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

NCT00263822 | Completed Phase 3

• 2 other identifiers: EORTC-55041EUDRACT-2004-004333-34
• Study Type: interventional
• Target: 835
• Locations: 7 countries
• Sites: 83

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.

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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

Secondary Outcomes (4)

• Overall survival

• Adverse event profile

• Quality of life

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

Interventions

erlotinib hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (92)

Prince of Wales Private Hospital

Randwick, New South Wales, 2031, Australia

Location

Tamworth Base Hospital

Tamworth, New South Wales, 2340, Australia

Location

Manning Base Hospital

Taree, New South Wales, 2430, Australia

Location

Newcastle Mater Misericordiae Hospital

Waratah, New South Wales, 2298, Australia

Location

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia

Location

Royal Women's Hospital

Carlton, Victoria, 3053, Australia

Location

Frankston Hospital

Frankston, Victoria, 3199, Australia

Location

Murray Valley Private Hospital and Cancer Treatment Centre

Wodonga, Victoria, 3690, Australia

Location

Sir Charles Gairdner Hospital - Nedlands

Nedlands, Western Australia, 6009, Australia

Location

Landeskrankenhaus Klagenfurt

Klagenfurt, 9026, Austria

Location

A.o. Bezirkskrankenhaus Kufstein

Kufstein, 6330, Austria

Location

Centre Hospitalier de L' Agglomeration Montargoise

Amilly, 45207, France

Location

Centre Hospitalier General

Amilly, 45207, France

Location

Centre Hospital General Robert Ballanger

Aulnay-sous-Bois, 93602, France

Location

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

Besançon, 25030, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Clinique Tivoli

Bordeaux, F-33000, France

Location

Polyclinique Bordeaux Nord Aquitaine

Boucher, 33300, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Centre Hospitalier Regional de Chambery

Chambéry, 73011, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Hopital Louis Pasteur

Colmar, 68024, France

Location

Centre Hospitalier de Dax

Dax, 40107, France

Location

Clinique Pasteur

Évreux, 27000, France

Location

Centre Hospitalier de Gap

Gap, 05007, France

Location

Centre Hospitalier Departemental

La Roche-sur-Yon, F-85025, France

Location

Clinique Victor Hugo

Le Mans, F-72000, France

Location

Centre Hospitalier Bretagne Sud

Lorient, 56322, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Hopital Saint Joseph

Marseille, 13008, France

Location

Centre Hospitalier General de Mont de Marsan

Mont-de-Marsan, 40000, France

Location

Centre Hospitalier General Andre Boulloche

Montbéliard, 25209, France

Location

Centre Hospitalier de Montlucon

Montluçon, 03109, France

Location

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

Montpellier, 34298, France

Location

Hotel Dieu de Paris

Paris, 75181, France

Location

Institut Curie Hopital

Paris, 75248, France

Location

Polyclinique Francheville

Périgueux, 24004, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

CHU Poitiers

Poitiers, 86021, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Clinique Armoricaine De Radiologie

Saint-Brieuc, F-22015, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Hopitaux Universitaire de Strasbourg

Strasbourg, 67091, France

Location

Centre Hospitalier Universitaire Bretonneau de Tours

Tours, 37044, France

Location

Centre Hospitalier Valence

Valence, 26000, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Centro di Riferimento Oncologico - Aviano

Aviano, 33081, Italy

Location

Ospedale Sant Anna

Como, 22100, Italy

Location

Ospedale Santa Maria Goretti

Latina, 04100, Italy

Location

Ospedale Niguarda Ca'Granda

Milan, 20162, Italy

Location

Ospedale San Gerardo

Monza, 20052, Italy

Location

Universita di Torino

Turin, 10126, Italy

Location

Azienda Sanitaria Ospedaliera Ordine Mauriziano

Turin, 10128, Italy

Location

Ospedale di Circolo e Fondazione Macchi

Varese, 21100, Italy

Location

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, 1066 CX, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 HA, Netherlands

Location

Martini Ziekenhuis

Groningen, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

Location

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

Erasmus MC - Sophia Children's Hospital

Rotterdam, 3015 GJ, Netherlands

Location

Hospitais da Universidade de Coimbra (HUC)

Coimbra, 3049, Portugal

Location

Institut d'Oncologia Corachan

Barcelona, 08017, Spain

Location

Hospital Universitario San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33006, Spain

Location

Instituto Valenciano De Oncologia

Valencia, 46009, Spain

Location

Stoke Mandeville Hospital

Aylesbury-Buckinghamshire, England, HP21 8AL, United Kingdom

Location

North Devon District Hospital

Barnstaple, England, EX31 4JB, United Kingdom

Location

Royal United Hospital

Bath, England, BA1 3NG, United Kingdom

Location

City Hospital - Birmingham

Birmingham, England, B18 7QH, United Kingdom

Location

Cumberland Infirmary

Carlisle, England, CA2 7HY, United Kingdom

Location

Queen Elizabeth Hospital

Gateshead, England, NE9 6SX, United Kingdom

Location

Ipswich Hospital

Ipswich, England, IP4 5PD, United Kingdom

Location

University College Hospital

London, England, NW1 2BU, United Kingdom

Location

Mid Kent Oncology Centre at Maidstone Hospital

Maidstone, England, ME16 9QQ, United Kingdom

Location

Queen Elizabeth The Queen Mother Hospital

Margate, England, CT9 4AN, United Kingdom

Location

Clatterbridge Centre for Oncology

Merseyside, England, CH63 4JY, United Kingdom

Location

James Cook University Hospital

Middlesbrough, England, TS4 3BW, United Kingdom

Location

St. Mary's Hospital

Newport, England, PO30 5TG, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, England, NR4 7UY, United Kingdom

Location

Royal Preston Hospital

Preston, England, PR2 9HT, United Kingdom

Location

Royal Shrewsbury Hospital

Shrewsbury, England, SY3 8XQ, United Kingdom

Location

Wexham Park Hospital

Slough, Berkshire, England, SL2 4HL, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Staffordshire General Hospital

Stafford, England, ST16 3SA, United Kingdom

Location

Yeovil District Hospital

Yeovil, England, BA21 4AT, United Kingdom

Location

Gartnavel General Hospital

Glasgow, Scotland, G12 0YN, United Kingdom

Location

Bronglais District General Hospital

Aberystwyth, Wales, SY23 1ER, United Kingdom

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

South West Wales Cancer Institute

Swansea, Wales, SA2 8QA, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 24366937 DERIVED

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Antonio Jimeno

  Hospital Universitario 12 de Octubre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2005
• First Posted: December 9, 2005
• Study Start: September 1, 2005
• Primary Completion: February 1, 2008
• Last Updated: August 27, 2013

Record last verified: 2013-08

Locations

ES (5); NL (6); AU (2); FR (36); IT (8); PT (1); GB (25)