Pancreatic CancerPhase 2NCT00461708
A Study of Tarceva (Erlotinib) in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas: Relationship Between Skin Toxicity and Survival
A Phase 2 study testing Erlotinib and Gemcitabine in people with Pancreatic Cancer, run by Hoffmann-La Roche at 29 sites in Spain.
Trial summary
This single arm study will evaluate the relationship between the skin toxicity of Tarceva in combination with gemcitabine, and survival, in patients with advanced and/or metastatic pancreatic cancer. All patients will receive gemcitabine 100mg/m2 i.v. weekly; Tarceva will be administered 100mg po per day. 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 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
- 153 participants
- Where
- 29 sitesSpain
- Study dates
- May 2007to Nov 2010
- 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;
- locally advanced and/or metastatic pancreatic cancer (stage III or IV);
- Karnofsky performance Status of >=60%.
Who cannot join
- local(stage IA to IIB) pancreatic cancer;
- <=6 months since last adjuvant chemotherapy;
- previous systemic therapy for metastatic pancreatic cancer;
- other primary tumor within last 5 years (except for adequately treated cancer in situ of cervix, or basal cell skin cancer);
- clinically significant cardiovascular disease.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Spain29 sites
Study site
A Coruña, La Coruña, 15006
Study site
Alcorcón, Madrid, 28922
Study site
Alcoy, Alicante, 03804
Study site
Barcelona, Barcelona, 08227
Study site
Barcelona, Barcelona, 08906
Study site
Barcelona, Barcelona, 08907
Study site
Barcelona, Barcelona, 08916
Study site
Córdoba, Cordoba, 14004
Study site
Elche, Alicante, 03203
Study site
Girona, Girona, 17007
Study site
Granada, Granada, 18014
Study site
Guadalajara, Guadalajara, 19002
Study site
Jaén, Jaen, 23007
Study site
Lleida, Lerida, 25198
Study site
Lugo, Lugo, 27004
Study site
Madrid, Madrid, 28040
Study site
Madrid, Madrid, 28041
Study site
Manresa, Barcelona, 08243
Study site
Murcia, Murcia, 30008
Study site
Murcia, Murcia, 30120
Study site
Navarra, Navarre, 31008
Study site
Palma de Mallorca, Balearic Islands, 07198
Study site
Pontevedra, Pontevedra, 36002
Study site
Sabadell, Barcelona, Barcelona, 08208
Study site
Sagunto, Valencia, 46520
Study site
Santander, Cantabria, 39008
Study site
Seville, Sevilla, 41013
Study site
Valencia, Valencia, 41014
Study site
Zaragoza, Zaragoza, 50009
About this study
Official title: An Open Label Study of Tarceva in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas : Relationship Between Skin Rash and Survival
This single arm study will evaluate the relationship between the skin toxicity of Tarceva in combination with gemcitabine, and survival, in patients with advanced and/or metastatic pancreatic cancer. All patients will receive gemcitabine 100mg/m2 i.v. weekly; Tarceva will be administered 100mg po per day. 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, 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.
ErlotinibDrug
Also called Tarceva
100 mg, PO, once per day
GemcitabineDrug
1000 mg/m2, IV, on Days 1, 8 and 15 in 4-week cycles
| Study group | Role | What they receive |
|---|---|---|
| Rash, Grade <2 | Experimental | Participants with a rash graded less than (<) 2 according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version (v.) 3.0 received erlotinib, 100 milligrams (mg), orally (PO), once per day until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. Participants also received gemcitabine, 1000 mg per (/) square meter (m^2), intravenously (IV), over 30 minutes on Days 1, 8 and 15 in 4-week cycles until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. Receives: Drug: Erlotinib; Drug: Gemcitabine |
| Rash, Grade ≥2 | Experimental | Participants with a rash graded greater than or equal to (≥) 2 according to the NCI-CTC v. 3.0 received erlotinib, 100 mg, PO, once per day until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 in 4-week cycles until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. Receives: Drug: Erlotinib; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Died During the Study
Measured: Enrollment through Cycle 24 (4-week cycles), up to 24 months.
Overall Survival (OS) During the Study
OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.
Measured: Enrollment through Cycle 24 (4-week cycles), up to 24 months.
Secondary outcomes (8)
Number of Participants Who Died at 6 Months
Measured: Enrollment through Cycle 6 (4-week cycles), up to 6 months.
OS At 6 Months
OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.
Measured: Enrollment through Cycle 6 (4-week cycles), up to 6 months.
Number of Participants Who Died During the Study By Rash Grade
Measured: Enrollment through Cycle 24 (4-week cycles), up to 24 months.
OS By Rash Grade
OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.
Measured: Enrollment through Cycle 24 (4-week cycles), up to 24 months.
Number of Participants With Disease Progression or Death
Progression-free survival (PFS) was defined as the time from the date of enrollment to the date of document disease progression or death due to any cause. As per Response Evaluation Criteria in Solid Tumors (RECIST) V 1.0, progressive disease (PD) was defined for target lesions (TLs) as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment, and for non-target lesions (NTLs) as unequivocal progression of NTLs. Participants whose last recorded status was not PD or death were censored.
Measured: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.
PFS
The time, in months, from enrollment to PFS event. Participants whose last recorded status was not progression or death were censored. PFS was estimated using Kaplan-Meier methodology.
Measured: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months
Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST
As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR.
Measured: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.
Percentage of Participants With Disease Control According to RECIST
Disease control was defined as BOR of CR, PR, or stable disease (SD). As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a 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. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD was defined as the persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR.
Measured: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startMay 2007
- Primary completionNov 2010
- Study completionNov 2010
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 153 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
- NCT00461708
- Sponsor's protocol ID
- ML20296
- Status last verified
- Sep 2015
- First submitted
- 17 Apr 2007
- Last updated
- 15 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study of Tarceva in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas : Relationship Between Skin Rash and Survival
- ClinicalTrials.gov ID
- NCT00461708
- Acronym / sponsor ID
- ML20296
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 18 Apr 2007 (estimated)
- Results
- Posted 15 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single arm study will evaluate the relationship between the skin toxicity of Tarceva in combination with gemcitabine, and survival, in patients with advanced and/or metastatic pancreatic cancer. All patients will receive gemcitabine 100mg/m2 i.v. weekly; Tarceva will be administered 100mg po per day. 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rash, Grade <2 | Experimental | Drug: Erlotinib, Drug: GemcitabineParticipants with a rash graded less than (<) 2 according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version (v.) 3.0 received erlotinib, 100 milligrams (mg), orally (PO), once per day until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. Participants also received gemcitabine, 1000 mg per (/) square meter (m^2), intravenously (IV), over 30 minutes on Days 1, 8 and 15 in 4-week cycles until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. |
| Rash, Grade ≥2 | Experimental | Drug: Erlotinib, Drug: GemcitabineParticipants with a rash graded greater than or equal to (≥) 2 according to the NCI-CTC v. 3.0 received erlotinib, 100 mg, PO, once per day until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 in 4-week cycles until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. |
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;
- locally advanced and/or metastatic pancreatic cancer (stage III or IV);
- Karnofsky performance Status of >=60%.
Key exclusion criteria (5 listed)
- local(stage IA to IIB) pancreatic cancer;
- <=6 months since last adjuvant chemotherapy;
- previous systemic therapy for metastatic pancreatic cancer;
- other primary tumor within last 5 years (except for adequately treated cancer in situ of cervix, or basal cell skin cancer);
- clinically significant cardiovascular disease.
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 |
|---|---|---|
| ErlotinibAlso: Tarceva100 mg, PO, once per day | Drug | Rash, Grade <2, Rash, Grade ≥2 |
| Gemcitabine1000 mg/m2, IV, on Days 1, 8 and 15 in 4-week cycles | Drug | Rash, Grade <2, Rash, Grade ≥2 |
Primary outcome
Number of Participants Who Died During the Study
Time frame: Enrollment through Cycle 24 (4-week cycles), up to 24 months.
Overall Survival (OS) During the Study
Time frame: Enrollment through Cycle 24 (4-week cycles), up to 24 months.
OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.
8 secondary outcomes
Number of Participants Who Died at 6 Months
Time frame: Enrollment through Cycle 6 (4-week cycles), up to 6 months.
OS At 6 Months
Time frame: Enrollment through Cycle 6 (4-week cycles), up to 6 months.
Number of Participants Who Died During the Study By Rash Grade
Time frame: Enrollment through Cycle 24 (4-week cycles), up to 24 months.
OS By Rash Grade
Time frame: Enrollment through Cycle 24 (4-week cycles), up to 24 months.
Number of Participants With Disease Progression or Death
Time frame: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.
PFS
Time frame: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months
Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST
Time frame: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.
Percentage of Participants With Disease Control According to RECIST
Time frame: Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 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
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erlotinib and Gemcitabine in people with Pancreatic Cancer, run by Hoffmann-La Roche at 29 sites in Spain.
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 5 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 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Spain. 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 15 Oct 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?
Number of Participants Who Died During the Study (time frame: Enrollment through Cycle 24 (4-week cycles), up to 24 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 15 Oct 2015.