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

Primary Purpose

Endometrial Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
cisplatin
doxorubicin hydrochloride
paclitaxel
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring recurrent endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma, endometrial papillary serous carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Allgemeines Krankenhaus - Universitatskliniken
  • Ziekenhuis Netwerk Antwerpen Middelheim
  • Institut Jules Bordet
  • Universitair Ziekenhuis Antwerpen
  • Cazk Groeninghe - Campus Maria's Voorzienigheid
  • U.Z. Gasthuisberg
  • Algemeen Ziekenhuis Sint-Augustinus
  • Centre Regional Francois Baclesse
  • Centre Leon Berard
  • Centro di Riferimento Oncologico - Aviano
  • I.R.C.C.S. Policlinico San Matteo
  • Azienda Sanitaria Ospedaliera Ordine Mauriziano
  • Clinica Universitaria
  • Ospedale Civile
  • Onze Lieve Vrouwe Gasthuis
  • Academisch Medisch Centrum at University of Amsterdam
  • Medisch Spectrum Twente
  • Leiden University Medical Center
  • Universitair Medisch Centrum St. Radboud - Nijmegen
  • University Medical Center Utrecht
  • Hospitais da Universidade de Coimbra (HUC)
  • Hospital Universitario San Carlos
  • Hospital Universitario 12 de Octubre
  • Instituto Valenciano De Oncologia
  • Royal United Hospital
  • Bristol Haematology and Oncology Centre
  • Leeds Cancer Centre at St. James's University Hospital
  • Clatterbridge Centre for Oncology NHS Trust
  • James Cook University Hospital
  • Northern Centre for Cancer Treatment at Newcastle General Hospital
  • Mount Vernon Cancer Centre at Mount Vernon Hospital
  • Nottingham City Hospital NHS Trust
  • Oldchurch Hospital
  • Centre for Cancer Research and Cell Biology at Belfast City Hospital
  • Western Infirmary

Outcomes

Primary Outcome Measures

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

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
Toxicity as measured by NCIC Common Toxicity Criteria v2.0 after each course

Full Information

First Posted
January 24, 2003
Last Updated
September 20, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00052312
Brief Title
Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
recurrent endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma, endometrial papillary serous carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Primary Outcome Measure Information:
Title
Progression-free survival as measured by Kaplan Meier and RECIST at 18 months
Secondary Outcome Measure Information:
Title
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
Title
Toxicity as measured by NCIC Common Toxicity Criteria v2.0 after each course

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas S. Reed, MD
Organizational Affiliation
University of Glasgow
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Giorgio Bolis, MD
Organizational Affiliation
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Official's Role
Study Chair
Facility Information:
Facility Name
Allgemeines Krankenhaus - Universitatskliniken
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Ziekenhuis Netwerk Antwerpen Middelheim
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
Cazk Groeninghe - Campus Maria's Voorzienigheid
City
Kortrijk
ZIP/Postal Code
B-8500
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Algemeen Ziekenhuis Sint-Augustinus
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Centre Regional Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Centro di Riferimento Oncologico - Aviano
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
I.R.C.C.S. Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Sanitaria Ospedaliera Ordine Mauriziano
City
Turin
ZIP/Postal Code
10128
Country
Italy
Facility Name
Clinica Universitaria
City
Turin
ZIP/Postal Code
10138
Country
Italy
Facility Name
Ospedale Civile
City
Voghera
ZIP/Postal Code
27058
Country
Italy
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
ZIP/Postal Code
1091 HA
Country
Netherlands
Facility Name
Academisch Medisch Centrum at University of Amsterdam
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
ZIP/Postal Code
7500 KA
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2300 CA
Country
Netherlands
Facility Name
Universitair Medisch Centrum St. Radboud - Nijmegen
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Hospitais da Universidade de Coimbra (HUC)
City
Coimbra
ZIP/Postal Code
3049
Country
Portugal
Facility Name
Hospital Universitario San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Instituto Valenciano De Oncologia
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Royal United Hospital
City
Bath
State/Province
England
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology NHS Trust
City
Merseyside
State/Province
England
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
James Cook University Hospital
City
Middlesbrough
State/Province
England
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Northern Centre for Cancer Treatment at Newcastle General Hospital
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre at Mount Vernon Hospital
City
Northwood
State/Province
England
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Nottingham City Hospital NHS Trust
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Oldchurch Hospital
City
Romford
State/Province
England
ZIP/Postal Code
RM7 OBE
Country
United Kingdom
Facility Name
Centre for Cancer Research and Cell Biology at Belfast City Hospital
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Western Infirmary
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G11 6NT
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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