AzTrials
AzTrials

Pancreatic CancerPhase 3NCT00040183

OSI-774 (Tarceva) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer.

A Phase 3 study testing Tarceva (erlotinib HCl, OSI-774) in people with Pancreatic Cancer, run by OSI Pharmaceuticals at 140 sites in 17 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

The purpose of this study is to determine if OSI-774 will improve overall survival when combined with a standard dose of the chemotherapy drug gemcitabine, to individuals with pancreatic cancer. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
Tarceva (erlotinib HCl, OSI-774)
How many people
569 participants
Where
140 sitesin 17 countries
Study dates
29 Nov 2001to 15 Jan 2004
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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas;cancer which is unresectable, locally advanced or metastatic.
  • Must have evidence of disease (clinical or radiological). Male or female, 18 years or older. Patients may have received prior radiation treatment for management of local disease providing that disease progression has been documented.
  • All toxicities have resolved, and the last fraction of radiation treatment was completed at least 4 weeks prior to randomization.
  • Patients may not have received prior chemotherapy, other then 5FU (+/- folic acid) or gemcitabine given concurrently with radiation treatment as a 'radiosensitiser.'

Who cannot join

None listed.

Trial locations and contacts

140 sites in 17 countries.

140 sites in 17 countries

United States60 sites

  • Annapolis Medical Specialists

    Annapolis, Maryland, 21401

  • Arlington Cancer Centre

    Arlington, Texas, 76012

  • Atlanta Cancer Center

    Atlanta, Georgia, 30342

  • Southwest Regional Cancer Center

    Austin, Texas, 78705

  • Sinai Hospital

    Baltimore, Maryland, 21215

  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Green Mountain Oncology Group

    Bennington, Vermont, 05201

  • Alta Bates Comprehensive Cancer Center

    Berkeley, California, 94704

  • Odyssey Research Services

    Bismarck, North Dakota, 58501

  • St Elizabeth Medical Center

    Boston, Massachusetts, 01235

  • New England Medical Center

    Boston, Massachusetts, 02111

  • Charleston Hematology/Oncology

    Charleston, South Carolina, 29403

  • Presbyterian Hospital

    Charlotte, North Carolina, 28204

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106-7832

  • Hematology & Oncolgy Assoc of NE PA

    Dunmore, Pennsylvania, 18512

  • Florida Cancer Specialists

    Fort Myers, Florida, 34135-4251

  • Arena Oncology Associates

    Great Neck, New York, 11021

  • New Hampshire Oncology-Hematology PA

    Hooksett, New Hampshire, 03106

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Iowa Hospital & Clinics

    Iowa City, Iowa, 52242

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Kansas City Oncology and Hematology Group

    Kansas City, Missouri, 64111

  • University of Kentucky

    Lexington, Kentucky, 40536-0098

  • St Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Loma Linda University Cancer Institute

    Loma Linda, California, 92354

  • Metropolitan Hematology/Oncology Medical Group, Inc.

    Los Angeles, California, 90057

  • UCLA Medical Center

    Los Angeles, California, 90095

  • Norton Healthcare, Inc.

    Louisville, Kentucky, 40202

  • DeQuattro Community Cancer Center

    Manchester, Connecticut, 06040

  • J Gurtler, Hematology and Oncology

    Metairie, Louisiana, 70006

  • Oncology Hematology Group of South Florida

    Miami, Florida, 33176

  • Oncology of Wisconsin

    Milwaukee, Wisconsin, 53215

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Sarah Cannon Cancer Center

    Nashville, Tennessee, 37203

  • New Britain General Hospital

    New Britain, Connecticut, 06050

  • New York University School of Medicine

    New York, New York, 10016

  • St Luke's-Roosevelt Hospital

    New York, New York, 10019

  • Eastern Connecticut Oncology

    Norwich, Connecticut, 06360-2910

  • Ocala Oncology

    Ocala, Florida, 34474

  • Western Washington Oncology Inc.

    Olympia, Washington, 98502

  • Onc/Hem Associates of Central Illinois

    Peoria, Illinois, 61602

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Pennsylvania Oncology Hematology Associates

    Philadelphia, Pennsylvania, 19106

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Berkshire Hematology & Oncology, PC

    Pittsfield, Massachusetts, 012018298

  • Chiles Research Cancer Center

    Portland, Oregon, 97213-2967

  • Hematology & Oncology Associates of Virginia, Ltd.

    Richmond, Virginia, 23226

  • Interlakes Oncology & Hematology, P.C.

    Rochester, New York, 14623

  • Kaiser Permanente

    San Diego, California, 92120

  • Hematology Oncology Associates of Illinois

    Skokie, Illinois, 60077

  • Highlands Oncology Group

    Springdale, Arkansas, 72764

  • Baystate Medical Center

    Springfield, Massachusetts, 01107

  • Carl and Dorothy Bennett Cancer Center

    Stamford, Connecticut, 06902-3628

  • Stony Brook University Hospital

    Stony Brook, New York, 11794-8174

  • Tampa General Hospital

    Tampa, Florida, 33606

  • Arizona Clinical Research Center

    Tucson, Arizona, 85715

  • Tyler Hematology Oncology PA

    Tyler, Texas, 75701

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Southwest Washington Medical Center

    Vancouver, Washington, 98664

Other trials in United States

Canada25 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • Hamilton Regional Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • BC Cancer Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • Kingston Regional Cancer Centre

    Kingston, Ontario, K7L 5P9

  • London Regional Cancer Center

    London, Ontario, N6A 4L6

  • Credit Valley Hospital

    Mississauga, Ontario, L5M 2V8

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • Hopital Du Sacre-Coeur

    Montreal, Quebec, H4J 2C5

  • Ottawa Regional Cancer Centre

    Ottawa, Ontario, K1H 1C4

  • Pentincton Regional Hospital

    Pentincton, British Columbia, V2A 3G6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Group Health Centre

    Saulte Ste. Marie, Ontario, P6B 1Y5

  • Hotel Dieu Health Sciences HospitalNiagra

    St. Catharines, Ontario, L2R 5K3

  • Dr. H. Bliss Murphy Cancer Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Hopital Laval

    Ste-Foy, Quebec, G1V 4G5

  • Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2

  • Toronto East General Hospital

    Toronto, Ontario, M4C 3E7

  • Toronto-Sunnybrook Regional Cancer Center

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • St Joseph's Health Centre

    Toronto, Ontario, M6R 1B5

  • BCCA VAncouver Centre

    Vancouver, British Columbia, V5Z 4E6

  • BCCA- Vancouver Island Centre

    Victoria, British Columbia, V8R 6V5

  • CancerCare Manitoba (CCMB)

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

United Kingdom9 sites

  • Velindre Hospital

    Cardiff, Wales, CF14 2TL

  • Russell's Hall HospitalDepartment of OncologyGeorgina Unit

    Dudley, West Midlands, DY8 5QX

  • The Princess Royal Hospital

    Hull, HU8 9HE

  • St. Bartholomews Hospital

    London, EC1A 7BE

  • North Middlesex Hospital

    London, N18 1QX

  • Department of Medical Oncology

    Manchester, M20 4BX

  • Newcastle General Hospital

    Newcastle upon Tyne, NE4 6BE

  • ICRF Medical Oncology Unit

    Oxford, Oxfordshire, OX3 7LJ

  • Deanesly Centre

    Wolverhampton, West Midlands, WV10 0QP

Other trials in United Kingdom

Australia8 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Ashford Cancer Centre

    Ashford, South Australia, 5035

  • Concord Hospital

    Concord, New South Wales, 2139

  • Frankston Hospital

    Frankston, Victoria, 3199

  • Austin & Repatriation Medical Centre

    Heidelberg, Victoria, 3084

  • Newcastle Mater Hospital

    HRMC Waratah, New South Wales, 2310

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011

Other trials in Australia

Germany7 sites

  • Charite Campus Virchow Klinikum

    Berlin, 13353

  • Universitatsklinikum Essen

    Essen, 45122

  • Tumor Biology Center

    Freiburg im Breisgau, D-79106

  • Universitatskliniken des Saarlands Innere Medizin II

    Hamburg, 66421

  • Innere MedizinUniversitatsklinikum Heidelberg

    Heidelberg

  • Universitatskliniken des Saarlands

    Homburg, 66421

  • Medizinische Poliklinik der Universitaet Wurzburg

    Würzburg, 97070

Other trials in Germany

Argentina6 sites

  • Hospital Italiano de Buenos Aires

    Buenos Aires, CP 1181

  • Hospital Britanico

    Buenos Aires, CP 1280

  • Instituto Oncologico Angel Roffo

    Buenos Aires, CP 1417

  • Instituto Alexander Fleming

    Buenos Aires, CP 1426

  • Hospital Churruca Visca

    Buenos Aires, CP 1437

  • Centro Medico Confidence

    Buenos Aires, CP 1642

Other trials in Argentina

Israel5 sites

  • Rambam Medical Center

    Haifa, 31096

  • Rabin Medical Center (Belinson Campus)

    Petach Tiqva, 49100

  • Kaplan Medical Center

    Rehovot

  • Sourasky Medical Center (Ichikov)

    Tel Aviv, 64239

  • Chaim Sheba Medical Center

    Tel HaShomer, 52621

Other trials in Israel

Brazil4 sites

  • Hospital Vera Cruz S/A

    Barro Preto, Minas Gerais, CEP 30190-130

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, CEP 90020-090

  • Nucleo de Oncolgia da Bahia

    Salvador, Estado de Bahia, 40170-070

  • Hospital Israelita Albert Einstein

    São Paulo, São Paulo, 05651-901

Other trials in Brazil

Romania3 sites

  • Oncology Institute Ion Chiricuta

    Cluj-Napoca, 3400

  • St. Spiridon University Hospital

    Iași, 6600

  • Clinical County Hospital Sibiu

    Sibiu, 2400

Other trials in Romania

Singapore3 sites

  • National University Hospital

    Singapore, 119074

  • Singapore General Hospital

    Singapore, 169608

  • National Cancer Centre

    Singapore, 169610

Other trials in Singapore

Greece2 sites

  • Anticancer Hospital of Thessaloniki "THEAGENIO"

    Thessaloniki, 546 39

  • District General Hospital of Thessaloniki "HIPPOKRATION"

    Thessaloniki, 546 39

Other trials in Greece

New Zealand2 sites

  • Auckland Hospital

    Auckland, 92019

  • Christchurch HospitalClinical Oncology Hospital

    Christchurch

Other trials in New Zealand

Poland2 sites

  • Great Poland Cancer Centre

    Poznan, 61 866

  • Dolnoslaskie Centrum Onkologii

    Wroclaw, 53-413

Other trials in Poland

Belgium1 site

  • Institute Jules Bordet

    Brussels

Other trials in Belgium

Chile1 site

  • Clinica Las Condes

    Las Condes

Other trials in Chile

Italy1 site

  • Azienda Ospedaliera Universitaria Policlinico A.O.V.P. Oncologia Medica

    Palermo, 90127

Other trials in Italy

Mexico1 site

  • Instituto Nacional De Cancerologia

    Mexico City, 14000

Other trials in Mexico

About this study

Official title: A Randomized Placebo Controlled Study of OSI-774 (Tarceva (TM)) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer

The purpose of this study is to determine if OSI-774 will improve overall survival when combined with a standard dose of the chemotherapy drug gemcitabine, to individuals with pancreatic cancer.

Being tested
Tarceva (erlotinib HCl, OSI-774)
Keywords
Tarceva, EGFR, erlotinib, OSI-774
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • Tarceva (erlotinib HCl, OSI-774)Drug

Timeline

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

  1. First posted25 Jun 2002 (estimated)
  2. Study start29 Nov 2001
  3. Primary completion15 Jan 2004
  4. Study completion15 Jan 2004

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
Intervention model
Parallel groups
Masking
Double blind
Enrolment
569 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00040183
Sponsor's protocol ID
PA.3
Status last verified
Jun 2015
First submitted
21 Jun 2002
Last updated
10 Jan 2018
Results posted
No

Publications

  • Moore MJ, Goldstein D, Hamm J, Figer A, Hecht JR, Gallinger S, Au HJ, Murawa P, Walde D, Wolff RA, Campos D, Lim R, Ding K, Clark G, Voskoglou-Nomikos T, Ptasynski M, Parulekar W; National Cancer Institute of Canada Clinical Trials Group. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007 May 20;25(15):1960-6. doi: 10.1200/JCO.2006.07.9525. Epub 2007 Apr 23.

    PubMed 17452677

  • Shultz DB, Pai J, Chiu W, Ng K, Hellendag MG, Heestand G, Chang DT, Tu D, Moore MJ, Parulekar WR, Koong AC. A Novel Biomarker Panel Examining Response to Gemcitabine with or without Erlotinib for Pancreatic Cancer Therapy in NCIC Clinical Trials Group PA.3. PLoS One. 2016 Jan 25;11(1):e0147995. doi: 10.1371/journal.pone.0147995. eCollection 2016.

    PubMed 26808546

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tarceva (erlotinib HCl, OSI-774) in people with Pancreatic Cancer, run by OSI Pharmaceuticals at 140 sites in 17 countries.

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

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. 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 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in United States, Canada, United Kingdom, Australia, Germany and 12 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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00040183, which also lists 2 linked publications.

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 10 Jan 2018.

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