Clinical trial NCT00263822: Erlotinib or Observation in Treating Patients Who Have Undergone First-Line Chemotherapy for Ovarian Cancer, Peritoneal Cancer, or Fallopian Tube Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2005-12-09
Enrollment: 835
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression-free survival
Secondary outcomes:
measure: Overall survival
measure: Adverse event profile
measure: Quality of life
measure: Cutaneous toxicity (rash or acne [papulo-pustular rash])
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: Prince of Wales Private Hospital
state: New South Wales
city: Tamworth
country: Australia
facility: Tamworth Base Hospital
state: New South Wales
city: Taree
country: Australia
facility: Manning Base Hospital
state: New South Wales
city: Waratah
country: Australia
facility: Newcastle Mater Misericordiae Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Carlton
country: Australia
facility: Royal Women's Hospital
state: Victoria
city: Frankston
country: Australia
facility: Frankston Hospital
state: Victoria
city: Wodonga
country: Australia
facility: Murray Valley Private Hospital and Cancer Treatment Centre
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital - Nedlands
state: Western Australia
city: Klagenfurt
country: Austria
facility: Landeskrankenhaus Klagenfurt
city: Kufstein
country: Austria
facility: A.o. Bezirkskrankenhaus Kufstein
city: Amilly
country: France
facility: Centre Hospitalier de L' Agglomeration Montargoise
city: Amilly
country: France
facility: Centre Hospitalier General
city: Aulnay Sous Bois
country: France
facility: Centre Hospital General Robert Ballanger
city: Besancon
country: France
facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
city: Bordeaux
country: France
facility: Institut Bergonie
city: Bordeaux
country: France
facility: Clinique Tivoli
city: Boucher
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Caen
country: France
facility: Centre Regional Francois Baclesse
city: Chambery
country: France
facility: Centre Hospitalier Regional de Chambery
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Colmar
country: France
facility: Hopital Louis Pasteur
city: Dax
country: France
facility: Centre Hospitalier de Dax
city: Evreux
country: France
facility: Clinique Pasteur
city: Gap
country: France
facility: Centre Hospitalier de Gap
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier Departemental
city: Le Mans
country: France
facility: Clinique Victor Hugo
city: Lorient
country: France
facility: Centre Hospitalier Bretagne Sud
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Hopital Saint Joseph
city: Mont-de-Marsan
country: France
facility: Centre Hospitalier General de Mont de Marsan
city: Montbeliard
country: France
facility: Centre Hospitalier General Andre Boulloche
city: Montlucon
country: France
facility: Centre Hospitalier de Montlucon
city: Montpellier
country: France
facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
city: Paris
country: France
facility: Hotel Dieu de Paris
city: Paris
country: France
facility: Institut Curie Hopital
city: Perigueux
country: France
facility: Polyclinique Francheville
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers
country: France
facility: CHU Poitiers
city: Reims
country: France
facility: Institut Jean Godinot
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Saint Brieuc
country: France
facility: Clinique Armoricaine De Radiologie
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Strasbourg
country: France
facility: Hopitaux Universitaire de Strasbourg
city: Tours
country: France
facility: Centre Hospitalier Universitaire Bretonneau de Tours
city: Valence
country: France
facility: Centre Hospitalier Valence
city: Vandoeuvre-les-Nancy
country: France
facility: Centre Alexis Vautrin
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico - Aviano
city: Como
country: Italy
facility: Ospedale Sant Anna
city: Latina
country: Italy
facility: Ospedale Santa Maria Goretti
city: Milan
country: Italy
facility: Ospedale Niguarda Ca'Granda
city: Monza
country: Italy
facility: Ospedale San Gerardo
city: Turin
country: Italy
facility: Universita di Torino
city: Turin
country: Italy
facility: Azienda Sanitaria Ospedaliera Ordine Mauriziano
city: Varese
country: Italy
facility: Ospedale di Circolo e Fondazione Macchi
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Nijmegen
country: Netherlands
facility: Universitair Medisch Centrum St. Radboud - Nijmegen
city: Rotterdam
country: Netherlands
facility: Erasmus MC - Sophia Children's Hospital
city: Coimbra
country: Portugal
facility: Hospitais da Universidade de Coimbra (HUC)
city: Barcelona
country: Spain
facility: Institut d'Oncologia Corachan
city: Madrid
country: Spain
facility: Hospital Universitario San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Valencia
country: Spain
facility: Instituto Valenciano De Oncologia
city: Aylesbury-Buckinghamshire
country: United Kingdom
facility: Stoke Mandeville Hospital
state: England
city: Barnstaple
country: United Kingdom
facility: North Devon District Hospital
state: England
city: Bath
country: United Kingdom
facility: Royal United Hospital
state: England
city: Birmingham
country: United Kingdom
facility: City Hospital - Birmingham
state: England
city: Carlisle
country: United Kingdom
facility: Cumberland Infirmary
state: England
city: Gateshead
country: United Kingdom
facility: Queen Elizabeth Hospital
state: England
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital
state: England
city: London
country: United Kingdom
facility: University College Hospital
state: England
city: Maidstone
country: United Kingdom
facility: Mid Kent Oncology Centre at Maidstone Hospital
state: England
city: Margate
country: United Kingdom
facility: Queen Elizabeth The Queen Mother Hospital
state: England
city: Merseyside
country: United Kingdom
facility: Clatterbridge Centre for Oncology
state: England
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
state: England
city: Newport
country: United Kingdom
facility: St. Mary's Hospital
state: England
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre at Mount Vernon Hospital
state: England
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
state: England
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
state: England
city: Shrewsbury
country: United Kingdom
facility: Royal Shrewsbury Hospital
state: England
city: Slough, Berkshire
country: United Kingdom
facility: Wexham Park Hospital
state: England
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: England
city: Stafford
country: United Kingdom
facility: Staffordshire General Hospital
state: England
city: Yeovil
country: United Kingdom
facility: Yeovil District Hospital
state: England
city: Glasgow
country: United Kingdom
facility: Gartnavel General Hospital
state: Scotland
city: Aberystwyth
country: United Kingdom
facility: Bronglais District General Hospital
state: Wales
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Center at Velindre Hospital
state: Wales
city: Swansea
country: United Kingdom
facility: South West Wales Cancer Institute
state: Wales
Study officials:
affiliation: Hospital Universitario 12 de Octubre
name: Antonio Jimeno
role: STUDY_CHAIR
References:
citation: 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.