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CompletedNCT00263822Updated Aug 27, 2013

Erlotinib or Observation in Treating Patients Who Have Undergone First-Line Chemotherapy for Ovarian Cancer, Peritoneal Cancer, or Fallopian Tube Cancer

A Phase 3 interventional study of erlotinib hydrochloride in Fallopian Tube Cancer, Ovarian Cancer and Primary Peritoneal Cavity Cancer, sponsored by European Organisation for Research and Treatment of Cancer - EORTC. Completed at 92 sites in 8 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-27.

Sponsored by European Organisation for Research and Treatment of Cancer - EORTC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
835
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 835 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

European Organisation for Research and Treatment of Cancer - EORTC is the lead sponsor of 342 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Masking
None (open label)
Enrollment
835 participants (actual)

Interventions

  • Drugerlotinib hydrochloride
06

What researchers measure

Primary outcomes

  1. Progression-free survival

Secondary outcomes

  1. Overall survival

  2. Adverse event profile

  3. Quality of life

  4. Cutaneous toxicity (rash or acne [papulo-pustular rash])

07

Study locations

92 sites
  • Prince of Wales Private Hospital
    Randwick, New South Wales 2031, Australia
  • Tamworth Base Hospital
    Tamworth, New South Wales 2340, Australia
  • Manning Base Hospital
    Taree, New South Wales 2430, Australia
  • Newcastle Mater Misericordiae Hospital
    Waratah, New South Wales 2298, Australia
  • Royal Brisbane and Women's Hospital
    Brisbane, Queensland 4029, Australia
  • Royal Women's Hospital
    Carlton, Victoria 3053, Australia
  • Frankston Hospital
    Frankston, Victoria 3199, Australia
  • Murray Valley Private Hospital and Cancer Treatment Centre
    Wodonga, Victoria 3690, Australia
  • Sir Charles Gairdner Hospital - Nedlands
    Nedlands, Western Australia 6009, Australia
  • Landeskrankenhaus Klagenfurt
    Klagenfurt, 9026, Austria
  • A.o. Bezirkskrankenhaus Kufstein
    Kufstein, 6330, Austria
  • Centre Hospitalier de L' Agglomeration Montargoise
    Amilly, 45207, France
  • Centre Hospitalier General
    Amilly, 45207, France
  • Centre Hospital General Robert Ballanger
    Aulnay Sous Bois, 93602, France
  • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
    Besancon, 25030, France
  • Institut Bergonie
    Bordeaux, 33076, France
  • Clinique Tivoli
    Bordeaux, F-33000, France
  • Polyclinique Bordeaux Nord Aquitaine
    Boucher, 33300, France
  • Centre Regional Francois Baclesse
    Caen, 14076, France
  • Centre Hospitalier Regional de Chambery
    Chambery, 73011, France
  • Centre Jean Perrin
    Clermont-Ferrand, 63011, France
  • Hopital Louis Pasteur
    Colmar, 68024, France
  • Centre Hospitalier de Dax
    Dax, 40107, France
  • Clinique Pasteur
    Evreux, 27000, France
  • Centre Hospitalier de Gap
    Gap, 05007, France
  • Centre Hospitalier Departemental
    La Roche Sur Yon, F-85025, France
  • Clinique Victor Hugo
    Le Mans, F-72000, France
  • Centre Hospitalier Bretagne Sud
    Lorient, 56322, France
  • Centre Leon Berard
    Lyon, 69373, France
  • Hopital Saint Joseph
    Marseille, 13008, France
  • Centre Hospitalier General de Mont de Marsan
    Mont-de-Marsan, 40000, France
  • Centre Hospitalier General Andre Boulloche
    Montbeliard, 25209, France
  • Centre Hospitalier de Montlucon
    Montlucon, 03109, France
  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
    Montpellier, 34298, France
  • Hotel Dieu de Paris
    Paris, 75181, France
  • Institut Curie Hopital
    Paris, 75248, France
  • Polyclinique Francheville
    Perigueux, 24004, France
  • Centre Hospitalier Lyon Sud
    Pierre Benite, 69495, France
  • CHU Poitiers
    Poitiers, 86021, France
  • Institut Jean Godinot
    Reims, 51056, France
  • Centre Eugene Marquis
    Rennes, 35042, France
  • Clinique Armoricaine De Radiologie
    Saint Brieuc, F-22015, France
  • Centre Paul Strauss
    Strasbourg, 67065, France
  • Hopitaux Universitaire de Strasbourg
    Strasbourg, 67091, France
  • Centre Hospitalier Universitaire Bretonneau de Tours
    Tours, 37044, France
  • Centre Hospitalier Valence
    Valence, 26000, France
  • Centre Alexis Vautrin
    Vandoeuvre-les-Nancy, 54511, France
  • Centro di Riferimento Oncologico - Aviano
    Aviano, 33081, Italy
  • Ospedale Sant Anna
    Como, 22100, Italy
  • Ospedale Santa Maria Goretti
    Latina, 04100, Italy
  • Ospedale Niguarda Ca'Granda
    Milan, 20162, Italy
  • Ospedale San Gerardo
    Monza, 20052, Italy
  • Universita di Torino
    Turin, 10126, Italy
  • Azienda Sanitaria Ospedaliera Ordine Mauriziano
    Turin, 10128, Italy
  • Ospedale di Circolo e Fondazione Macchi
    Varese, 21100, Italy
  • Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
    Amsterdam, 1066 CX, Netherlands
  • Onze Lieve Vrouwe Gasthuis
    Amsterdam, 1091 HA, Netherlands
  • Martini Ziekenhuis
    Groningen, Netherlands
  • Leiden University Medical Center
    Leiden, 2300 RC, Netherlands
  • Universitair Medisch Centrum St. Radboud - Nijmegen
    Nijmegen, NL-6500 HB, Netherlands
  • Erasmus MC - Sophia Children's Hospital
    Rotterdam, 3015 GJ, Netherlands
  • Hospitais da Universidade de Coimbra (HUC)
    Coimbra, 3049, Portugal
  • Institut d'Oncologia Corachan
    Barcelona, 08017, Spain
  • Hospital Universitario San Carlos
    Madrid, 28040, Spain
  • Hospital Universitario 12 de Octubre
    Madrid, 28041, Spain
  • Hospital Universitario Central de Asturias
    Oviedo, 33006, Spain
  • Instituto Valenciano De Oncologia
    Valencia, 46009, Spain
  • Stoke Mandeville Hospital
    Aylesbury-Buckinghamshire, England HP21 8AL, United Kingdom
  • North Devon District Hospital
    Barnstaple, England EX31 4JB, United Kingdom
  • Royal United Hospital
    Bath, England BA1 3NG, United Kingdom
  • City Hospital - Birmingham
    Birmingham, England B18 7QH, United Kingdom
  • Cumberland Infirmary
    Carlisle, England CA2 7HY, United Kingdom
  • Queen Elizabeth Hospital
    Gateshead, England NE9 6SX, United Kingdom
  • Ipswich Hospital
    Ipswich, England IP4 5PD, United Kingdom
  • University College Hospital
    London, England NW1 2BU, United Kingdom
  • Mid Kent Oncology Centre at Maidstone Hospital
    Maidstone, England ME16 9QQ, United Kingdom
  • Queen Elizabeth The Queen Mother Hospital
    Margate, England CT9 4AN, United Kingdom
  • Clatterbridge Centre for Oncology
    Merseyside, England CH63 4JY, United Kingdom
  • James Cook University Hospital
    Middlesbrough, England TS4 3BW, United Kingdom
  • St. Mary's Hospital
    Newport, England PO30 5TG, United Kingdom
  • Mount Vernon Cancer Centre at Mount Vernon Hospital
    Northwood, England HA6 2RN, United Kingdom
  • Norfolk and Norwich University Hospital
    Norwich, England NR4 7UY, United Kingdom
  • Royal Preston Hospital
    Preston, England PR2 9HT, United Kingdom
  • Royal Shrewsbury Hospital
    Shrewsbury, England SY3 8XQ, United Kingdom
  • Wexham Park Hospital
    Slough, Berkshire, England SL2 4HL, United Kingdom
  • Southampton General Hospital
    Southampton, England SO16 6YD, United Kingdom
  • Staffordshire General Hospital
    Stafford, England ST16 3SA, United Kingdom
  • Yeovil District Hospital
    Yeovil, England BA21 4AT, United Kingdom
  • Gartnavel General Hospital
    Glasgow, Scotland G12 0YN, United Kingdom
  • Bronglais District General Hospital
    Aberystwyth, Wales SY23 1ER, United Kingdom
  • Velindre Cancer Center at Velindre Hospital
    Cardiff, Wales CF14 2TL, United Kingdom
  • South West Wales Cancer Institute
    Swansea, Wales SA2 8QA, United Kingdom
08

References and documents

Publications

  • 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. PubMed 24366937 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00263822
Lead sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Responsible party
Sponsor
First posted
Dec 9, 2005
Start date
Sep 2005
Primary completion
Feb 2008
Last update
Aug 27, 2013

Study contacts

Antonio Jimeno
study chair · Hospital Universitario 12 de Octubre
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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