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

March 31, 2020 updated by: NCIC Clinical Trials Group

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

569

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1280
        • Hospital Británico
      • Buenos Aires, Argentina, 1426
        • Instituto Alexander Fleming
      • Buenos Aires, Argentina, 1417
        • Instituto de Oncología Angel H. Roffo
      • Buenos Aires, Argentina, 1437
        • Hospital Churruca
      • Buenos Aires, Argentina, CP1181ACH
        • Hospital Italiano
      • Lanus, Argentina, 1824
        • Hospital Interzonal De Augudos Euita
      • San Isidro, Argentina, 1642
        • Confidence Medical Center
  • Australia
      • Melbourne, Australia, 8006
        • Peter MacCallum Cancer Institute
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital
      • Newcastle, New South Wales, Australia, NSW 2310
        • Newcastle Mater Misericordiae Hospital
      • Randwick, New South Wales, Australia, 2031
        • Institute of Oncology
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
      • Ashford, South Australia, Australia, 5035
        • Ashford Cancer Centre
      • Woodville, South Australia, Australia, 5011
        • Queen Elizabeth Hospital
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Frankston Hospital
      • Heidelberg, Victoria, Australia, 3084
        • Austin and Repatriation Medical Centre
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • Belgium
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
  • Brazil
      • Bahia, Brazil, 40170-070
        • Nucleo de Oncologia da Bahia
      • Porto Alegre, Brazil, 91330-490
        • Hospital Santa Rita Irtmandade Santa Casa De Porto Alegre
      • Sao Paulo, Brazil, 05651-901
        • Hospital Israelita Albert Einstein
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • British Columbia Cancer Agency - Centre for the Southern Interior
      • Penticton, British Columbia, Canada, V2A 3G6
        • Penticton Regional Hospital
      • Surrey, British Columbia, Canada, V3V 1Z2
        • British Columbia Cancer Agency - Fraser Valley Cancer Centre
      • Victoria, British Columbia, Canada, V8R 6V5
        • British Columbia Cancer Agency
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Saint John Regional Hospital
    • Newfoundland and Labrador
      • St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
        • Newfoundland Cancer Treatment and Research Foundation
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Queen Elizabeth II Health Science Centre
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Royal Victoria Hospital, Barrie
      • Hamilton, Ontario, Canada, L8V 5C2
        • Cancer Care Ontario-Hamilton Regional Cancer Centre
      • Kingston, Ontario, Canada, K7L 5P9
        • Kingston Regional Cancer Centre
      • London, Ontario, Canada, N6A 4L6
        • Cancer Care Ontario-London Regional Cancer Centre
      • Mississauga, Ontario, Canada, L5M 2N1
        • Credit Valley Hospital
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Southlake Regional Health Centre
      • Ottawa, Ontario, Canada, K1H 1C4
        • Ottawa Regional Cancer Centre
      • Peterborough, Ontario, Canada, K9H 7B6
        • Peterborough Oncology Clinic
      • Sault Sainte Marie, Ontario, Canada, P6B 1Y5
        • Algoma District Medical Group
      • St. Catharines, Ontario, Canada, L2R 5K3
        • Hotel Dieu Health Sciences Hospital - Niagara
      • Toronto, Ontario, Canada, M4C 3E7
        • Toronto East General Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Toronto Sunnybrook Regional Cancer Centre
      • Toronto, Ontario, Canada, M6R 1B5
        • Saint Joseph's Health Centre - Toronto
      • Toronto, Ontario, Canada, M4X 1K9
        • Ontario Cancer Institute
      • Toronto, Ontario, Canada, M4X 1K9
        • Toronto General Hospital
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Maisonneuve-Rosemont Hospital
      • Montreal, Quebec, Canada, H4J 1C5
        • Hôpital du Sacré-Coeur de Montréal
      • Ste-Foy, Quebec, Canada, G1V 4G5
        • L'Hopital Laval
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
  • Chile
      • Santiago, Chile
        • Clinica Las Condes
  • China
      • Hong Kong, China
        • Queen Mary Hospital
      • Hong Kong, China
        • Pamela Youde Nethersole Eastern Hospital
  • Germany
      • Berlin, Germany, D-13353
        • Virchow Klinikum Humboldt Universitaet Berlin
      • Essen, Germany, D-45122
        • Universitaetsklinik und Strahlenklinik - Essen
      • Frankfurt, Germany, DOH-65929
        • Stadtische Kliniken Frankfurt-Hochst
      • Freiburg, Germany, D-79106
        • Tumor Biology Center at the Albert - Ludwigs University
      • Halle, Germany, DOH-06112
        • Martin Luther Universitaet
      • Heidelberg, Germany, D-69115
        • Medizinische Universitaetsklinik und Poliklinik
      • Homburg/Saar, Germany, D-66421
        • Universitatsklinik, Saarland
      • Wurzburg, Germany, D-97070
        • University Würzburg
  • Greece
      • Thessaloniki, Greece, 54642
        • Hippokration Hospital
      • Thessaloniki, Greece, 540 07
        • Theagenio Medical Institute
    • Crete
      • Iraklion (Heraklion), Crete, Greece, 71110
        • University Hospital of Heraklion
  • Hong Kong
      • Shatin, New Territories, Hong Kong, NT
        • Prince of Wales Hospital
  • Israel
      • Afula, Israel, 18101
        • Haemek Medical Center
      • Haifa, Israel, 31096
        • Rambam Medical Center
      • Petah-Tikva, Israel, 49100
        • Rabin Medical Center - Beilinson Campus
      • Petah-Tikva, Israel, 49372
        • Rabin Medical Center - Golda-Hasharon Campus
      • Rehovot, Israel, 76100
        • Kaplan Hospital
      • Tel Hashomer, Israel, 52621
        • Sheba Medical Center
      • Tel-Aviv, Israel, 64239
        • Tel-Aviv Sourasky Medical Center
  • Italy
      • Palermo, Italy, 90100
        • Policlinico - Cattedra di Ematologia
  • Mexico
      • Dviango, Mexico, 34000
        • Centro Estatal de Cancerología
    • Distrito Federal
      • Tlalpan, Distrito Federal, Mexico, 22
        • Instituto Nac de Cancerologia
  • New Zealand
      • Auckland, New Zealand, 1
        • Auckland Hospital
      • Christchurch, New Zealand, 1
        • Christchurch Hospital
  • Poland
      • Poznan, Poland, 61 866
        • Great Poland Cancer Center
      • Wroclaw, Poland, 53-413
        • Dolnoslaskie Centrum Oncology
  • Romania
      • Bucarest, Romania, RO 72435
        • Institute of Oncology - Bucarest
      • Cluj-Napoca, Romania, 3400
        • Institutul Oncologic-Universitatea de Medicina
      • Lasi, Romania, 6600
        • St. Spiridon University Hospital
      • Sibiu, Romania, 2400
        • Clinical County Hospital of Sibiu
  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital
      • Singapore, Singapore, 169610
        • National Cancer Centre - Singapore
      • Singapore, Singapore, 168609
        • Singapore General Hospital
  • United Kingdom
      • Oxford, United Kingdom, OX3 7LJ
        • Churchill Hospital
    • England
      • Birmingham, England, United Kingdom, B18 7QH
        • Queen Elizabeth Hospital
      • Edmonton, London, England, United Kingdom, NI8 1QX
        • North Middlesex Hospital
      • Guildford, England, United Kingdom, GU2 5XX
        • St. Luke's Cancer Center
      • Hull, England, United Kingdom, HU8 9HE
        • Princess Royal Hospital
      • London, England, United Kingdom, EC1A 7BE
        • Saint Bartholomew's Hospital
      • London, England, United Kingdom, SE1 9RT
        • Guy's and St. Thomas' Hospitals NHS Trust
      • Manchester, England, United Kingdom, M20 4BX
        • Christie Hospital N.H.S. Trust
      • Newcastle upon Tyne, England, United Kingdom, NE4 6BE
        • Northern Centre for Cancer Treatment
      • Southampton, England, United Kingdom, SO14 0YG
        • Royal South Hants Hospital
      • Wolverhampton, England, United Kingdom, WV10 0QP
        • New Cross Hospital
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT9 7AB
        • Belfast City Hospital Trust
    • Wales
      • Cardiff, Wales, United Kingdom, CF4 7XL
        • Velindre Hospital
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Arizona Clinical Research Center
    • Arkansas
      • Springdale, Arkansas, United States, 72764
        • Highlands Oncology Group
    • California
      • Berkeley, California, United States, 94704
        • Alta Bates Comprehensive Cancer Center
      • Greenbrae, California, United States, 94904
        • Sutter Health West Cancer Research Group
      • Loma Linda, California, United States, 92354
        • Loma Linda University Cancer Institute
      • Los Angeles, California, United States, 90057
        • Kenmar Research Institute
      • Los Angeles, California, United States, 90033-0804
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Los Angeles, California, United States, 90067
        • Century City Hospital
      • Los Angeles, California, United States, 90095-7059
        • David Geffen School of Medicine
      • San Diego, California, United States, 92120
        • Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
    • Connecticut
      • Manchester, Connecticut, United States, 06040
        • Davis, Posteraro, & Wasser, MDs, LLP
      • New Britain, Connecticut, United States, 06050-2000
        • New Britain General Hospital
      • Norwich, Connecticut, United States, 06360
        • Eastern Connecticut Hematology and Oncology Associates
      • Stamford, Connecticut, United States, 06902
        • Hematology Oncology, P.C.
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists
      • Miami, Florida, United States, 33176
        • Oncology-Hematology Group of South Florida
      • Ocala, Florida, United States, 34471-5563
        • Ocala Oncology Center
      • Tamarac, Florida, United States, 33321
        • Oncology & Hematology Associates of West Broward
      • Tampa, Florida, United States, 33612-9497
        • Moffitt Clinic at Tampa General Hospital
    • Georgia
      • Macon, Georgia, United States, 31201
        • Central Georgia Hematology Oncology, P.C.
    • Idaho
      • Boise, Idaho, United States, 83712
        • Mountain States Tumor Institute
    • Illinois
      • Arlington Heights, Illinois, United States, 60004
        • Northwest Medical Specialists, P.C.
      • Hines, Illinois, United States, 60141
        • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
      • Peoria, Illinois, United States, 61602
        • Oncology/Hematology Associates of Central Illinois, P.C.
      • Skokie, Illinois, United States, 60076
        • Midwest Cancer Research Group, Inc.
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
    • Indiana
      • Muncie, Indiana, United States, 47304
        • Medical Consultants
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Kansas City, Kansas, United States, 66160-7353
        • University of Kansas Medical Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0093
        • Lucille Parker Markey Cancer Center, University of Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Healthcare Pavilion
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Mary Bird Perkins Cancer Center
      • Metairie, Louisiana, United States, 70006
      • New Orleans, Louisiana, United States, 70112-2699
        • Tulane Cancer Center
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Annapolis Medical Specialists
      • Baltimore, Maryland, United States, 21215
        • Sinai Hospital of Baltimore
      • Baltimore, Maryland, United States, 21231
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02135-2997
        • St. Elizabeth's Medical Center
      • Boston, Massachusetts, United States, 02111
        • Tuft-New England Medical Center
      • Pittsfield, Massachusetts, United States, 01201
        • Berkshire Physicians and Surgeons, P.C.
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Cancer Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Midwest Oncology Consortium
    • New Hampshire
      • Hooksett, New Hampshire, United States, 03106
        • New Hampshire Oncology-Hematology PA
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • St. Barnabas Medical Center
      • Mount Holly, New Jersey, United States, 08060
        • Hematology-Oncology Associates
      • Voorhees, New Jersey, United States, 08043
        • Cooper Cancer Institute
    • New York
      • Glens Falls, New York, United States, 12801
        • Cancer Center at Glens Falls Hospital
      • Great Neck, New York, United States, 11021
        • Arena Oncology Associates
      • New York, New York, United States, 10016
        • NYU School of Medicine's Kaplan Comprehensive Cancer Center
      • New York, New York, United States, 10019
        • Beth Israel Medical Center
      • Rochester, New York, United States, 14623
        • Interlakes Oncology/Hematology PC
      • Staten Island, New York, United States, 10305
        • Staten Island University Hospital
      • Stony Brook, New York, United States, 11794-8174
        • University Hospital - Stony Brook
    • North Carolina
      • Charlotte, North Carolina, United States, 28233-3549
        • Presbyterian Hospital
    • North Dakota
      • Bismarck, North Dakota, United States, 58502-5538
        • Mid Dakota Clinic, P.C.
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland
    • Oregon
      • Portland, Oregon, United States, 97213-2967
        • Earle A. Chiles Research Institute at Providence Portland Medical Center
    • Pennsylvania
      • Dunmore, Pennsylvania, United States, 18512
        • Hematology-Oncology Association of NE Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Cancer Center
      • Philadelphia, Pennsylvania, United States, 19106
        • Pennsylvania Oncology Hematology Associates
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Charleston Hematology-Oncology, P.A.
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon-Minnie Pearl Cancer Center
    • Texas
      • Arlington, Texas, United States, 76012
        • Arlington Cancer Center
      • Austin, Texas, United States, 78705
        • Southwest Regional Cancer Center
      • Fort Worth, Texas, United States, 76104
        • Texas Cancer Care
      • Houston, Texas, United States, 77030-4009
        • University of Texas - MD Anderson Cancer Center
      • Tyler, Texas, United States, 75701
        • Tyler Hematology Oncology, P.A.
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Green Mountain Oncology Group
    • Virginia
      • Mechanicsville, Virginia, United States, 23116
        • Hematology & Oncology Associates of Virginia
    • Washington
      • Olympia, Washington, United States, 98502
        • Western Washington Oncology
      • Vancouver, Washington, United States, 98664
        • Southwest Washington Medical Center
    • Wisconsin
      • Glendale, Wisconsin, United States, 53212
        • Oncology of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: OSI-774 plus Gemcitabine
Drug: erlotinib hydrochloride
150 mg po daily
Drug: gemcitabine hydrochloride
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)
ACTIVE_COMPARATOR: Placebo plus gemcitabine
Drug: gemcitabine hydrochloride
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: 3 years
3 years
Toxicity
Time Frame: 3 years
3 years
Quality of Life
Time Frame: 3 years
Canada, US and selected countries only
3 years
Response rates
Time Frame: 3 years
Complete and partial response only.
3 years
EGFR levels
Time Frame: 3 years
Correlate the expression oftissue EGFR levels (at diagnosis) with outcomes and response to treatment
3 years
Pharmacokinetics
Time Frame: 3 years
To measure trough levels of081-774 (Tarceva™) to determine population pharmacokinetics
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NCIC Clinical Trials Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 29, 2001

Primary Completion (ACTUAL)

September 17, 2004

Study Completion (ACTUAL)

February 10, 2009

Study Registration Dates

First Submitted

November 9, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (ESTIMATE)

January 27, 2003

Study Record Updates

Last Update Posted (ACTUAL)

April 2, 2020

Last Update Submitted That Met QC Criteria

March 31, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA3
  • CAN-NCIC-PA3 (OTHER: PDQ)
  • OSI-CAN-NCIC-PA3 (OTHER: OSI)
  • CDR0000069020 (OTHER: PDQ)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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