Back to resultsErlotinib or Observation in Treating Patients Who Have Undergone First-Line Chemotherapy for Ovarian Cancer, Peritoneal Cancer, or Fallopian Tube Cancer
Primary Purpose
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
erlotinib hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, primary peritoneal cavity cancer, fallopian tube cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer meeting 1 of the following criteria: High-risk stage I disease, as defined by grade 3, aneuploid grade 1 or 2, or clear cell disease Stage II, III, or IV disease Completed first-line therapy within the past 6 weeks Received a platinum derivative (carboplatin or cisplatin) alone or in combination with other agents for 6-9 courses Must have achieved complete response/no evidence of disease, partial response, or stabilization of disease after therapy No adenocarcinoma of unknown origin No known brain metastases or leptomeningeal disease PATIENT CHARACTERISTICS: Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic Platelet count ≥ 100,000/mm^3 WBC ≥ 2,000/mm^3 Hepatic AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN in patients with known liver metastases) Bilirubin ≤ 1.5 times ULN Alkaline phosphatase ≤ 5 times ULN except in patients with known bone metastases PT and PTT ≤ 1.5 times ULN Renal Creatinine ≤ 2 times ULN Cardiovascular No myocardial infarction within past 6 months No second- or third-degree heart block without pacemaker Gastrointestinal No active peptic ulcer disease No gastrointestinal tract disease that would interfere with ability to take oral medications, affect absorption, or require parenteral nutrition No uncontrolled inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No significant dermatologic disease No inflammatory changes to the surface of the eye No history of allergic reaction to compounds of similar chemical composition as erlotinib No other significant medical condition or neurologic or psychiatric disorder No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or cone-biopsied carcinoma in situ of the cervix No psychiatric illness or familial, geographic, or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy No prior therapy targeting epidermal growth factor receptor No concurrent immunotherapy Chemotherapy See Disease Characteristics See Surgery No concurrent chemotherapy Endocrine therapy No concurrent hormonal therapy Radiotherapy No prior radiotherapy unless completed more than 5 years ago AND outside the abdomen/pelvis Surgery Interval debulking surgery after 3 courses of chemotherapy and second-look surgery at the end of chemotherapy allowed as per study EORTC-55971/NCIC OV13/Chorus Other No other prior or concurrent investigational agents No other concurrent anticancer treatment Concurrent participation in study EORTC-55971/NCIC-OV13/Chorus allowed
Sites / Locations
- Prince of Wales Private Hospital
- Tamworth Base Hospital
- Manning Base Hospital
- Newcastle Mater Misericordiae Hospital
- Royal Brisbane and Women's Hospital
- Royal Women's Hospital
- Frankston Hospital
- Murray Valley Private Hospital and Cancer Treatment Centre
- Sir Charles Gairdner Hospital - Nedlands
- Landeskrankenhaus Klagenfurt
- A.o. Bezirkskrankenhaus Kufstein
- Centre Hospitalier de L' Agglomeration Montargoise
- Centre Hospitalier General
- Centre Hospital General Robert Ballanger
- Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
- Institut Bergonie
- Clinique Tivoli
- Polyclinique Bordeaux Nord Aquitaine
- Centre Regional Francois Baclesse
- Centre Hospitalier Regional de Chambery
- Centre Jean Perrin
- Hopital Louis Pasteur
- Centre Hospitalier de Dax
- Clinique Pasteur
- Centre Hospitalier de Gap
- Centre Hospitalier Departemental
- Clinique Victor Hugo
- Centre Hospitalier Bretagne Sud
- Centre Leon Berard
- Hopital Saint Joseph
- Centre Hospitalier General de Mont de Marsan
- Centre Hospitalier General Andre Boulloche
- Centre Hospitalier de Montlucon
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
- Hotel Dieu de Paris
- Institut Curie Hopital
- Polyclinique Francheville
- Centre Hospitalier Lyon Sud
- CHU Poitiers
- Institut Jean Godinot
- Centre Eugene Marquis
- Clinique Armoricaine De Radiologie
- Centre Paul Strauss
- Hopitaux Universitaire de Strasbourg
- Centre Hospitalier Universitaire Bretonneau de Tours
- Centre Hospitalier Valence
- Centre Alexis Vautrin
- Centro di Riferimento Oncologico - Aviano
- Ospedale Sant Anna
- Ospedale Santa Maria Goretti
- Ospedale Niguarda Ca'Granda
- Ospedale San Gerardo
- Universita di Torino
- Azienda Sanitaria Ospedaliera Ordine Mauriziano
- Ospedale di Circolo e Fondazione Macchi
- Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
- Onze Lieve Vrouwe Gasthuis
- Martini Ziekenhuis
- Leiden University Medical Center
- Universitair Medisch Centrum St. Radboud - Nijmegen
- Erasmus MC - Sophia Children's Hospital
- Hospitais da Universidade de Coimbra (HUC)
- Institut d'Oncologia Corachan
- Hospital Universitario San Carlos
- Hospital Universitario 12 de Octubre
- Hospital Universitario Central de Asturias
- Instituto Valenciano De Oncologia
- Stoke Mandeville Hospital
- North Devon District Hospital
- Royal United Hospital
- City Hospital - Birmingham
- Cumberland Infirmary
- Queen Elizabeth Hospital
- Ipswich Hospital
- University College Hospital
- Mid Kent Oncology Centre at Maidstone Hospital
- Queen Elizabeth The Queen Mother Hospital
- Clatterbridge Centre for Oncology
- James Cook University Hospital
- St. Mary's Hospital
- Mount Vernon Cancer Centre at Mount Vernon Hospital
- Norfolk and Norwich University Hospital
- Royal Preston Hospital
- Royal Shrewsbury Hospital
- Wexham Park Hospital
- Southampton General Hospital
- Staffordshire General Hospital
- Yeovil District Hospital
- Gartnavel General Hospital
- Bronglais District General Hospital
- Velindre Cancer Center at Velindre Hospital
- South West Wales Cancer Institute
Outcomes
Primary Outcome Measures
Progression-free survival
Secondary Outcome Measures
Overall survival
Adverse event profile
Quality of life
Cutaneous toxicity (rash or acne [papulo-pustular rash])
Full Information
NCT ID
NCT00263822
First Posted
December 7, 2005
Last Updated
August 26, 2013
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
1. Study Identification
Unique Protocol Identification Number
NCT00263822
Brief Title
Erlotinib or Observation in Treating Patients Who Have Undergone First-Line Chemotherapy for Ovarian Cancer, Peritoneal Cancer, or Fallopian Tube Cancer
Official Title
A Randomized, Multicenter, Phase III Study of Erlotinib Versus Observation in Patients With no Evidence of Disease Progression After First Line, Platinum-Based Chemotherapy For High-Risk Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
February 2008 (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: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sometimes after treatment, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether erlotinib is more effective than observation after first-line chemotherapy in treating patients with ovarian cancer, peritoneal cancer, or fallopian tube cancer.
PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works compared to observation in treating patients who have undergone first-line chemotherapy for ovarian cancer, peritoneal cancer, or fallopian tube cancer.
Detailed Description
OBJECTIVES:
Primary
Compare the benefits, in terms of progression-free survival, of maintenance therapy comprising erlotinib vs observation in patients with responding or stable disease after first-line, platinum-based chemotherapy for high-risk stage I or stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer.
Secondary
Compare the overall survival of patients treated with these regimens.
Determine the safety of erlotinib in these patients.
Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (I-II vs III-IV), participating center, age (≤ 65 vs > 65), response to first-line therapy (no evidence of disease/complete response vs partial response vs stable disease), and first-line therapy (platinum-based vs platinum/taxane combination vs platinum-based triplet). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive oral erlotinib once daily for up to 2 years in the absence of disease progression or unacceptable toxicity.
Arm II: Patients undergo observation as per standard of care. Quality of life is assessed at baseline and then every 3 months for up to 2 years.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 830 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
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Keywords
stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, primary peritoneal cavity cancer, fallopian tube cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized
Enrollment
835 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
erlotinib hydrochloride
Primary Outcome Measure Information:
Title
Progression-free survival
Secondary Outcome Measure Information:
Title
Overall survival
Title
Adverse event profile
Title
Quality of life
Title
Cutaneous toxicity (rash or acne [papulo-pustular rash])
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer meeting 1 of the following criteria:
High-risk stage I disease, as defined by grade 3, aneuploid grade 1 or 2, or clear cell disease
Stage II, III, or IV disease
Completed first-line therapy within the past 6 weeks
Received a platinum derivative (carboplatin or cisplatin) alone or in combination with other agents for 6-9 courses
Must have achieved complete response/no evidence of disease, partial response, or stabilization of disease after therapy
No adenocarcinoma of unknown origin
No known brain metastases or leptomeningeal disease
PATIENT CHARACTERISTICS:
Performance status
ECOG 0-1
Life expectancy
Not specified
Hematopoietic
Platelet count ≥ 100,000/mm^3
WBC ≥ 2,000/mm^3
Hepatic
AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN in patients with known liver metastases)
Bilirubin ≤ 1.5 times ULN
Alkaline phosphatase ≤ 5 times ULN except in patients with known bone metastases
PT and PTT ≤ 1.5 times ULN
Renal
Creatinine ≤ 2 times ULN
Cardiovascular
No myocardial infarction within past 6 months
No second- or third-degree heart block without pacemaker
Gastrointestinal
No active peptic ulcer disease
No gastrointestinal tract disease that would interfere with ability to take oral medications, affect absorption, or require parenteral nutrition
No uncontrolled inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No significant dermatologic disease
No inflammatory changes to the surface of the eye
No history of allergic reaction to compounds of similar chemical composition as erlotinib
No other significant medical condition or neurologic or psychiatric disorder
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or cone-biopsied carcinoma in situ of the cervix
No psychiatric illness or familial, geographic, or social situation that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
No prior therapy targeting epidermal growth factor receptor
No concurrent immunotherapy
Chemotherapy
See Disease Characteristics
See Surgery
No concurrent chemotherapy
Endocrine therapy
No concurrent hormonal therapy
Radiotherapy
No prior radiotherapy unless completed more than 5 years ago AND outside the abdomen/pelvis
Surgery
Interval debulking surgery after 3 courses of chemotherapy and second-look surgery at the end of chemotherapy allowed as per study EORTC-55971/NCIC OV13/Chorus
Other
No other prior or concurrent investigational agents
No other concurrent anticancer treatment
Concurrent participation in study EORTC-55971/NCIC-OV13/Chorus allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Jimeno
Organizational Affiliation
Hospital Universitario 12 de Octubre
Official's Role
Study Chair
Facility Information:
Facility Name
Prince of Wales Private Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Tamworth Base Hospital
City
Tamworth
State/Province
New South Wales
ZIP/Postal Code
2340
Country
Australia
Facility Name
Manning Base Hospital
City
Taree
State/Province
New South Wales
ZIP/Postal Code
2430
Country
Australia
Facility Name
Newcastle Mater Misericordiae Hospital
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Royal Women's Hospital
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Frankston Hospital
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Murray Valley Private Hospital and Cancer Treatment Centre
City
Wodonga
State/Province
Victoria
ZIP/Postal Code
3690
Country
Australia
Facility Name
Sir Charles Gairdner Hospital - Nedlands
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Landeskrankenhaus Klagenfurt
City
Klagenfurt
ZIP/Postal Code
9026
Country
Austria
Facility Name
A.o. Bezirkskrankenhaus Kufstein
City
Kufstein
ZIP/Postal Code
6330
Country
Austria
Facility Name
Centre Hospitalier de L' Agglomeration Montargoise
City
Amilly
ZIP/Postal Code
45207
Country
France
Facility Name
Centre Hospitalier General
City
Amilly
ZIP/Postal Code
45207
Country
France
Facility Name
Centre Hospital General Robert Ballanger
City
Aulnay Sous Bois
ZIP/Postal Code
93602
Country
France
Facility Name
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Clinique Tivoli
City
Bordeaux
ZIP/Postal Code
F-33000
Country
France
Facility Name
Polyclinique Bordeaux Nord Aquitaine
City
Boucher
ZIP/Postal Code
33300
Country
France
Facility Name
Centre Regional Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Hospitalier Regional de Chambery
City
Chambery
ZIP/Postal Code
73011
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Hopital Louis Pasteur
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
Centre Hospitalier de Dax
City
Dax
ZIP/Postal Code
40107
Country
France
Facility Name
Clinique Pasteur
City
Evreux
ZIP/Postal Code
27000
Country
France
Facility Name
Centre Hospitalier de Gap
City
Gap
ZIP/Postal Code
05007
Country
France
Facility Name
Centre Hospitalier Departemental
City
La Roche Sur Yon
ZIP/Postal Code
F-85025
Country
France
Facility Name
Clinique Victor Hugo
City
Le Mans
ZIP/Postal Code
F-72000
Country
France
Facility Name
Centre Hospitalier Bretagne Sud
City
Lorient
ZIP/Postal Code
56322
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Hopital Saint Joseph
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Centre Hospitalier General de Mont de Marsan
City
Mont-de-Marsan
ZIP/Postal Code
40000
Country
France
Facility Name
Centre Hospitalier General Andre Boulloche
City
Montbeliard
ZIP/Postal Code
25209
Country
France
Facility Name
Centre Hospitalier de Montlucon
City
Montlucon
ZIP/Postal Code
03109
Country
France
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Hotel Dieu de Paris
City
Paris
ZIP/Postal Code
75181
Country
France
Facility Name
Institut Curie Hopital
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Polyclinique Francheville
City
Perigueux
ZIP/Postal Code
24004
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Institut Jean Godinot
City
Reims
ZIP/Postal Code
51056
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Clinique Armoricaine De Radiologie
City
Saint Brieuc
ZIP/Postal Code
F-22015
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Facility Name
Hopitaux Universitaire de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Centre Hospitalier Universitaire Bretonneau de Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Centre Hospitalier Valence
City
Valence
ZIP/Postal Code
26000
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Centro di Riferimento Oncologico - Aviano
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
Ospedale Sant Anna
City
Como
ZIP/Postal Code
22100
Country
Italy
Facility Name
Ospedale Santa Maria Goretti
City
Latina
ZIP/Postal Code
04100
Country
Italy
Facility Name
Ospedale Niguarda Ca'Granda
City
Milan
ZIP/Postal Code
20162
Country
Italy
Facility Name
Ospedale San Gerardo
City
Monza
ZIP/Postal Code
20052
Country
Italy
Facility Name
Universita di Torino
City
Turin
ZIP/Postal Code
10126
Country
Italy
Facility Name
Azienda Sanitaria Ospedaliera Ordine Mauriziano
City
Turin
ZIP/Postal Code
10128
Country
Italy
Facility Name
Ospedale di Circolo e Fondazione Macchi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
ZIP/Postal Code
1091 HA
Country
Netherlands
Facility Name
Martini Ziekenhuis
City
Groningen
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2300 RC
Country
Netherlands
Facility Name
Universitair Medisch Centrum St. Radboud - Nijmegen
City
Nijmegen
ZIP/Postal Code
NL-6500 HB
Country
Netherlands
Facility Name
Erasmus MC - Sophia Children's Hospital
City
Rotterdam
ZIP/Postal Code
3015 GJ
Country
Netherlands
Facility Name
Hospitais da Universidade de Coimbra (HUC)
City
Coimbra
ZIP/Postal Code
3049
Country
Portugal
Facility Name
Institut d'Oncologia Corachan
City
Barcelona
ZIP/Postal Code
08017
Country
Spain
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
Hospital Universitario Central de Asturias
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
Facility Name
Instituto Valenciano De Oncologia
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Stoke Mandeville Hospital
City
Aylesbury-Buckinghamshire
State/Province
England
ZIP/Postal Code
HP21 8AL
Country
United Kingdom
Facility Name
North Devon District Hospital
City
Barnstaple
State/Province
England
ZIP/Postal Code
EX31 4JB
Country
United Kingdom
Facility Name
Royal United Hospital
City
Bath
State/Province
England
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
City Hospital - Birmingham
City
Birmingham
State/Province
England
ZIP/Postal Code
B18 7QH
Country
United Kingdom
Facility Name
Cumberland Infirmary
City
Carlisle
State/Province
England
ZIP/Postal Code
CA2 7HY
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
Gateshead
State/Province
England
ZIP/Postal Code
NE9 6SX
Country
United Kingdom
Facility Name
Ipswich Hospital
City
Ipswich
State/Province
England
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Facility Name
University College Hospital
City
London
State/Province
England
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
Mid Kent Oncology Centre at Maidstone Hospital
City
Maidstone
State/Province
England
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Queen Elizabeth The Queen Mother Hospital
City
Margate
State/Province
England
ZIP/Postal Code
CT9 4AN
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology
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
St. Mary's Hospital
City
Newport
State/Province
England
ZIP/Postal Code
PO30 5TG
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
Norfolk and Norwich University Hospital
City
Norwich
State/Province
England
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Royal Preston Hospital
City
Preston
State/Province
England
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Royal Shrewsbury Hospital
City
Shrewsbury
State/Province
England
ZIP/Postal Code
SY3 8XQ
Country
United Kingdom
Facility Name
Wexham Park Hospital
City
Slough, Berkshire
State/Province
England
ZIP/Postal Code
SL2 4HL
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Staffordshire General Hospital
City
Stafford
State/Province
England
ZIP/Postal Code
ST16 3SA
Country
United Kingdom
Facility Name
Yeovil District Hospital
City
Yeovil
State/Province
England
ZIP/Postal Code
BA21 4AT
Country
United Kingdom
Facility Name
Gartnavel General Hospital
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Bronglais District General Hospital
City
Aberystwyth
State/Province
Wales
ZIP/Postal Code
SY23 1ER
Country
United Kingdom
Facility Name
Velindre Cancer Center at Velindre Hospital
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
South West Wales Cancer Institute
City
Swansea
State/Province
Wales
ZIP/Postal Code
SA2 8QA
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
24366937
Citation
Vergote IB, Jimeno A, Joly F, Katsaros D, Coens C, Despierre E, Marth C, Hall M, Steer CB, Colombo N, Lesoin A, Casado A, Reinthaller A, Green J, Buck M, Ray-Coquard I, Ferrero A, Favier L, Reed NS, Cure H, Pujade-Lauraine E. Randomized phase III study of erlotinib versus observation in patients with no evidence of disease progression after first-line platin-based chemotherapy for ovarian carcinoma: a European Organisation for Research and Treatment of Cancer-Gynaecological Cancer Group, and Gynecologic Cancer Intergroup study. J Clin Oncol. 2014 Feb 1;32(4):320-6. doi: 10.1200/JCO.2013.50.5669. Epub 2013 Dec 23.
Results Reference
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Erlotinib or Observation in Treating Patients Who Have Undergone First-Line Chemotherapy for Ovarian Cancer, Peritoneal Cancer, or Fallopian Tube Cancer
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