Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00652366
Registration number
NCT00652366
Ethics application status
Date submitted
1/04/2008
Date registered
3/04/2008
Date last updated
11/02/2015
Titles & IDs
Public title
A Dose-Escalation to Rash Study of Tarceva (Erlotinib) Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
Query!
Scientific title
A Randomized, Open-label, Dose-escalation to Rash Study to Assess the Effect of Tarceva in Combination With Gemcitabine on Overall Survival in Patients With Metastatic Pancreatic Cancer.
Query!
Secondary ID [1]
0
0
2007-003751-37
Query!
Secondary ID [2]
0
0
BO21128
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Pancreatic
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Erlotinib, escalating dose
Treatment: Drugs - Erlotinib, standard dose
Treatment: Drugs - Gemcitabine
Active Comparator: Gemcitabine, Erlotinib Standard Dose - Participants received erlotinib, 100 milligrams (mg), orally (PO), once daily until disease progression or unacceptable toxicity. Participants also received gemcitabine, 1000 mg per (/) square meter (m^2), intravenously (IV), on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression or unacceptable toxicity.
Experimental: Gemcitabine, Erlotinib Escalating Dose - Participants received erlotinib, beginning at 150 mg/day, PO, once daily, and increasing in increments of 50 mg every 2 weeks up to a maximum of 250 mg/day, until development of a grade 2 rash, or occurrence of other, non-rash, dose-limiting toxicity; treatment was continued until disease progression, unacceptable toxicity, death or withdrawal. Participants also received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of consecutive 4 week cycles until disease progression or unacceptable toxicity.
Treatment: Drugs: Erlotinib, escalating dose
100mg, PO, once daily, escalating to a maximum of 250mg, PO, once daily
Treatment: Drugs: Erlotinib, standard dose
100mg, PO, once daily
Treatment: Drugs: Gemcitabine
1000 mg/m2, IV, on days 1,8 and 15 of each 4 week cycle
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants Who Died Assessed From Point of Randomization
Query!
Assessment method [1]
0
0
Overall survival (OS) assessed from the point of randomization was defined as the time from randomization to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive.
Query!
Timepoint [1]
0
0
Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.
Query!
Primary outcome [2]
0
0
OS Assessed From Point of Randomization
Query!
Assessment method [2]
0
0
OS assessed from the point of randomization was defined as the median time, in months, from randomization to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. The 95 percent (%) confidence interval (CI) was determined using Kaplan-Meier methodology.
Query!
Timepoint [2]
0
0
Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.
Query!
Secondary outcome [1]
0
0
Percentage of Participants With Disease Progression or Death as Assessed From Point of Randomization
Query!
Assessment method [1]
0
0
Progression-free survival (PFS) as assessed from the point of randomization was defined as the time from randomization to the first occurrence of progressive disease (PD) according to the Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause. For target lesions (TLs), PD was defined as at least a 20% increase in the sum of longest diameter (SLD) of TLs, taking as reference the smallest SLD recorded since the treatment started. For non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment.
Query!
Timepoint [1]
0
0
Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.
Query!
Secondary outcome [2]
0
0
PFS Assessed From Point of Randomization
Query!
Assessment method [2]
0
0
PFS assessed from the point of randomization was defined as the median time, in weeks, from randomization to disease progression or death due to any cause. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment. The 95% CI was determined using Kaplan-Meier methodology.
Query!
Timepoint [2]
0
0
Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.
Query!
Secondary outcome [3]
0
0
Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST
Query!
Assessment method [3]
0
0
BOR was defined as a confirmed CR or PR for at least 4 weeks. CR was defined as the disappearance of all TLs. PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. The 95% CI for one sample binomial was determined using Pearson-Clopper method.
Query!
Timepoint [3]
0
0
BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.
Query!
Secondary outcome [4]
0
0
Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST
Query!
Assessment method [4]
0
0
CR was defined as the disappearance of all TLs. PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.
Query!
Timepoint [4]
0
0
BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.
Query!
Secondary outcome [5]
0
0
Percentage of Participants With SD (Maintained for at Least 8 Weeks) or CR or PR (Maintained for at Least 4 Weeks) According to RECIST
Query!
Assessment method [5]
0
0
Disease control was defined as a participant with a response of CR or PR for at least 4 weeks at any time during treatment, or SD that was maintained for at least 8 weeks after the start of treatment. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.
Query!
Timepoint [5]
0
0
BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.
Query!
Secondary outcome [6]
0
0
Percentage of Participants Who Died as Assessed From Start of 4-Week Run-In
Query!
Assessment method [6]
0
0
OS assessed from the start of the 4-week run in period was defined as the time from BL to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive.
Query!
Timepoint [6]
0
0
BL and weekly thereafter for up to 46 months.
Query!
Secondary outcome [7]
0
0
OS Assessed From Start of 4-Week Run-In
Query!
Assessment method [7]
0
0
OS assessed from the start of the 4-week run in period was defined as the median time, in months, from BL to the date of death, due to any cause. Participants who were still alive at the time of analysis were censored at the date they were last known to be alive. The 95% CI was determined using Kaplan-Meier methodology.
Query!
Timepoint [7]
0
0
BL and weekly thereafter for up to 46 months.
Query!
Secondary outcome [8]
0
0
Percentage of Participants With Disease Progression or Death as Assessed From the Start of 4-Week Run-In
Query!
Assessment method [8]
0
0
PFS as assessed from the start of 4-week run-in was defined as the time from BL to the first occurrence of PD according to RECIST or death due to any cause. For TLs, PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, PD was defined as unequivocal progression of existing NTLs. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment.
Query!
Timepoint [8]
0
0
BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression or death for up to 46 months.
Query!
Secondary outcome [9]
0
0
PFS Assessed From the Start of 4-Week Run-In
Query!
Assessment method [9]
0
0
PFS assessed from the start of 4-week run-in was defined as the median time, in weeks, from BL to disease progression or death due to any cause. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment. The 95% CI was determined using Kaplan-Meier methodology.
Query!
Timepoint [9]
0
0
BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression or death for up to 46 months.
Query!
Eligibility
Key inclusion criteria
- adult patients, >=18 years of age;
- histologically or cytologically confirmed pancreatic cancer with measurable or
non-measurable metastatic disease;
- ECOG performance status of 0-1.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- local, or locally advanced, pancreatic cancer;
- prior systemic treatment for metastatic pancreatic cancer;
- <=6 months since last adjuvant chemotherapy;
- other malignancies within last 5 years, except for adequately treated cancer in situ
of the cervix, or basal or squamous cell skin cancer.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/05/2008
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/02/2012
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
467
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
- Canberra
Query!
Recruitment hospital [2]
0
0
- Liverpool
Query!
Recruitment hospital [3]
0
0
- St. Leonards
Query!
Recruitment hospital [4]
0
0
- Sydney
Query!
Recruitment hospital [5]
0
0
- Brisbane
Query!
Recruitment hospital [6]
0
0
- Adelaide
Query!
Recruitment hospital [7]
0
0
- Ballarat
Query!
Recruitment hospital [8]
0
0
- Frankston
Query!
Recruitment postcode(s) [1]
0
0
2606 - Canberra
Query!
Recruitment postcode(s) [2]
0
0
2170 - Liverpool
Query!
Recruitment postcode(s) [3]
0
0
2065 - St. Leonards
Query!
Recruitment postcode(s) [4]
0
0
2076 - Sydney
Query!
Recruitment postcode(s) [5]
0
0
4101 - Brisbane
Query!
Recruitment postcode(s) [6]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [7]
0
0
03350 - Ballarat
Query!
Recruitment postcode(s) [8]
0
0
3199 - Frankston
Query!
Recruitment outside Australia
Country [1]
0
0
Argentina
Query!
State/province [1]
0
0
Buenos Aires
Query!
Country [2]
0
0
Argentina
Query!
State/province [2]
0
0
Florencio Varela
Query!
Country [3]
0
0
Argentina
Query!
State/province [3]
0
0
Rosario
Query!
Country [4]
0
0
Argentina
Query!
State/province [4]
0
0
Santa Fe
Query!
Country [5]
0
0
Austria
Query!
State/province [5]
0
0
Salzburg
Query!
Country [6]
0
0
Austria
Query!
State/province [6]
0
0
Wien
Query!
Country [7]
0
0
Belgium
Query!
State/province [7]
0
0
Antwerpen
Query!
Country [8]
0
0
Belgium
Query!
State/province [8]
0
0
Bruxelles
Query!
Country [9]
0
0
Belgium
Query!
State/province [9]
0
0
Gent
Query!
Country [10]
0
0
Belgium
Query!
State/province [10]
0
0
Leuven
Query!
Country [11]
0
0
Belgium
Query!
State/province [11]
0
0
Liege
Query!
Country [12]
0
0
Brazil
Query!
State/province [12]
0
0
BA
Query!
Country [13]
0
0
Brazil
Query!
State/province [13]
0
0
MG
Query!
Country [14]
0
0
Brazil
Query!
State/province [14]
0
0
RS
Query!
Country [15]
0
0
Brazil
Query!
State/province [15]
0
0
SP
Query!
Country [16]
0
0
Canada
Query!
State/province [16]
0
0
Ontario
Query!
Country [17]
0
0
Croatia
Query!
State/province [17]
0
0
Zagreb
Query!
Country [18]
0
0
Denmark
Query!
State/province [18]
0
0
Herlev
Query!
Country [19]
0
0
Denmark
Query!
State/province [19]
0
0
Hillerod
Query!
Country [20]
0
0
Denmark
Query!
State/province [20]
0
0
København
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Angers
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Besancon
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Brest
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Paris
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
St-Priest-En-Jarez
Query!
Country [26]
0
0
Germany
Query!
State/province [26]
0
0
Berlin
Query!
Country [27]
0
0
Germany
Query!
State/province [27]
0
0
Bochum
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Bonn
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Esslingen
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Halle
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Hamburg
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Hamm
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Kaiserslautern
Query!
Country [34]
0
0
Germany
Query!
State/province [34]
0
0
Leipzig
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Marburg
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Muenchen
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Mönchengladbach
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
Saarbruecken
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Trier
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Ulm
Query!
Country [41]
0
0
Greece
Query!
State/province [41]
0
0
Heraklion
Query!
Country [42]
0
0
Greece
Query!
State/province [42]
0
0
Thessaloniki
Query!
Country [43]
0
0
Hong Kong
Query!
State/province [43]
0
0
Hong Kong
Query!
Country [44]
0
0
Israel
Query!
State/province [44]
0
0
Haifa
Query!
Country [45]
0
0
Israel
Query!
State/province [45]
0
0
Jerusalem
Query!
Country [46]
0
0
Israel
Query!
State/province [46]
0
0
Petach Tikva
Query!
Country [47]
0
0
Israel
Query!
State/province [47]
0
0
Tel Aviv
Query!
Country [48]
0
0
Israel
Query!
State/province [48]
0
0
Zerifin
Query!
Country [49]
0
0
Italy
Query!
State/province [49]
0
0
Abruzzo
Query!
Country [50]
0
0
Italy
Query!
State/province [50]
0
0
Campania
Query!
Country [51]
0
0
Italy
Query!
State/province [51]
0
0
Friuli-Venezia Giulia
Query!
Country [52]
0
0
Italy
Query!
State/province [52]
0
0
Piemonte
Query!
Country [53]
0
0
Italy
Query!
State/province [53]
0
0
Puglia
Query!
Country [54]
0
0
Italy
Query!
State/province [54]
0
0
Toscana
Query!
Country [55]
0
0
Lithuania
Query!
State/province [55]
0
0
Vilnius
Query!
Country [56]
0
0
Mexico
Query!
State/province [56]
0
0
Distrito Federal
Query!
Country [57]
0
0
Poland
Query!
State/province [57]
0
0
Gliwice
Query!
Country [58]
0
0
Poland
Query!
State/province [58]
0
0
Lublin
Query!
Country [59]
0
0
Poland
Query!
State/province [59]
0
0
Poznan
Query!
Country [60]
0
0
Poland
Query!
State/province [60]
0
0
Warszawa
Query!
Country [61]
0
0
Romania
Query!
State/province [61]
0
0
Brasov
Query!
Country [62]
0
0
Romania
Query!
State/province [62]
0
0
Bucuresti
Query!
Country [63]
0
0
Romania
Query!
State/province [63]
0
0
Cluj Napoca
Query!
Country [64]
0
0
Romania
Query!
State/province [64]
0
0
Sibiu
Query!
Country [65]
0
0
Serbia
Query!
State/province [65]
0
0
Belgrade
Query!
Country [66]
0
0
Serbia
Query!
State/province [66]
0
0
Sremska Kamenica
Query!
Country [67]
0
0
Singapore
Query!
State/province [67]
0
0
Singapore
Query!
Country [68]
0
0
Spain
Query!
State/province [68]
0
0
Madrid
Query!
Country [69]
0
0
Taiwan
Query!
State/province [69]
0
0
Taipei
Query!
Country [70]
0
0
United Kingdom
Query!
State/province [70]
0
0
London
Query!
Country [71]
0
0
United Kingdom
Query!
State/province [71]
0
0
Salisbury
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Hoffmann-La Roche
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study will compare the efficacy and safety of escalating versus standard doses to rash
of Tarceva, in combination with gemcitabine, in patients with metastatic pancreatic cancer.
During a 4 week run-in period, all patients will receive Tarceva 100mg/day po plus
gemcitabine 1000mg/m2 iv on days 1, 8,15 and 22. After 4 weeks, patients who have not
developed rash, or only develop grade 1 rash, will be randomized to one of 2 groups. Group 1
will receive a starting dose of Tarceva 150mg po daily, increased in steps of 50mg every 2
weeks up to a maximum of 250mg/day po, until development of grade 2 rash or other
dose-limiting toxicity. Group 2 will continue to receive Tarceva 100mg/day po. All patients
will continue to receive gemcitabine 1000mg/m2 iv on days 1, 8 and 15 of each 4 week cycle.
The anticipated time on study treatment is until disease progression, and the target sample
size is 100-500 individuals.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00652366
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Trials
Query!
Address
0
0
Hoffmann-La Roche
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00652366
Download to PDF