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Pancreatic CancerPhase 3NCT00026338

Gemcitabine With/Out Erlotinib in Unresectable Locally Advanced/Metastatic Pancreatic Cancer

A Phase 3 study testing erlotinib hydrochloride and gemcitabine hydrochloride in people with Pancreatic Cancer, run by NCIC Clinical Trials Group at 173 sites in 19 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as erlotinib use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy and biological therapy may kill more tumor cells. 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?
erlotinib hydrochloride and gemcitabine hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
569 participants
Where
173 sitesin 19 countries
Study dates
29 Oct 2001to 10 Feb 2009
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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the pancreas
  • Locally advanced or metastatic disease that is considered unresectable
  • No known CNS metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin less than 2 times upper limit of normal (ULN)
  • AST and/or ALT less than 2 times ULN (5 times ULN if liver metastases present)

Renal:

  • Creatinine less than 1.5 times ULN

Cardiovascular:

  • No uncontrolled high blood pressure
  • No unstable angina
  • No congestive heart failure
  • No myocardial infarction within the past year
  • No cardiac ventricular arrhythmias requiring medication

Gastrointestinal:

  • No gastrointestinal (GI) tract disease resulting in an inability to take oral medication such as uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
  • No post-surgical malabsorption characterized by:
  • Uncontrolled diarrhea that results in weight loss and vitamin deficiency OR
  • Requires IV hyperalimentation
  • Pancreatic enzyme supplementation allowed provided that the above criteria are not met

Ophthalmic:

  • No ocular inflammation or infection unless fully treated prior to study
  • No significant ophthalmologic abnormalities, including the following:
  • Severe dry eye syndrome
  • Sjogren's syndrome
  • Keratoconjunctivitis sicca
  • Severe exposure keratopathy
  • Disorders that would increase the risk for epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis)

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No serious active infection
  • No other serious underlying medical, psychological, or geographical condition that would preclude study participation
  • No prior allergic reaction to compounds with similar chemical or biologic composition to erlotinib
  • No other prior malignancy within the past 5 years except cancer in situ or basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent biologic therapy or immunotherapy

Chemotherapy:

  • No prior chemotherapy except fluorouracil (with or without leucovorin calcium) or gemcitabine administered concurrently with radiotherapy as a radiosensitizer
  • No other concurrent cytotoxic chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Chemotherapy
  • At least 4 weeks since prior radiotherapy and recovered
  • Prior radiotherapy for local disease allowed if evidence of disease progression has occurred
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics
  • At least 2 weeks since prior major surgery
  • No concurrent ophthalmic surgery

Other:

  • No prior epidermal growth factor receptor inhibitors
  • At least 2 weeks since prior investigational drug
  • No other concurrent investigational drugs during and for at least 30 days after study
  • No other concurrent anti-cancer therapy

Trial locations and contacts

173 sites in 19 countries.

173 sites in 19 countries

United States74 sites

  • Annapolis Medical Specialists

    Annapolis, Maryland, 21401

  • Arlington Cancer Center

    Arlington, Texas, 76012

  • Northwest Medical Specialists, P.C.

    Arlington Heights, Illinois, 60004

  • Southwest Regional Cancer Center

    Austin, Texas, 78705

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • 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

  • Mid Dakota Clinic, P.C.

    Bismarck, North Dakota, 58502-5538

  • Mountain States Tumor Institute

    Boise, Idaho, 83712

  • Tuft-New England Medical Center

    Boston, Massachusetts, 02111

  • St. Elizabeth's Medical Center

    Boston, Massachusetts, 02135-2997

  • Charleston Hematology-Oncology, P.A.

    Charleston, South Carolina, 29403

  • Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Hematology-Oncology Association of NE Pennsylvania

    Dunmore, Pennsylvania, 18512

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Texas Cancer Care

    Fort Worth, Texas, 76104

  • Oncology of Wisconsin

    Glendale, Wisconsin, 53212

  • Cancer Center at Glens Falls Hospital

    Glens Falls, New York, 12801

  • Arena Oncology Associates

    Great Neck, New York, 11021

  • Sutter Health West Cancer Research Group

    Greenbrae, California, 94904

  • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)

    Hines, Illinois, 60141

  • New Hampshire Oncology-Hematology PA

    Hooksett, New Hampshire, 03106

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160-7353

  • Midwest Oncology Consortium

    Kansas City, Missouri, 64111

  • Lucille Parker Markey Cancer Center, University of Kentucky

    Lexington, Kentucky, 40536-0093

  • St. Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Loma Linda University Cancer Institute

    Loma Linda, California, 92354

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90033-0804

  • Kenmar Research Institute

    Los Angeles, California, 90057

  • Century City Hospital

    Los Angeles, California, 90067

  • David Geffen School of Medicine

    Los Angeles, California, 90095-7059

  • Norton Healthcare Pavilion

    Louisville, Kentucky, 40202

  • Central Georgia Hematology Oncology, P.C.

    Macon, Georgia, 31201

  • Davis, Posteraro, & Wasser, MDs, LLP

    Manchester, Connecticut, 06040

  • Hematology & Oncology Associates of Virginia

    Mechanicsville, Virginia, 23116

  • Study site

    Metairie, Louisiana, 70006

  • Oncology-Hematology Group of South Florida

    Miami, Florida, 33176

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

  • Hematology-Oncology Associates

    Mount Holly, New Jersey, 08060

  • Medical Consultants

    Muncie, Indiana, 47304

  • Sarah Cannon-Minnie Pearl Cancer Center

    Nashville, Tennessee, 37203

  • New Britain General Hospital

    New Britain, Connecticut, 06050-2000

  • Tulane Cancer Center

    New Orleans, Louisiana, 70112-2699

  • NYU School of Medicine's Kaplan Comprehensive Cancer Center

    New York, New York, 10016

  • Beth Israel Medical Center

    New York, New York, 10019

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut, 06360

  • Ocala Oncology Center

    Ocala, Florida, 34471-5563

  • Western Washington Oncology

    Olympia, Washington, 98502

  • Oncology/Hematology Associates of Central Illinois, P.C.

    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 Physicians and Surgeons, P.C.

    Pittsfield, Massachusetts, 01201

  • Earle A. Chiles Research Institute at Providence Portland Medical Center

    Portland, Oregon, 97213-2967

  • Interlakes Oncology/Hematology PC

    Rochester, New York, 14623

  • Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego

    San Diego, California, 92120

  • Midwest Cancer Research Group, Inc.

    Skokie, Illinois, 60076

  • Highlands Oncology Group

    Springdale, Arkansas, 72764

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • Hematology Oncology, P.C.

    Stamford, Connecticut, 06902

  • Staten Island University Hospital

    Staten Island, New York, 10305

  • University Hospital - Stony Brook

    Stony Brook, New York, 11794-8174

  • Oncology & Hematology Associates of West Broward

    Tamarac, Florida, 33321

  • Moffitt Clinic at Tampa General Hospital

    Tampa, Florida, 33612-9497

  • Arizona Clinical Research Center

    Tucson, Arizona, 85712

  • Tyler Hematology Oncology, P.A.

    Tyler, Texas, 75701

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Southwest Washington Medical Center

    Vancouver, Washington, 98664

  • Cooper Cancer Institute

    Voorhees Township, New Jersey, 08043

Other trials in United States

Canada28 sites

  • Royal Victoria Hospital, Barrie

    Barrie, Ontario, L4M 6M2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Queen Elizabeth II Health Science Centre

    Halifax, Nova Scotia, B3H 2Y9

  • Cancer Care Ontario-Hamilton Regional Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • British Columbia Cancer Agency - Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • Kingston Regional Cancer Centre

    Kingston, Ontario, K7L 5P9

  • Cancer Care Ontario-London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Credit Valley Hospital

    Mississauga, Ontario, L5M 2N1

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4

  • Hopital Du Sacre-Coeur de Montreal

    Montreal, Quebec, H4J 1C5

  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2P9

  • Ottawa Regional Cancer Centre

    Ottawa, Ontario, K1H 1C4

  • Penticton Regional Hospital

    Penticton, British Columbia, V2A 3G6

  • Peterborough Oncology Clinic

    Peterborough, Ontario, K9H 7B6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Algoma District Medical Group

    Sault Ste. Marie, Ontario, P6B 1Y5

  • Hotel Dieu Health Sciences Hospital - Niagara

    St. Catharines, Ontario, L2R 5K3

  • Newfoundland Cancer Treatment and Research Foundation

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

  • L'Hopital Laval

    Ste-Foy, Quebec, G1V 4G5

  • British Columbia Cancer Agency - Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2

  • Toronto East General Hospital

    Toronto, Ontario, M4C 3E7

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Ontario Cancer Institute

    Toronto, Ontario, M4X 1K9

  • Toronto General Hospital

    Toronto, Ontario, M4X 1K9

  • Saint Joseph's Health Centre - Toronto

    Toronto, Ontario, M6R 1B5

  • British Columbia Cancer Agency

    Victoria, British Columbia, V8R 6V5

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

United Kingdom13 sites

  • Belfast City Hospital Trust

    Belfast, Northern Ireland, BT9 7AB

  • Queen Elizabeth Hospital

    Birmingham, England, B18 7QH

  • Velindre Hospital

    Cardiff, Wales, CF4 7XL

  • North Middlesex Hospital

    Edmonton, London, England, NI8 1QX

  • St. Luke's Cancer Center

    Guildford, England, GU2 5XX

  • Princess Royal Hospital

    Hull, England, HU8 9HE

  • Saint Bartholomew's Hospital

    London, England, EC1A 7BE

  • Guy's and St. Thomas' Hospitals NHS Trust

    London, England, SE1 9RT

  • Christie Hospital N.H.S. Trust

    Manchester, England, M20 4BX

  • Northern Centre for Cancer Treatment

    Newcastle upon Tyne, England, NE4 6BE

  • Churchill Hospital

    Oxford, OX3 7LJ

  • Royal South Hants Hospital

    Southampton, England, SO14 0YG

  • New Cross Hospital

    Wolverhampton, England, WV10 0QP

Other trials in United Kingdom

Australia11 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Ashford Cancer Centre

    Ashford, South Australia, 5035

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Frankston Hospital

    Frankston, Victoria, 3199

  • Austin and Repatriation Medical Centre

    Heidelberg, Victoria, 3084

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Peter MacCallum Cancer Institute

    Melbourne, 8006

  • Newcastle Mater Misericordiae Hospital

    Newcastle, New South Wales, NSW 2310

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Institute of Oncology

    Randwick, New South Wales, 2031

  • Queen Elizabeth Hospital

    Woodville, South Australia, 5011

Other trials in Australia

Germany8 sites

  • Virchow Klinikum Humboldt Universitaet Berlin

    Berlin, D-13353

  • Universitaetsklinik und Strahlenklinik - Essen

    Essen, D-45122

  • Stadtische Kliniken Frankfurt-Hochst

    Frankfurt, DOH-65929

  • Tumor Biology Center at the Albert - Ludwigs University

    Freiburg im Breisgau, D-79106

  • Martin Luther Universitaet

    Halle, DOH-06112

  • Medizinische Universitaetsklinik und Poliklinik

    Heidelberg, D-69115

  • Universitatsklinik, Saarland

    Homburg/Saar, D-66421

  • University Wurzburg

    Würzburg, D-97070

Other trials in Germany

Argentina7 sites

  • Hospital Britanico

    Buenos Aires, 1280

  • Instituto de Oncologia Angel H. Roffo

    Buenos Aires, 1417

  • Instituto Alexander Fleming

    Buenos Aires, 1426

  • Hospital Churruca

    Buenos Aires, 1437

  • Hospital Italiano

    Buenos Aires, CP1181ACH

  • Hospital Interzonal De Augudos Euita

    Lanus, 1824

  • Confidence Medical Center

    San Isidro, 1642

Other trials in Argentina

Israel7 sites

  • Haemek Medical Center

    Afula, 18101

  • Rambam Medical Center

    Haifa, 31096

  • Rabin Medical Center - Beilinson Campus

    Petah Tikva, 49100

  • Rabin Medical Center - Golda-Hasharon Campus

    Petah Tikva, 49372

  • Kaplan Hospital

    Rehovot, 76100

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 64239

  • Sheba Medical Center

    Tel HaShomer, 52621

Other trials in Israel

Romania4 sites

  • Institute of Oncology - Bucarest

    Bucharest, RO 72435

  • Institutul Oncologic-Universitatea de Medicina

    Cluj-Napoca, 3400

  • St. Spiridon University Hospital

    Lasi, 6600

  • Clinical County Hospital of Sibiu

    Sibiu, 2400

Other trials in Romania

Brazil3 sites

  • Nucleo de Oncologia da Bahia

    Bahia, 40170-070

  • Hospital Santa Rita Irtmandade Santa Casa De Porto Alegre

    Porto Alegre, 91330-490

  • Hospital Israelita Albert Einstein

    São Paulo, 05651-901

Other trials in Brazil

Greece3 sites

  • University Hospital of Heraklion

    Iraklion (Heraklion), Crete, 71110

  • Theagenio Medical Institute

    Thessaloniki, 540 07

  • Hippokration Hospital

    Thessaloniki, 54642

Other trials in Greece

Singapore3 sites

  • National University Hospital

    Singapore, 119074

  • Singapore General Hospital

    Singapore, 168609

  • National Cancer Centre - Singapore

    Singapore, 169610

Other trials in Singapore

China2 sites

  • Pamela Youde Nethersole Eastern Hospital

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

Other trials in China

Mexico2 sites

  • Centro Estatal de Cancerologia

    Dviango, 34000

  • Instituto Nac de Cancerologia

    Tlalpan, Mexico City, 22

Other trials in Mexico

New Zealand2 sites

  • Auckland Hospital

    Auckland, 1

  • Christchurch Hospital

    Christchurch, 1

Other trials in New Zealand

Poland2 sites

  • Great Poland Cancer Center

    Poznan, 61 866

  • Dolnoslaskie Centrum Oncology

    Wroclaw, 53-413

Other trials in Poland

Belgium1 site

  • Institut Jules Bordet

    Brussels, 1000

Other trials in Belgium

Chile1 site

  • Clinica Las Condes

    Santiago

Other trials in Chile

Hong Kong1 site

  • Prince of Wales Hospital

    Shatin, New Territories, NT

Other trials in Hong Kong

Italy1 site

  • Policlinico - Cattedra di Ematologia

    Palermo, 90100

Other trials in Italy

About this study

Official title: A Randomized Placebo Controlled Study Of OSI-774 (TARCEVA) Plus Gemcitabine In Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as erlotinib use different ways to stimulate the immune system and stop cancer cells from growing. Combining chemotherapy and biological therapy may kill more tumor cells. It is not yet known if gemcitabine is more effective with or without erlotinib in treating pancreatic cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of gemcitabine with and without erlotinib in treating patients who have unresectable locally advanced or metastatic pancreatic cancer.

Read the detailed description

OBJECTIVES:

  • Compare the overall survival rate in patients with unresectable locally advanced or metastatic pancreatic cancer treated with gemcitabine with or without erlotinib.
  • Compare the progression-free survival rate in patients treated with these regimens.
  • Compare the quality of life of patients treated with these regimens.
  • Compare the response rate and response duration in patients treated with these regimens.
  • Compare the nature, severity, and frequency of toxic effects of these regimens in these patients.
  • Correlate the expression of tissue epidermal growth factor receptor levels at diagnosis with outcome and response in patients treated with these regimens.
  • Determine the pharmacokinetics of erlotinib in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center, extent of disease (locally advanced vs metastatic), and ECOG performance status (0-1 vs 2). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43 of course 1 only, which lasts 8 weeks, and on days 1, 8, and 15 of all subsequent courses, which last 4 weeks each. Patients also receive 1 of 2 doses of oral erlotinib once daily.
  • Arm II: Patients receive gemcitabine as in arm I and 1 of 2 doses of oral placebo once daily.

Treatment continues in both arms in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, on day 29 of course 1, on day 1 of all subsequent courses, at 4 weeks after study, and then every 12 weeks until disease progression.

Patients are followed at 4 weeks and then every 12 weeks thereafter.

PROJECTED ACCRUAL: A total of 800 patients (400 per treatment arm) will be accrued for this study within 11 months.

Being tested
erlotinib hydrochloride, gemcitabine hydrochloride
Keywords
stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • erlotinib hydrochlorideDrug

    150 mg po daily

  • gemcitabine hydrochlorideDrug

    1000 mg/m2 IV weekly (Cycle 1 -Day 1, 8, 15, 22, 29, 36, 43 of an 8 week cycle, Cycle 2 and subsequent cycles -Day 1,8 and 15 of a 4 week cycle)

Study groups in NCT00026338
Study groupRoleWhat they receive
OSI-774 plus GemcitabineActive comparatorNot described
Receives: Drug: erlotinib hydrochloride; Drug: gemcitabine hydrochloride
Placebo plus gemcitabineActive comparatorNot described
Receives: Drug: gemcitabine hydrochloride

What is being measured

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

  1. Overall survival

    Measured: 3 years

Secondary outcomes (6)

  1. Progression free survival

    Measured: 3 years

  2. Quality of Life

    Canada, US and selected countries only

    Measured: 3 years

  3. Response rates

    Complete and partial response only.

    Measured: 3 years

  4. Toxicity

    Measured: 3 years

  5. EGFR levels

    Correlate the expression oftissue EGFR levels (at diagnosis) with outcomes and response to treatment

    Measured: 3 years

  6. Pharmacokinetics

    To measure trough levels of081-774 (Tarceva™) to determine population pharmacokinetics

    Measured: 3 years

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study start29 Oct 2001
  3. Primary completion17 Sep 2004
  4. Study completion10 Feb 2009

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
569 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00026338
Sponsor's protocol ID
PA3
Other IDs
CAN-NCIC-PA3, OSI-CAN-NCIC-PA3, CDR0000069020
Status last verified
Mar 2020
First submitted
9 Nov 2001
Last updated
2 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dhani NC, Tu D, Parulekar W, et al.: A retrospective analysis of tumor size (TS) as a continuous rather than discrete variable in advanced pancreatic cancer. [Abstract] J Clin Oncol 27 (Suppl 15): A-e15565, 2009.

  • Moore MJ, da Cunha Santos G, Kamel-Reid S, et al.: The relationship of K-ras mutations and EGFR gene copy number to outcome in patients treated with Erlotinib on National Cancer Institute of Canada Clinical Trials Group trial study PA.3. [Abstract] J Clin Oncol 25 (Suppl 18): A-4521, 2007.

  • 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

  • Moore MJ, Goldstein D, Hamm J, et al.: Erlotinib improves survival when added to gemcitabine in patients with advanced pancreatic cancer. A phase III trial of the National Cancer Institute of Canada Clinical Trials Group [NCIC-CTG]. [Abstract] American Society of Clinical Oncology 2005 Gastrointestinal Cancers Symposium, 27-29 January 2005, Miami, Florida. A-77, 2005.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing erlotinib hydrochloride and gemcitabine hydrochloride in people with Pancreatic Cancer, run by NCIC Clinical Trials Group at 173 sites in 19 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 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 173 sites in United States, Canada, United Kingdom, Australia, Germany and 14 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?

Overall survival (time frame: 3 years). 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 NCT00026338, which also lists 4 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 2 Apr 2020.

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