Pancreatic CancerPhase 2NCT00652366
A Dose-Escalation to Rash Study of Tarceva (Erlotinib) Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
A Phase 2 study testing Erlotinib, escalating dose, Erlotinib, standard dose and Gemcitabine in people with Pancreatic Cancer, run by Hoffmann-La Roche at 89 sites in 23 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Erlotinib, escalating dose, Erlotinib, standard dose and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 467 participants
- Where
- 89 sitesin 23 countries
- Study dates
- May 2008to Feb 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
89 sites in 23 countries.
89 sites in 23 countries
Germany15 sites
Study site
Berlin, 13353
Study site
Bochum, 44791
Study site
Bonn, 53127
Study site
Esslingen am Neckar, 73730
Study site
Halle, 06120
Study site
Hamburg, 22081
Study site
Hamm, 59071
Study site
Kaiserslautern, 67655
Study site
Leipzig, 04103
Study site
Marburg, 35043
Study site
Mönchengladbach, 41063
Study site
München, 81377
Study site
Saarbrücken, 66113
Study site
Trier, 54290
Study site
Ulm, 89081
Australia8 sites
Study site
Adelaide, South Australia, 5000
Study site
Ballarat, Victoria, 03350
Study site
Brisbane, Queensland, 4101
Study site
Canberra, Australian Capital Territory, 2606
Study site
Frankston, Victoria, 3199
Study site
Liverpool, New South Wales, 2170
Study site
St Leonards, New South Wales, 2065
Study site
Sydney, New South Wales, 2076
Italy7 sites
Study site
Chieti, Abruzzo, 66100
Study site
Florence, Tuscany, 50139
Study site
Naples, Campania, 80131
Study site
Orbassano, Piedmont, 10043
Study site
Pordenone, Friuli Venezia Giulia, 33170
Study site
San Giovanni Rotondo, Apulia, 71013
Study site
Udine, Friuli Venezia Giulia, 33100
Belgium5 sites
Study site
Antwerp, 2020
Study site
Brussels, 1070
Study site
Ghent, 9000
Study site
Leuven, 3000
Study site
Liège, 4000
Brazil5 sites
Study site
Belo Horizonte, Minas Gerais, 30110-0090
Study site
Ijuí, Rio Grande do Sul, 98700-000
Study site
Salvador, Estado de Bahia, 40170-110
Study site
Santo André, São Paulo, 09060-650
Study site
São Paulo, São Paulo, 01246-000
France5 sites
Study site
Angers, 49933
Study site
Besançon, 25030
Study site
Brest, 29609
Study site
Paris, 75679
Study site
Saint-Priest-en-Jarez, 42271
Israel5 sites
Study site
Haifa, 34354
Study site
Jerusalem, 91120-01
Study site
Petah Tikva, 49100
Study site
Tel Aviv, 64239-06
Study site
Tsrifin, 70300
Argentina4 sites
Study site
Buenos Aires, C1264AAA
Study site
Rosario, S2000PBJ
Study site
San Juan Bautista, B1878DVB
Study site
Santa Fe, 03000
Poland4 sites
Study site
Gliwice, 44-101
Study site
Lublin, 20-081
Study site
Poznan, 60-569
Study site
Warsaw, 02-781
Romania4 sites
Study site
Brasov, 2200
Study site
Bucharest, 022328
Study site
Cluj-Napoca, 400015
Study site
Sibiu, 550245
Spain4 sites
Study site
Madrid, Madrid, 28033
Study site
Madrid, Madrid, 28034
Study site
Madrid, Madrid, 28050
Study site
Madrid, Madrid, 28223
Denmark3 sites
Study site
Copenhagen, 2100
Study site
Herlev, 2730
Study site
Hillerød, 3400
Canada2 sites
Study site
Mississauga, Ontario, L5M 2N1
Study site
Toronto, Ontario, M5G 2M9
United Kingdom2 sites
Study site
London, SE1 9RT
Study site
Salisbury, SP2 8BJ
About this study
Official 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.
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.
- Conditions
- Pancreatic Cancer
- Being tested
- Erlotinib, escalating dose, Erlotinib, standard dose, Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erlotinib, escalating doseDrug
Also called Tarceva
100mg, PO, once daily, escalating to a maximum of 250mg, PO, once daily
Erlotinib, standard doseDrug
Also called Tarceva
100mg, PO, once daily
GemcitabineDrug
1000 mg/m2, IV, on days 1,8 and 15 of each 4 week cycle
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine, Erlotinib Standard Dose | Active comparator | 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. Receives: Drug: Erlotinib, standard dose; Drug: Gemcitabine |
| Gemcitabine, Erlotinib Escalating Dose | Experimental | 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. Receives: Drug: Erlotinib, escalating dose; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Died Assessed From Point of Randomization
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.
Measured: Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.
OS Assessed From Point of Randomization
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.
Measured: Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.
Secondary outcomes (9)
Percentage of Participants With Disease Progression or Death as Assessed From Point of Randomization
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.
Measured: Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.
PFS Assessed From Point of Randomization
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.
Measured: Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.
Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST
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.
Measured: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.
Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST
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.
Measured: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.
Percentage of Participants With SD (Maintained for at Least 8 Weeks) or CR or PR (Maintained for at Least 4 Weeks) According to RECIST
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.
Measured: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.
Percentage of Participants Who Died as Assessed From Start of 4-Week Run-In
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.
Measured: BL and weekly thereafter for up to 46 months.
OS Assessed From Start of 4-Week Run-In
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.
Measured: BL and weekly thereafter for up to 46 months.
Percentage of Participants With Disease Progression or Death as Assessed From the Start of 4-Week Run-In
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.
Measured: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression or death for up to 46 months.
PFS Assessed From the Start of 4-Week Run-In
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.
Measured: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression or death for up to 46 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 467 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652366
- Sponsor's protocol ID
- BO21128
- Other IDs
- 2007-003751-37
- Status last verified
- Jan 2015
- First submitted
- 1 Apr 2008
- Last updated
- 11 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT00652366
- Acronym / sponsor ID
- BO21128
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 467 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 3 Apr 2008 (estimated)
- Results
- Posted 11 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine, Erlotinib Standard Dose | Active comparator | Drug: Erlotinib, standard dose, Drug: GemcitabineParticipants 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. |
| Gemcitabine, Erlotinib Escalating Dose | Experimental | Drug: Erlotinib, escalating dose, Drug: GemcitabineParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erlotinib, escalating doseAlso: Tarceva100mg, PO, once daily, escalating to a maximum of 250mg, PO, once daily | Drug | Gemcitabine, Erlotinib Escalating Dose |
| Erlotinib, standard doseAlso: Tarceva100mg, PO, once daily | Drug | Gemcitabine, Erlotinib Standard Dose |
| Gemcitabine1000 mg/m2, IV, on days 1,8 and 15 of each 4 week cycle | Drug | Gemcitabine, Erlotinib Escalating Dose, Gemcitabine, Erlotinib Standard Dose |
Primary outcome
Percentage of Participants Who Died Assessed From Point of Randomization
Time frame: Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.
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.
OS Assessed From Point of Randomization
Time frame: Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.
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.
9 secondary outcomes
Percentage of Participants With Disease Progression or Death as Assessed From Point of Randomization
Time frame: Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.
PFS Assessed From Point of Randomization
Time frame: Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.
Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST
Time frame: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.
Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST
Time frame: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.
Percentage of Participants With SD (Maintained for at Least 8 Weeks) or CR or PR (Maintained for at Least 4 Weeks) According to RECIST
Time frame: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months.
Percentage of Participants Who Died as Assessed From Start of 4-Week Run-In
Time frame: BL and weekly thereafter for up to 46 months.
OS Assessed From Start of 4-Week Run-In
Time frame: BL and weekly thereafter for up to 46 months.
Percentage of Participants With Disease Progression or Death as Assessed From the Start of 4-Week Run-In
Time frame: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression or death for up to 46 months.
PFS Assessed From the Start of 4-Week Run-In
Time frame: BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression or death for up to 46 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
89 sites in 23 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erlotinib, escalating dose, Erlotinib, standard dose and Gemcitabine in people with Pancreatic Cancer, run by Hoffmann-La Roche at 89 sites in 23 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 89 sites in Germany, Australia, Italy, Belgium, Brazil and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Died Assessed From Point of Randomization (time frame: Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2015.