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

Ovarian Cancer Clinical Trial

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

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. 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

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

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