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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00263822
Other study ID # EORTC-55041
Secondary ID EORTC-55041EUDRA
Status Completed
Phase Phase 3
First received December 7, 2005
Last updated August 26, 2013
Start date September 2005

Study information

Verified date August 2013
Source European Organisation for Research and Treatment of Cancer - EORTC
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 835
Est. completion date
Est. primary completion date February 2008
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
erlotinib hydrochloride


Locations

Country Name City State
Australia Royal Brisbane and Women's Hospital Brisbane Queensland
Australia Royal Women's Hospital Carlton Victoria
Australia Frankston Hospital Frankston Victoria
Australia Sir Charles Gairdner Hospital - Nedlands Nedlands Western Australia
Australia 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 Murray Valley Private Hospital and Cancer Treatment Centre Wodonga Victoria
Austria Landeskrankenhaus Klagenfurt Klagenfurt
Austria A.o. Bezirkskrankenhaus Kufstein Kufstein
France 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 Besancon
France Clinique Tivoli Bordeaux
France Institut Bergonie Bordeaux
France Polyclinique Bordeaux Nord Aquitaine Boucher
France Centre Regional Francois Baclesse Caen
France Centre Hospitalier Regional de Chambery Chambery
France Centre Jean Perrin Clermont-Ferrand
France Hopital Louis Pasteur Colmar
France Centre Hospitalier de Dax Dax
France Clinique Pasteur Evreux
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 Montbeliard
France Centre Hospitalier de Montlucon Montlucon
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 Perigueux
France Centre Hospitalier Lyon Sud Pierre Benite
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 Vandoeuvre-les-Nancy
Italy 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 Azienda Sanitaria Ospedaliera Ordine Mauriziano Turin
Italy Universita di Torino Turin
Italy Ospedale di Circolo e Fondazione Macchi Varese
Netherlands 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
Portugal Hospitais da Universidade de Coimbra (HUC) Coimbra
Spain Institut d'Oncologia Corachan Barcelona
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario San Carlos Madrid
Spain Hospital Universitario Central de Asturias Oviedo
Spain Instituto Valenciano De Oncologia Valencia
United Kingdom Bronglais District General Hospital Aberystwyth Wales
United Kingdom 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 Velindre Cancer Center at Velindre Hospital Cardiff Wales
United Kingdom Cumberland Infirmary Carlisle England
United Kingdom Queen Elizabeth Hospital Gateshead England
United Kingdom Gartnavel General Hospital Glasgow Scotland
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 South West Wales Cancer Institute Swansea Wales
United Kingdom Yeovil District Hospital Yeovil England

Sponsors (1)

Lead Sponsor Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Australia,  Austria,  France,  Italy,  Netherlands,  Portugal,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free survival No
Secondary Overall survival No
Secondary Adverse event profile Yes
Secondary Quality of life No
Secondary Cutaneous toxicity (rash or acne [papulo-pustular rash]) Yes
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