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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00026338
Ethics application status
Date submitted
9/11/2001
Date registered
27/01/2003
Date last updated
2/04/2020

Titles & IDs
Public title
Gemcitabine With/Out Erlotinib in Unresectable Locally Advanced/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
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
Response rates
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
Timepoint [5] 0 0
3 years
Secondary outcome [6] 0 0
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
120 Years
Sex
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
29/10/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/02/2009
Sample size
Target
Accrual to date
Final
569
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
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United States of America
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Arizona
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Arkansas
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Idaho
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Minnesota
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Missouri
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New Hampshire
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New Jersey
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New York
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North Carolina
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North Dakota
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Ohio
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Oregon
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South Carolina
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Tennessee
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Texas
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Vermont
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Virginia
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Washington
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Wisconsin
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Argentina
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Lanus
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British Columbia
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Manitoba
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New Brunswick
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Canada
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Newfoundland and Labrador
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Nova Scotia
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Ontario
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Quebec
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Chile
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Santiago
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China
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Hong Kong
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Germany
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Berlin
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Germany
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Essen
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Frankfurt
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Germany
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Freiburg
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Germany
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Halle
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Germany
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Heidelberg
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Germany
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Homburg/Saar
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Germany
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Wurzburg
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Greece
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Crete
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Greece
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Thessaloniki
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Hong Kong
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Shatin, New Territories
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Israel
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Afula
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Israel
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Haifa
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Israel
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Petah-Tikva
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Israel
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Rehovot
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Israel
State/province [66] 0 0
Tel Hashomer
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Israel
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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
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Dviango
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New Zealand
State/province [71] 0 0
Auckland
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New Zealand
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Christchurch
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Poland
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Poznan
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Poland
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Wroclaw
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Romania
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Bucarest
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Romania
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Cluj-Napoca
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Romania
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Lasi
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Romania
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Sibiu
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Singapore
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Singapore
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United Kingdom
State/province [80] 0 0
England
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United Kingdom
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Northern Ireland
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Wales
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United Kingdom
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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/study/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.
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.
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.
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. 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. 2023 Oct 20;41(30):4714-4720. doi: 10.1200/JCO.22.02770.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00026338