Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer
NCT ID: NCT00052312
Last Updated: 2012-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
141 participants
INTERVENTIONAL
2002-09-30
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
NONE
Interventions
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cisplatin
doxorubicin hydrochloride
paclitaxel
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Nicholas S. Reed, MD
Role: STUDY_CHAIR
University of Glasgow
Giorgio Bolis, MD
Role: STUDY_CHAIR
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Locations
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Allgemeines Krankenhaus - Universitatskliniken
Vienna, , Austria
Ziekenhuis Netwerk Antwerpen Middelheim
Antwerp, , Belgium
Institut Jules Bordet
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Cazk Groeninghe - Campus Maria's Voorzienigheid
Kortrijk, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Algemeen Ziekenhuis Sint-Augustinus
Wilrijk, , Belgium
Centre Regional Francois Baclesse
Caen, , France
Centre Leon Berard
Lyon, , France
Centro di Riferimento Oncologico - Aviano
Aviano, , Italy
I.R.C.C.S. Policlinico San Matteo
Pavia, , Italy
Azienda Sanitaria Ospedaliera Ordine Mauriziano
Turin, , Italy
Clinica Universitaria
Turin, , Italy
Ospedale Civile
Voghera, , Italy
Onze Lieve Vrouwe Gasthuis
Amsterdam, , Netherlands
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Universitair Medisch Centrum St. Radboud - Nijmegen
Nijmegen, , Netherlands
University Medical Center Utrecht
Utrecht, , Netherlands
Hospitais da Universidade de Coimbra (HUC)
Coimbra, , Portugal
Hospital Universitario San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Instituto Valenciano De Oncologia
Valencia, , Spain
Royal United Hospital
Bath, England, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom
James Cook University Hospital
Middlesbrough, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom
Oldchurch Hospital
Romford, England, United Kingdom
Centre for Cancer Research and Cell Biology at Belfast City Hospital
Belfast, Northern Ireland, United Kingdom
Western Infirmary
Glasgow, Scotland, United Kingdom
Countries
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Other Identifiers
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EORTC-55984
Identifier Type: -
Identifier Source: secondary_id
EORTC-55984
Identifier Type: -
Identifier Source: org_study_id