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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/NCT00040183




Registration number
NCT00040183
Ethics application status
Date submitted
21/06/2002
Date registered
25/06/2002
Date last updated
10/01/2018

Titles & IDs
Public title
OSI-774 (Tarceva) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer.
Scientific title
A Randomized Placebo Controlled Study of OSI-774 (Tarceva (TM)) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
Secondary ID [1] 0 0
PA.3
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 - Tarceva (erlotinib HCl, OSI-774)

Treatment: Drugs: Tarceva (erlotinib HCl, OSI-774)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
Histologically or cytologically confirmed diagnosis of adenocarcinoma of the
pancreas;cancer which is unresectable, locally advanced or metastatic.

Must have evidence of disease (clinical or radiological). Male or female, 18 years or
older. Patients may have received prior radiation treatment for management of local disease
providing that disease progression has been documented.

All toxicities have resolved, and the last fraction of radiation treatment was completed at
least 4 weeks prior to randomization.

Patients may not have received prior chemotherapy, other then 5FU (+/- folic acid) or
gemcitabine given concurrently with radiation treatment as a 'radiosensitiser.'
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?



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
29/11/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/01/2004
Sample size
Target
Accrual to date
Final
569
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Concord Hospital - Concord
Recruitment hospital [2] 0 0
Newcastle Mater Hospital - HRMC Waratah
Recruitment hospital [3] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
Ashford Cancer Centre - Ashford
Recruitment hospital [6] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [7] 0 0
Frankston Hospital - Frankston
Recruitment hospital [8] 0 0
Austin & Repatriation Medical Centre - Heidelberg
Recruitment postcode(s) [1] 0 0
2139 - Concord
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2310 - HRMC Waratah
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2031 - Randwick
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5000 - Adelaide
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5035 - Ashford
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5011 - Woodville South
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3199 - Frankston
Recruitment postcode(s) [8] 0 0
3084 - Heidelberg
Recruitment outside Australia
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Germany
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Homburg
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Germany
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Wurzburg
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Greece
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Israel
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Haifa
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Israel
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Petach Tiqva
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Rehovot
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Israel
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Manchester
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Newcastle-Upon-Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
OSI Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Canadian Cancer Trials Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine if OSI-774 will improve overall survival when
combined with a standard dose of the chemotherapy drug gemcitabine, to individuals with
pancreatic cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00040183
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
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Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00040183