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

Sponsor:	European Organization for Research and Treatment of Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00052312

Purpose

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.

Condition	Intervention	Phase
Endometrial Cancer	Drug: cisplatin Drug: doxorubicin hydrochloride Drug: paclitaxel	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Cisplatin Doxorubicin Doxorubicin hydrochloride Paclitaxel Myocet

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Progression-free survival as measured by Kaplan Meier and RECIST at 18 months [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Designated as safety issue: No ]
Toxicity as measured by NCIC Common Toxicity Criteria v2.0 after each course [ Designated as safety issue: Yes ]

Estimated Enrollment:	312
Study Start Date:	September 2002

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00052312

Hide Study Locations

Locations

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

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer

Investigators

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

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000258154, EORTC-55984
Study First Received:	January 24, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00052312 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent endometrial carcinoma
stage III endometrial carcinoma
stage IV endometrial carcinoma
endometrial papillary carcinoma

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Antimitotic Agents
Antibiotics, Antineoplastic
Pharmacologic Actions
Doxorubicin

Genital Diseases, Female
Endometrial Neoplasms
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Cisplatin
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Uterine Neoplasms
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 22, 2009