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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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Scientific title
A Randomized Placebo Controlled Study Of OSI-774 (TARCEVA) Plus Gemcitabine In Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer
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Secondary ID [1]
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CAN-NCIC-PA3
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Secondary ID [2]
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0
PA3
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer
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Condition category
Condition code
Cancer
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0
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Pancreatic
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Intervention/exposure
Study type
Interventional
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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)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall survival
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Assessment method [1]
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Timepoint [1]
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3 years
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Secondary outcome [1]
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Progression free survival
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Assessment method [1]
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Timepoint [1]
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3 years
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Secondary outcome [2]
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Quality of Life
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Assessment method [2]
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Canada, US and selected countries only
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Timepoint [2]
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3 years
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Secondary outcome [3]
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Response rates
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Assessment method [3]
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Complete and partial response only.
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Timepoint [3]
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3 years
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Secondary outcome [4]
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Toxicity
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Assessment method [4]
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0
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Timepoint [4]
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3 years
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Secondary outcome [5]
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EGFR levels
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Assessment method [5]
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Correlate the expression oftissue EGFR levels (at diagnosis) with outcomes and response to treatment
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Timepoint [5]
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3 years
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Secondary outcome [6]
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Pharmacokinetics
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Assessment method [6]
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To measure trough levels of081-774 (Tarcevaâ„¢) to determine population pharmacokinetics
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Timepoint [6]
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3 years
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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
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Minimum age
18
Years
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Maximum age
120
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/10/2001
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
10/02/2009
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Sample size
Target
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Accrual to date
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Final
569
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Liverpool Hospital - Liverpool
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Newcastle Mater Misericordiae Hospital - Newcastle
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Institute of Oncology - Randwick
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Royal Adelaide Hospital - Adelaide
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Ashford Cancer Centre - Ashford
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Queen Elizabeth Hospital - Woodville
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Frankston Hospital - Frankston
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Austin and Repatriation Medical Centre - Heidelberg
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Royal Perth Hospital - Perth
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Peter MacCallum Cancer Institute - Melbourne
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2139 - Concord
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2170 - Liverpool
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NSW 2310 - Newcastle
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2031 - Randwick
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5000 - Adelaide
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5035 - Ashford
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5011 - Woodville
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3199 - Frankston
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3084 - Heidelberg
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6000 - Perth
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8006 - Melbourne
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Oxford
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Funding & Sponsors
Primary sponsor type
Other
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Name
NCIC Clinical Trials Group
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Address
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00026338
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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.
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Public notes
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Contacts
Principal investigator
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Malcolm J. Moore, MD
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Address
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Princess Margaret Hospital, Canada
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00026338
Download to PDF