Erlotinib or Observation in Treating Patients Who Have Undergone First-Line Chemotherapy for Ovarian Cancer, Peritoneal Cancer, or Fallopian Tube Cancer
NCT ID: NCT00263822
Last Updated: 2013-08-27
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
PHASE3
835 participants
INTERVENTIONAL
2005-09-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
NONE
Interventions
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erlotinib hydrochloride
Eligibility Criteria
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Inclusion Criteria
* 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
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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Antonio Jimeno
Role: STUDY_CHAIR
Hospital Universitario 12 de Octubre
Locations
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Prince of Wales Private Hospital
Randwick, New South Wales, Australia
Tamworth Base Hospital
Tamworth, New South Wales, Australia
Manning Base Hospital
Taree, New South Wales, Australia
Newcastle Mater Misericordiae Hospital
Waratah, New South Wales, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Royal Women's Hospital
Carlton, Victoria, Australia
Frankston Hospital
Frankston, Victoria, Australia
Murray Valley Private Hospital and Cancer Treatment Centre
Wodonga, Victoria, Australia
Sir Charles Gairdner Hospital - Nedlands
Nedlands, Western Australia, Australia
Landeskrankenhaus Klagenfurt
Klagenfurt, , Austria
A.o. Bezirkskrankenhaus Kufstein
Kufstein, , Austria
Centre Hospitalier de L' Agglomeration Montargoise
Amilly, , France
Centre Hospitalier General
Amilly, , France
Centre Hospital General Robert Ballanger
Aulnay-sous-Bois, , France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, , France
Institut Bergonie
Bordeaux, , France
Clinique Tivoli
Bordeaux, , France
Polyclinique Bordeaux Nord Aquitaine
Boucher, , France
Centre Regional Francois Baclesse
Caen, , France
Centre Hospitalier Regional de Chambery
Chambéry, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Hopital Louis Pasteur
Colmar, , France
Centre Hospitalier de Dax
Dax, , France
Clinique Pasteur
Évreux, , France
Centre Hospitalier de Gap
Gap, , France
Centre Hospitalier Departemental
La Roche-sur-Yon, , France
Clinique Victor Hugo
Le Mans, , France
Centre Hospitalier Bretagne Sud
Lorient, , France
Centre Leon Berard
Lyon, , France
Hopital Saint Joseph
Marseille, , France
Centre Hospitalier General de Mont de Marsan
Mont-de-Marsan, , France
Centre Hospitalier General Andre Boulloche
Montbéliard, , France
Centre Hospitalier de Montlucon
Montluçon, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , France
Hotel Dieu de Paris
Paris, , France
Institut Curie Hopital
Paris, , France
Polyclinique Francheville
Périgueux, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU Poitiers
Poitiers, , France
Institut Jean Godinot
Reims, , France
Centre Eugene Marquis
Rennes, , France
Clinique Armoricaine De Radiologie
Saint-Brieuc, , France
Centre Paul Strauss
Strasbourg, , France
Hopitaux Universitaire de Strasbourg
Strasbourg, , France
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, , France
Centre Hospitalier Valence
Valence, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Centro di Riferimento Oncologico - Aviano
Aviano, , Italy
Ospedale Sant Anna
Como, , Italy
Ospedale Santa Maria Goretti
Latina, , Italy
Ospedale Niguarda Ca'Granda
Milan, , Italy
Ospedale San Gerardo
Monza, , Italy
Universita di Torino
Turin, , Italy
Azienda Sanitaria Ospedaliera Ordine Mauriziano
Turin, , Italy
Ospedale di Circolo e Fondazione Macchi
Varese, , Italy
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, , Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, , Netherlands
Martini Ziekenhuis
Groningen, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Universitair Medisch Centrum St. Radboud - Nijmegen
Nijmegen, , Netherlands
Erasmus MC - Sophia Children's Hospital
Rotterdam, , Netherlands
Hospitais da Universidade de Coimbra (HUC)
Coimbra, , Portugal
Institut d'Oncologia Corachan
Barcelona, , Spain
Hospital Universitario San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Instituto Valenciano De Oncologia
Valencia, , Spain
Stoke Mandeville Hospital
Aylesbury-Buckinghamshire, England, United Kingdom
North Devon District Hospital
Barnstaple, England, United Kingdom
Royal United Hospital
Bath, England, United Kingdom
City Hospital - Birmingham
Birmingham, England, United Kingdom
Cumberland Infirmary
Carlisle, England, United Kingdom
Queen Elizabeth Hospital
Gateshead, England, United Kingdom
Ipswich Hospital
Ipswich, England, United Kingdom
University College Hospital
London, England, United Kingdom
Mid Kent Oncology Centre at Maidstone Hospital
Maidstone, England, United Kingdom
Queen Elizabeth The Queen Mother Hospital
Margate, England, United Kingdom
Clatterbridge Centre for Oncology
Merseyside, England, United Kingdom
James Cook University Hospital
Middlesbrough, England, United Kingdom
St. Mary's Hospital
Newport, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom
Norfolk and Norwich University Hospital
Norwich, England, United Kingdom
Royal Preston Hospital
Preston, England, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, England, United Kingdom
Wexham Park Hospital
Slough, Berkshire, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Staffordshire General Hospital
Stafford, England, United Kingdom
Yeovil District Hospital
Yeovil, England, United Kingdom
Gartnavel General Hospital
Glasgow, Scotland, United Kingdom
Bronglais District General Hospital
Aberystwyth, Wales, United Kingdom
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom
South West Wales Cancer Institute
Swansea, Wales, United Kingdom
Countries
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References
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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.
Other Identifiers
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EORTC-55041
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2004-004333-34
Identifier Type: -
Identifier Source: secondary_id
EORTC-55041
Identifier Type: -
Identifier Source: org_study_id