Other

  • Able to tolerate high-dose dexamethasone
  • Must be considered fit for chemotherapy
  • No uncontrolled infection
  • No other malignancy within the past 5 years except successfully treated basal cell skin cancer or carcinoma in situ of the cervix
  • No prior nervous or psychiatric disorder that would preclude study compliance
  • No psychological, familial, sociological, or geographic condition that would preclude study participation
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • At least 12 months since prior adjuvant chemotherapy
  • Total dose of prior doxorubicin no greater than 200 mg/m^2
  • Total dose of prior epirubicin no greater than 300 mg/m^2

Endocrine therapy

  • At least 28 days since prior hormonal therapy for patients with partial or complete response after first-line treatment

Radiotherapy

  • No prior radiotherapy to any area other than pelvis
  • No concurrent radiotherapy

Surgery

  • Not specified

Other

  • No other concurrent anticancer medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Progression-free survival as measured by Kaplan Meier and RECIST at 18 months

Secondary Outcome Measures

Outcome Measure
Overall survival as measured by Kaplan Meier after each course, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter
Toxicity as measured by NCIC Common Toxicity Criteria v2.0 after each course

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Nicholas S. Reed, MD, University of Glasgow
  • Study Chair: Giorgio Bolis, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

January 24, 2003

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

September 24, 2012

Last Update Submitted That Met QC Criteria

September 20, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-55984

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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