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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00026338




Registration number
NCT00026338
Ethics application status
Date submitted
9/11/2001
Date registered
27/01/2003
Date last updated
30/09/2011

Titles & IDs
Public title
Gemcitabine With or Without Erlotinib in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
Scientific title
A Randomized Placebo Controlled Study Of OSI-774 (TARCEVA) Plus Gemcitabine In Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer
Secondary ID [1] 0 0
CAN-NCIC-PA3
Secondary ID [2] 0 0
PA3
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - erlotinib hydrochloride
Treatment: Drugs - gemcitabine hydrochloride

Active Comparator: OSI-774 plus Gemcitabine -

Active Comparator: Placebo plus gemcitabine -


Treatment: Drugs: erlotinib hydrochloride
150 mg po daily

Treatment: Drugs: 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)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
Progression free survival
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
Quality of Life - Canada, US and selected countries only
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
Response rates - Complete and partial response only.
Timepoint [3] 0 0
3 years
Secondary outcome [4] 0 0
Toxicity
Timepoint [4] 0 0
3 years
Secondary outcome [5] 0 0
EGFR levels - Correlate the expression oftissue EGFR levels (at diagnosis) with outcomes and response to treatment
Timepoint [5] 0 0
3 years
Secondary outcome [6] 0 0
Pharmacokinetics - To measure trough levels of081-774 (Tarceva™) to determine population pharmacokinetics
Timepoint [6] 0 0
3 years

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Newcastle Mater Misericordiae Hospital - Newcastle
Recruitment hospital [4] 0 0
Institute of Oncology - Randwick
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Ashford Cancer Centre - Ashford
Recruitment hospital [7] 0 0
Queen Elizabeth Hospital - Woodville
Recruitment hospital [8] 0 0
Frankston Hospital - Frankston
Recruitment hospital [9] 0 0
Austin and Repatriation Medical Centre - Heidelberg
Recruitment hospital [10] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [11] 0 0
Peter MacCallum Cancer Institute - Melbourne
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
NSW 2310 - Newcastle
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
5035 - Ashford
Recruitment postcode(s) [7] 0 0
5011 - Woodville
Recruitment postcode(s) [8] 0 0
3199 - Frankston
Recruitment postcode(s) [9] 0 0
3084 - Heidelberg
Recruitment postcode(s) [10] 0 0
6000 - Perth
Recruitment postcode(s) [11] 0 0
8006 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
New Hampshire
Country [19] 0 0
United States of America
State/province [19] 0 0
New Jersey
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
State/province [21] 0 0
North Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
North Dakota
Country [23] 0 0
United States of America
State/province [23] 0 0
Ohio
Country [24] 0 0
United States of America
State/province [24] 0 0
Oregon
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Pennsylvania
Country [26] 0 0
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South Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Vermont
Country [30] 0 0
United States of America
State/province [30] 0 0
Virginia
Country [31] 0 0
United States of America
State/province [31] 0 0
Washington
Country [32] 0 0
United States of America
State/province [32] 0 0
Wisconsin
Country [33] 0 0
Argentina
State/province [33] 0 0
Buenos Aires
Country [34] 0 0
Argentina
State/province [34] 0 0
Lanus
Country [35] 0 0
Argentina
State/province [35] 0 0
San Isidro
Country [36] 0 0
Belgium
State/province [36] 0 0
Brussels
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Brazil
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Bahia
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Brazil
State/province [38] 0 0
Porto Alegre
Country [39] 0 0
Brazil
State/province [39] 0 0
Sao Paulo
Country [40] 0 0
Canada
State/province [40] 0 0
Alberta
Country [41] 0 0
Canada
State/province [41] 0 0
British Columbia
Country [42] 0 0
Canada
State/province [42] 0 0
Manitoba
Country [43] 0 0
Canada
State/province [43] 0 0
New Brunswick
Country [44] 0 0
Canada
State/province [44] 0 0
Newfoundland and Labrador
Country [45] 0 0
Canada
State/province [45] 0 0
Nova Scotia
Country [46] 0 0
Canada
State/province [46] 0 0
Ontario
Country [47] 0 0
Canada
State/province [47] 0 0
Quebec
Country [48] 0 0
Canada
State/province [48] 0 0
Saskatchewan
Country [49] 0 0
Chile
State/province [49] 0 0
Santiago
Country [50] 0 0
China
State/province [50] 0 0
Hong Kong
Country [51] 0 0
Germany
State/province [51] 0 0
Berlin
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Germany
State/province [52] 0 0
Essen
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Germany
State/province [53] 0 0
Frankfurt
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Germany
State/province [54] 0 0
Freiburg
Country [55] 0 0
Germany
State/province [55] 0 0
Halle
Country [56] 0 0
Germany
State/province [56] 0 0
Heidelberg
Country [57] 0 0
Germany
State/province [57] 0 0
Homburg/Saar
Country [58] 0 0
Germany
State/province [58] 0 0
Wurzburg
Country [59] 0 0
Greece
State/province [59] 0 0
Crete
Country [60] 0 0
Greece
State/province [60] 0 0
Thessaloniki
Country [61] 0 0
Hong Kong
State/province [61] 0 0
Shatin, New Territories
Country [62] 0 0
Israel
State/province [62] 0 0
Afula
Country [63] 0 0
Israel
State/province [63] 0 0
Haifa
Country [64] 0 0
Israel
State/province [64] 0 0
Petah-Tikva
Country [65] 0 0
Israel
State/province [65] 0 0
Rehovot
Country [66] 0 0
Israel
State/province [66] 0 0
Tel Hashomer
Country [67] 0 0
Israel
State/province [67] 0 0
Tel-Aviv
Country [68] 0 0
Italy
State/province [68] 0 0
Palermo
Country [69] 0 0
Mexico
State/province [69] 0 0
Distrito Federal
Country [70] 0 0
Mexico
State/province [70] 0 0
Dviango
Country [71] 0 0
New Zealand
State/province [71] 0 0
Auckland
Country [72] 0 0
New Zealand
State/province [72] 0 0
Christchurch
Country [73] 0 0
Poland
State/province [73] 0 0
Poznan
Country [74] 0 0
Poland
State/province [74] 0 0
Wroclaw
Country [75] 0 0
Romania
State/province [75] 0 0
Bucarest
Country [76] 0 0
Romania
State/province [76] 0 0
Cluj-Napoca
Country [77] 0 0
Romania
State/province [77] 0 0
Lasi
Country [78] 0 0
Romania
State/province [78] 0 0
Sibiu
Country [79] 0 0
Singapore
State/province [79] 0 0
Singapore
Country [80] 0 0
United Kingdom
State/province [80] 0 0
England
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Northern Ireland
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Wales
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Other
Name
NCIC Clinical Trials Group
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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. 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.
Trial website
https://clinicaltrials.gov/show/NCT00026338
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Malcolm J. Moore, MD
Address 0 0
Princess Margaret Hospital, Canada
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications