Erlotinib or Observation in Treating Patients Who Have Undergone First-Line Chemotherapy for Ovarian Cancer, Peritoneal Cancer, or Fallopian Tube Cancer
- Conditions
- Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity Cancer
- Registration Number
- NCT00263822
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 835
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival
- Secondary Outcome Measures
Name Time Method Overall survival Adverse event profile Quality of life Cutaneous toxicity (rash or acne [papulo-pustular rash])
Trial Locations
- Locations (92)
Centre Leon Berard
🇫🇷Lyon, France
Clinique Victor Hugo
🇫🇷Le Mans, France
Ospedale Santa Maria Goretti
🇮🇹Latina, Italy
Universita di Torino
🇮🇹Turin, Italy
Clinique Pasteur
🇫🇷Evreux, France
Centre Hospitalier Bretagne Sud
🇫🇷Lorient, France
Centre Hospitalier General de Mont de Marsan
🇫🇷Mont-de-Marsan, France
Centre Hospitalier General Andre Boulloche
🇫🇷Montbeliard, France
Ospedale Sant Anna
🇮🇹Como, Italy
Centre Hospitalier de Gap
🇫🇷Gap, France
Centre Hospitalier Regional de Chambery
🇫🇷Chambery, France
Ospedale Niguarda Ca'Granda
🇮🇹Milan, Italy
Centre Regional Francois Baclesse
🇫🇷Caen, France
Ospedale San Gerardo
🇮🇹Monza, Italy
Centre Hospitalier de Montlucon
🇫🇷Montlucon, France
Universitair Medisch Centrum St. Radboud - Nijmegen
🇳🇱Nijmegen, Netherlands
Polyclinique Francheville
🇫🇷Perigueux, France
Centre Alexis Vautrin
🇫🇷Vandoeuvre-les-Nancy, France
Azienda Sanitaria Ospedaliera Ordine Mauriziano
🇮🇹Turin, Italy
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
🇫🇷Montpellier, France
Centre Hospitalier Departemental
🇫🇷La Roche Sur Yon, France
Mount Vernon Cancer Centre at Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
Institut d'Oncologia Corachan
🇪🇸Barcelona, Spain
Hospital Universitario San Carlos
🇪🇸Madrid, Spain
Centro di Riferimento Oncologico - Aviano
🇮🇹Aviano, Italy
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
🇳🇱Amsterdam, Netherlands
Ospedale di Circolo e Fondazione Macchi
🇮🇹Varese, Italy
North Devon District Hospital
🇬🇧Barnstaple, England, United Kingdom
Royal Preston Hospital
🇬🇧Preston, England, United Kingdom
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Netherlands
Martini Ziekenhuis
🇳🇱Groningen, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Erasmus MC - Sophia Children's Hospital
🇳🇱Rotterdam, Netherlands
CHU Poitiers
🇫🇷Poitiers, France
Hotel Dieu de Paris
🇫🇷Paris, France
Hopital Saint Joseph
🇫🇷Marseille, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France
Institut Jean Godinot
🇫🇷Reims, France
Centre Eugene Marquis
🇫🇷Rennes, France
Clinique Armoricaine De Radiologie
🇫🇷Saint Brieuc, France
Centre Paul Strauss
🇫🇷Strasbourg, France
Centre Hospitalier Universitaire Bretonneau de Tours
🇫🇷Tours, France
Centre Hospitalier Valence
🇫🇷Valence, France
Institut Curie Hopital
🇫🇷Paris, France
Wexham Park Hospital
🇬🇧Slough, Berkshire, England, United Kingdom
Manning Base Hospital
🇦🇺Taree, New South Wales, Australia
Tamworth Base Hospital
🇦🇺Tamworth, New South Wales, Australia
Newcastle Mater Misericordiae Hospital
🇦🇺Waratah, New South Wales, Australia
Landeskrankenhaus Klagenfurt
🇦🇹Klagenfurt, Austria
A.o. Bezirkskrankenhaus Kufstein
🇦🇹Kufstein, Austria
Institut Bergonie
🇫🇷Bordeaux, France
Centre Hospitalier de L' Agglomeration Montargoise
🇫🇷Amilly, France
Centre Hospitalier General
🇫🇷Amilly, France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
🇫🇷Besancon, France
Clinique Tivoli
🇫🇷Bordeaux, France
Polyclinique Bordeaux Nord Aquitaine
🇫🇷Boucher, France
Centre Hospitalier de Dax
🇫🇷Dax, France
Hopitaux Universitaire de Strasbourg
🇫🇷Strasbourg, France
Instituto Valenciano De Oncologia
🇪🇸Valencia, Spain
Royal United Hospital
🇬🇧Bath, England, United Kingdom
City Hospital - Birmingham
🇬🇧Birmingham, England, United Kingdom
St. Mary's Hospital
🇬🇧Newport, England, United Kingdom
Clatterbridge Centre for Oncology
🇬🇧Merseyside, England, United Kingdom
Queen Elizabeth The Queen Mother Hospital
🇬🇧Margate, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
Staffordshire General Hospital
🇬🇧Stafford, England, United Kingdom
Royal Shrewsbury Hospital
🇬🇧Shrewsbury, England, United Kingdom
South West Wales Cancer Institute
🇬🇧Swansea, Wales, United Kingdom
Velindre Cancer Center at Velindre Hospital
🇬🇧Cardiff, Wales, United Kingdom
Royal Women's Hospital
🇦🇺Carlton, Victoria, Australia
Murray Valley Private Hospital and Cancer Treatment Centre
🇦🇺Wodonga, Victoria, Australia
Prince of Wales Private Hospital
🇦🇺Randwick, New South Wales, Australia
Royal Brisbane and Women's Hospital
🇦🇺Brisbane, Queensland, Australia
Sir Charles Gairdner Hospital - Nedlands
🇦🇺Nedlands, Western Australia, Australia
Frankston Hospital
🇦🇺Frankston, Victoria, Australia
Centre Hospital General Robert Ballanger
🇫🇷Aulnay Sous Bois, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Hopital Louis Pasteur
🇫🇷Colmar, France
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
Mid Kent Oncology Centre at Maidstone Hospital
🇬🇧Maidstone, England, United Kingdom
Hospitais da Universidade de Coimbra (HUC)
🇵🇹Coimbra, Portugal
Queen Elizabeth Hospital
🇬🇧Gateshead, England, United Kingdom
Ipswich Hospital
🇬🇧Ipswich, England, United Kingdom
Gartnavel General Hospital
🇬🇧Glasgow, Scotland, United Kingdom
Norfolk and Norwich University Hospital
🇬🇧Norwich, England, United Kingdom
Stoke Mandeville Hospital
🇬🇧Aylesbury-Buckinghamshire, England, United Kingdom
Cumberland Infirmary
🇬🇧Carlisle, England, United Kingdom
University College Hospital
🇬🇧London, England, United Kingdom
James Cook University Hospital
🇬🇧Middlesbrough, England, United Kingdom
Yeovil District Hospital
🇬🇧Yeovil, England, United Kingdom
Bronglais District General Hospital
🇬🇧Aberystwyth, Wales, United Kingdom