AzTrials
AzTrials

Fallopian Tube CancerPhase 3NCT00263822

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

A Phase 3 study testing erlotinib hydrochloride in people with Fallopian Tube Cancer and Ovarian Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 92 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
erlotinib hydrochloride
How many people
835 participants
Where
92 sitesin 8 countries
Study dates
Sep 2005to Feb 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

92 sites in 8 countries.

92 sites in 8 countries

France36 sites

  • Centre Hospitalier de L' Agglomeration Montargoise

    Amilly, 45207

  • Centre Hospitalier General

    Amilly, 45207

  • Centre Hospital General Robert Ballanger

    Aulnay-sous-Bois, 93602

  • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • Institut Bergonie

    Bordeaux, 33076

  • Clinique Tivoli

    Bordeaux, F-33000

  • Polyclinique Bordeaux Nord Aquitaine

    Boucher, 33300

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Centre Hospitalier Regional de Chambery

    Chambéry, 73011

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Hopital Louis Pasteur

    Colmar, 68024

  • Centre Hospitalier de Dax

    Dax, 40107

  • Clinique Pasteur

    Évreux, 27000

  • Centre Hospitalier de Gap

    Gap, 05007

  • Centre Hospitalier Departemental

    La Roche-sur-Yon, F-85025

  • Clinique Victor Hugo

    Le Mans, F-72000

  • Centre Hospitalier Bretagne Sud

    Lorient, 56322

  • Centre Leon Berard

    Lyon, 69373

  • Hopital Saint Joseph

    Marseille, 13008

  • Centre Hospitalier General de Mont de Marsan

    Mont-de-Marsan, 40000

  • Centre Hospitalier General Andre Boulloche

    Montbéliard, 25209

  • Centre Hospitalier de Montlucon

    Montluçon, 03109

  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

    Montpellier, 34298

  • Hotel Dieu de Paris

    Paris, 75181

  • Institut Curie Hopital

    Paris, 75248

  • Polyclinique Francheville

    Périgueux, 24004

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHU Poitiers

    Poitiers, 86021

  • Institut Jean Godinot

    Reims, 51056

  • Centre Eugene Marquis

    Rennes, 35042

  • Clinique Armoricaine De Radiologie

    Saint-Brieuc, F-22015

  • Centre Paul Strauss

    Strasbourg, 67065

  • Hopitaux Universitaire de Strasbourg

    Strasbourg, 67091

  • Centre Hospitalier Universitaire Bretonneau de Tours

    Tours, 37044

  • Centre Hospitalier Valence

    Valence, 26000

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

Other trials in France

United Kingdom25 sites

  • Bronglais District General Hospital

    Aberystwyth, Wales, SY23 1ER

  • Stoke Mandeville Hospital

    Aylesbury-Buckinghamshire, England, HP21 8AL

  • North Devon District Hospital

    Barnstaple, England, EX31 4JB

  • Royal United Hospital

    Bath, England, BA1 3NG

  • City Hospital - Birmingham

    Birmingham, England, B18 7QH

  • Velindre Cancer Center at Velindre Hospital

    Cardiff, Wales, CF14 2TL

  • Cumberland Infirmary

    Carlisle, England, CA2 7HY

  • Queen Elizabeth Hospital

    Gateshead, England, NE9 6SX

  • Gartnavel General Hospital

    Glasgow, Scotland, G12 0YN

  • Ipswich Hospital

    Ipswich, England, IP4 5PD

  • University College Hospital

    London, England, NW1 2BU

  • Mid Kent Oncology Centre at Maidstone Hospital

    Maidstone, England, ME16 9QQ

  • Queen Elizabeth The Queen Mother Hospital

    Margate, England, CT9 4AN

  • Clatterbridge Centre for Oncology

    Merseyside, England, CH63 4JY

  • James Cook University Hospital

    Middlesbrough, England, TS4 3BW

  • St. Mary's Hospital

    Newport, England, PO30 5TG

  • Mount Vernon Cancer Centre at Mount Vernon Hospital

    Northwood, England, HA6 2RN

  • Norfolk and Norwich University Hospital

    Norwich, England, NR4 7UY

  • Royal Preston Hospital

    Preston, England, PR2 9HT

  • Royal Shrewsbury Hospital

    Shrewsbury, England, SY3 8XQ

  • Wexham Park Hospital

    Slough, Berkshire, England, SL2 4HL

  • Southampton General Hospital

    Southampton, England, SO16 6YD

  • Staffordshire General Hospital

    Stafford, England, ST16 3SA

  • South West Wales Cancer Institute

    Swansea, Wales, SA2 8QA

  • Yeovil District Hospital

    Yeovil, England, BA21 4AT

Other trials in United Kingdom

Australia9 sites

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland, 4029

  • Royal Women's Hospital

    Carlton, Victoria, 3053

  • Frankston Hospital

    Frankston, Victoria, 3199

  • Sir Charles Gairdner Hospital - Nedlands

    Nedlands, Western Australia, 6009

  • Prince of Wales Private Hospital

    Randwick, New South Wales, 2031

  • Tamworth Base Hospital

    Tamworth, New South Wales, 2340

  • Manning Base Hospital

    Taree, New South Wales, 2430

  • Newcastle Mater Misericordiae Hospital

    Waratah, New South Wales, 2298

  • Murray Valley Private Hospital and Cancer Treatment Centre

    Wodonga, Victoria, 3690

Other trials in Australia

Italy8 sites

  • Centro di Riferimento Oncologico - Aviano

    Aviano, 33081

  • Ospedale Sant Anna

    Como, 22100

  • Ospedale Santa Maria Goretti

    Latina, 04100

  • Ospedale Niguarda Ca'Granda

    Milan, 20162

  • Ospedale San Gerardo

    Monza, 20052

  • Universita di Torino

    Turin, 10126

  • Azienda Sanitaria Ospedaliera Ordine Mauriziano

    Turin, 10128

  • Ospedale di Circolo e Fondazione Macchi

    Varese, 21100

Other trials in Italy

Netherlands6 sites

  • Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

    Amsterdam, 1066 CX

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 HA

  • Martini Ziekenhuis

    Groningen

  • Leiden University Medical Center

    Leiden, 2300 RC

  • Universitair Medisch Centrum St. Radboud - Nijmegen

    Nijmegen, NL-6500 HB

  • Erasmus MC - Sophia Children's Hospital

    Rotterdam, 3015 GJ

Other trials in Netherlands

Spain5 sites

  • Institut d'Oncologia Corachan

    Barcelona, 08017

  • Hospital Universitario San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Central de Asturias

    Oviedo, 33006

  • Instituto Valenciano De Oncologia

    Valencia, 46009

Other trials in Spain

Austria2 sites

  • Landeskrankenhaus Klagenfurt

    Klagenfurt, 9026

  • A.o. Bezirkskrankenhaus Kufstein

    Kufstein, 6330

Other trials in Austria

Portugal1 site

  • Hospitais da Universidade de Coimbra (HUC)

    Coimbra, 3049

Other trials in Portugal

About this study

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

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.

Being tested
erlotinib hydrochloride
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
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • erlotinib hydrochlorideDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

Secondary outcomes (4)

  1. Overall survival

  2. Adverse event profile

  3. Quality of life

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2005 (estimated)
  2. Study startSep 2005
  3. Primary completionFeb 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
Enrolment
835 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00263822
Sponsor's protocol ID
EORTC-55041
Other IDs
EORTC-55041, EUDRACT-2004-004333-34
Status last verified
Aug 2013
First submitted
7 Dec 2005
Last updated
27 Aug 2013
Results posted
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing erlotinib hydrochloride in people with Fallopian Tube Cancer and Ovarian Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 92 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in France, United Kingdom, Australia, Italy, Netherlands and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00263822, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in