- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00263822
Erlotinib or Observation in Treating Patients Who Have Undergone First-Line Chemotherapy for Ovarian Cancer, Peritoneal Cancer, or Fallopian Tube Cancer
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
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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New South Wales
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Randwick, New South Wales, Australia, 2031
- Prince of Wales Private Hospital
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Tamworth, New South Wales, Australia, 2340
- Tamworth Base Hospital
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Taree, New South Wales, Australia, 2430
- Manning Base Hospital
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Waratah, New South Wales, Australia, 2298
- Newcastle Mater Misericordiae Hospital
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Queensland
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Brisbane, Queensland, Australia, 4029
- Royal Brisbane and Women's Hospital
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Victoria
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Carlton, Victoria, Australia, 3053
- Royal Women's Hospital
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Frankston, Victoria, Australia, 3199
- Frankston Hospital
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Wodonga, Victoria, Australia, 3690
- Murray Valley Private Hospital and Cancer Treatment Centre
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Sir Charles Gairdner Hospital - Nedlands
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Klagenfurt, Austria, 9026
- Landeskrankenhaus Klagenfurt
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Kufstein, Austria, 6330
- A.o. Bezirkskrankenhaus Kufstein
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Amilly, France, 45207
- Centre Hospitalier de L' Agglomeration Montargoise
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Amilly, France, 45207
- Centre Hospitalier General
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Aulnay Sous Bois, France, 93602
- Centre Hospital General Robert Ballanger
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Besancon, France, 25030
- Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
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Bordeaux, France, 33076
- Institut Bergonie
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Bordeaux, France, F-33000
- Clinique Tivoli
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Boucher, France, 33300
- Polyclinique Bordeaux Nord Aquitaine
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Caen, France, 14076
- Centre Regional Francois Baclesse
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Chambery, France, 73011
- Centre Hospitalier Regional de Chambery
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Clermont-Ferrand, France, 63011
- Centre Jean Perrin
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Colmar, France, 68024
- Hôpital Louis Pasteur
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Dax, France, 40107
- Centre Hospitalier de Dax
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Evreux, France, 27000
- Clinique Pasteur
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Gap, France, 05007
- Centre Hospitalier de Gap
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La Roche Sur Yon, France, F-85025
- Centre Hospitalier departemental
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Le Mans, France, F-72000
- Clinique Victor Hugo
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Lorient, France, 56322
- Centre Hospitalier Bretagne Sud
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Lyon, France, 69373
- Centre Leon Berard
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Marseille, France, 13008
- Hopital Saint Joseph
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Mont-de-Marsan, France, 40000
- Centre Hospitalier General de Mont de Marsan
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Montbeliard, France, 25209
- Centre Hospitalier General Andre Boulloche
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Montlucon, France, 03109
- Centre Hospitalier de Montlucon
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Montpellier, France, 34298
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
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Paris, France, 75181
- Hotel Dieu de Paris
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Paris, France, 75248
- Institut Curie Hopital
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Perigueux, France, 24004
- Polyclinique Francheville
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Pierre Benite, France, 69495
- Centre Hospitalier Lyon Sud
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Poitiers, France, 86021
- CHU Poitiers
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Reims, France, 51056
- Institut Jean Godinot
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Rennes, France, 35042
- Centre Eugène Marquis
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Saint Brieuc, France, F-22015
- Clinique Armoricaine de Radiologie
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Strasbourg, France, 67065
- Centre PAUL STRAUSS
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Strasbourg, France, 67091
- Hopitaux Universitaire de strasbourg
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Tours, France, 37044
- Centre Hospitalier Universitaire Bretonneau de Tours
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Valence, France, 26000
- Centre Hospitalier Valence
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Vandoeuvre-les-Nancy, France, 54511
- Centre Alexis Vautrin
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Aviano, Italy, 33081
- Centro di Riferimento Oncologico - Aviano
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Como, Italy, 22100
- Ospedale Sant Anna
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Latina, Italy, 04100
- Ospedale Santa Maria Goretti
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Milan, Italy, 20162
- Ospedale Niguarda Ca'Granda
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Monza, Italy, 20052
- Ospedale San Gerardo
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Turin, Italy, 10126
- Università di Torino
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Turin, Italy, 10128
- Azienda Sanitaria Ospedaliera Ordine Mauriziano
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Varese, Italy, 21100
- Ospedale di Circolo e Fondazione Macchi
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Amsterdam, Netherlands, 1091 HA
- Onze Lieve Vrouwe Gasthuis
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Amsterdam, Netherlands, 1066 CX
- Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
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Groningen, Netherlands
- Martini Ziekenhuis
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Leiden, Netherlands, 2300 RC
- Leiden University Medical Center
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Nijmegen, Netherlands, NL-6500 HB
- Universitair Medisch Centrum St. Radboud - Nijmegen
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Rotterdam, Netherlands, 3015 GJ
- Erasmus MC - Sophia Children's Hospital
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Coimbra, Portugal, 3049
- Hospitais da Universidade de Coimbra (HUC)
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Barcelona, Spain, 08017
- Institut d'Oncologia Corachan
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Madrid, Spain, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Spain, 28040
- Hospital Universitario San Carlos
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Oviedo, Spain, 33006
- Hospital Universitario Central de Asturias
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Valencia, Spain, 46009
- Instituto Valenciano de Oncología
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England
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Aylesbury-Buckinghamshire, England, United Kingdom, HP21 8AL
- Stoke Mandeville Hospital
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Barnstaple, England, United Kingdom, EX31 4JB
- North Devon District Hospital
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Bath, England, United Kingdom, BA1 3NG
- Royal United Hospital
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Birmingham, England, United Kingdom, B18 7QH
- City Hospital - Birmingham
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Carlisle, England, United Kingdom, CA2 7HY
- Cumberland Infirmary
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Gateshead, England, United Kingdom, NE9 6SX
- Queen Elizabeth Hospital
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Ipswich, England, United Kingdom, IP4 5PD
- Ipswich Hospital
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London, England, United Kingdom, NW1 2BU
- University College Hospital
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Maidstone, England, United Kingdom, ME16 9QQ
- Mid Kent Oncology Centre at Maidstone Hospital
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Margate, England, United Kingdom, CT9 4AN
- Queen Elizabeth the Queen Mother Hospital
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Merseyside, England, United Kingdom, CH63 4JY
- Clatterbridge Centre for Oncology
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Middlesbrough, England, United Kingdom, TS4 3BW
- James Cook University Hospital
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Newport, England, United Kingdom, PO30 5TG
- St. Mary's Hospital
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Northwood, England, United Kingdom, HA6 2RN
- Mount Vernon Cancer Centre at Mount Vernon Hospital
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Norwich, England, United Kingdom, NR4 7UY
- Norfolk and Norwich University Hospital
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Preston, England, United Kingdom, PR2 9HT
- Royal Preston Hospital
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Shrewsbury, England, United Kingdom, SY3 8XQ
- Royal Shrewsbury Hospital
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Slough, Berkshire, England, United Kingdom, SL2 4HL
- Wexham Park Hospital
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Southampton, England, United Kingdom, SO16 6YD
- Southampton General Hospital
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Stafford, England, United Kingdom, ST16 3SA
- Staffordshire General Hospital
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Yeovil, England, United Kingdom, BA21 4AT
- Yeovil District Hospital
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Scotland
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Glasgow, Scotland, United Kingdom, G12 0YN
- Gartnavel General Hospital
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Wales
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Aberystwyth, Wales, United Kingdom, SY23 1ER
- Bronglais District General Hospital
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Cardiff, Wales, United Kingdom, CF14 2TL
- Velindre Cancer Center at Velindre Hospital
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Swansea, Wales, United Kingdom, SA2 8QA
- South West Wales Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Progression-free survival
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Secondary Outcome Measures
Outcome Measure |
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Overall survival
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Quality of life
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Adverse event profile
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Cutaneous toxicity (rash or acne [papulo-pustular rash])
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Collaborators and Investigators
Investigators
- Study Chair: Antonio Jimeno, Hospital Universitario 12 de Octubre
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Fallopian Tube Diseases
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Erlotinib Hydrochloride
Other Study ID Numbers
- EORTC-55041
- EUDRACT-2004-004333-34
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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