Pancreatic CancerPhase 2NCT00470535
Erlotinib in Treating Patients With Stage III or Stage IV Pancreatic Cancer
A Phase 2 study testing erlotinib hydrochloride, immunohistochemistry staining method and laboratory biomarker analysis in people with Pancreatic Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with stage III or stage IV pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- erlotinib hydrochloride, immunohistochemistry staining method and laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Sep 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Locally advanced inoperable or metastatic disease (stage III or IV disease)
- No more than 1 prior systemic therapy
- Patients who have not received 1 prior systemic therapy must meet 1 of the following criteria:
- Ineligible for or refused chemoradiotherapy AND has stage III disease
- Ineligible for or refused gemcitabine hydrochloride-based chemotherapy AND has stage IV disease
- No brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy > 3 months
- WBC > 3,000/mm³
- ANC > 1,500/mm³
- Platelet count > 100,000/mm³
- Bilirubin ≤ 2 mg/dL
- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN in patients with documented liver metastases)
- Creatinine < 1.5 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after completion of study therapy
- No uncontrolled comorbid illness that is likely to increase toxicity of the study drug or to interfere with toxicity evaluation
- No known allergy to the study drug or its excipients
- No symptomatic interstitial pulmonary disease
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior adjuvant therapy allowed provided it was completed at least 28 days prior to study entry
- No prior EGFR-inhibitor
- No concurrent drugs that are known to be strong inducers or inhibitors of the CYP450 enzyme system
- No concurrent Hypericum perforatum (St. John's wort)
- No concurrent investigational or commercial agents or therapies with the intent to treat the patient's malignancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
About this study
Official title: Phase II Study of Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Adenocarcinoma
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with stage III or stage IV pancreatic cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the progression-free survival (PFS) of patients with stage III or IV adenocarcinoma of the pancreas treated with erlotinib hydrochloride as first- or second-line therapy.
Secondary
- Determine the proportion of patients with a radiological response to this drug.
- Determine the overall survival of these patients.
- Determine the effect of this drug on quality of life in these patients.
- Correlate expression of EGFR, E-cadherin, P-cadherin, vimentin, cytokeratin, fibronectin, and ki67 in baseline tumor blocks and presence of K-ras mutations in baseline tumor biopsy specimens with response to this drug.
- Correlate smoking status with PFS in patients treated with this drug.
- Collect serum samples before, during, and after therapy for future serum proteomic studies and for development of profiles of responders to this drug.
OUTLINE: Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Patients complete a questionnaire about their smoking status at baseline. Patients also complete questionnaires about their quality of life every three weeks during study therapy and after completion of study therapy.
Blood samples are collected from patients at baseline and periodically during study for future serum proteomic research and for development of profiles of responders to erlotinib hydrochloride therapy. Paraffin-embedded tumor tissue from diagnostic tumor biopsies is assessed at baseline for expression of EGFR, E-cadherin, P-cadherin, vimentin, cytokeratin, fibronectin, and ki67 by immunohistochemical analysis. Tissue from surgical specimens in patients with prior resection is assessed for K-ras mutations by K-ras analysis.
After completion of study therapy, patients are followed for at least 6 months.
PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.
- Conditions
- Pancreatic Cancer
- Being tested
- erlotinib hydrochloride, immunohistochemistry staining method, laboratory biomarker analysis
- Keywords
- adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer
- 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 hydrochlorideDrug
Oral
immunohistochemistry staining methodOther
Correlative Study
laboratory biomarker analysisOther
Correlative Study
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Oral Erlotinib hydrochloride | Experimental | Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity Receives: Drug: erlotinib hydrochloride; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion
Measured: Every cycle for up to 52 weeks
Secondary outcomes (5)
Clinical Response (Complete and Partial Response) as Measured by RECIST Criteria
Measured: After every cycle
Median Overall Survival
Measured: After every cycle
Change in Quality of Life (QOL) as Measured by EORTC PAN26 Every 3 Weeks During Study Therapy and After Completion of Study Therapy
Measured: Every 3 weeks
Correlation of Smoking Status With Overall Survival
Measured: Every 3 weeks
Correlation of Response, QOL, and Survival With EGFR, E-cadherin, P-cadherin, Vimentin, Cytokeratin, ki67, and Fibronectin and With Other Prognostic Variables, Such as Age and Tumor Grade
Measured: At Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2007 (estimated)
- Study startJan 2007
- Primary completionJan 2009
- Study completionSep 2010
Why it stopped: This study was terminated earlier due to a phase III study that showed this drug inferior to sorafenib
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 Roswell Park Cancer InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renuka Iyer, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00470535
- Sponsor's protocol ID
- CDR0000543406
- Other IDs
- RPCI-I-87106
- Status last verified
- Jan 2017
- First submitted
- 3 May 2007
- Last updated
- 23 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Erlotinib (Tarceva®) in Patients With Advanced Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00470535
- Acronym / sponsor ID
- CDR0000543406
- Conditions
- Pancreatic Cancer
- Keywords
- adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated earlier due to a phase III study that showed this drug inferior to sorafenib
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 7 May 2007 (estimated)
- Results
- Posted 10 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with stage III or stage IV pancreatic cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the progression-free survival (PFS) of patients with stage III or IV adenocarcinoma of the pancreas treated with erlotinib hydrochloride as first- or second-line therapy.
Secondary
- Determine the proportion of patients with a radiological response to this drug.
- Determine the overall survival of these patients.
- Determine the effect of this drug on quality of life in these patients.
- Correlate expression of EGFR, E-cadherin, P-cadherin, vimentin, cytokeratin, fibronectin, and ki67 in baseline tumor blocks and presence of K-ras mutations in baseline tumor biopsy specimens with response to this drug.
- Correlate smoking status with PFS in patients treated with this drug.
- Collect serum samples before, during, and after therapy for future serum proteomic studies and for development of profiles of responders to this drug.
OUTLINE: Patients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Patients complete a questionnaire about their smoking status at baseline. Patients also complete questionnaires about their quality of life every three weeks during study therapy and after completion of study therapy.
Blood samples are collected from patients at baseline and periodically during study for future serum proteomic research and for development of profiles of responders to erlotinib hydrochloride therapy. Paraffin-embedded tumor tissue from diagnostic tumor biopsies is assessed at baseline for expression of EGFR, E-cadherin, P-cadherin, vimentin, cytokeratin, fibronectin, and ki67 by immunohistochemical analysis. Tissue from surgical specimens in patients with prior resection is assessed for K-ras mutations by K-ras analysis.
After completion of study therapy, patients are followed for at least 6 months.
PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Oral Erlotinib hydrochloride | Experimental | Drug: erlotinib hydrochloride, Other: immunohistochemistry staining method, Other: laboratory biomarker analysisPatients receive oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 hydrochlorideOral | Drug | Arm 1 - Oral Erlotinib hydrochloride |
| immunohistochemistry staining methodCorrelative Study | Other | Arm 1 - Oral Erlotinib hydrochloride |
| laboratory biomarker analysisCorrelative Study | Other | Arm 1 - Oral Erlotinib hydrochloride |
Primary outcome
Progression-free Survival
Time frame: Every cycle for up to 52 weeks
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion
5 secondary outcomes
Clinical Response (Complete and Partial Response) as Measured by RECIST Criteria
Time frame: After every cycle
Median Overall Survival
Time frame: After every cycle
Change in Quality of Life (QOL) as Measured by EORTC PAN26 Every 3 Weeks During Study Therapy and After Completion of Study Therapy
Time frame: Every 3 weeks
Correlation of Smoking Status With Overall Survival
Time frame: Every 3 weeks
Correlation of Response, QOL, and Survival With EGFR, E-cadherin, P-cadherin, Vimentin, Cytokeratin, ki67, and Fibronectin and With Other Prognostic Variables, Such as Age and Tumor Grade
Time frame: At Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- 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.
Renuka Iyer, MD principal investigator
Roswell Park Cancer Institute
1 site 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 hydrochloride, immunohistochemistry staining method and laboratory biomarker analysis in people with Pancreatic Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 10 Dec 2014). 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?
Progression-free Survival (time frame: Every cycle for up to 52 weeks). 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 23 Feb 2017.