Pancreatic CancerPhase 2NCT00336700
A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer
A Phase 2 study testing Gemcitabine and Erlotinib in people with Pancreatic Cancer, run by Herbert J. Zeh, III MD, FACS at 1 site in United States.
Trial summary
Study Hypothesis: To estimate time to recurrence in pancreatic cancer patients treated with adjuvant erlotinib and gemcitabine. Combination therapy will be given for 4 months followed by single agent erlotinib for a total of 12 months. 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?
- Gemcitabine and Erlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Nov 2011
- 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
- Patients with potentially resectable pancreatic cancer (including ampullary cancer), prior to or after surgery will be accrued to this study.
- Patients who sign consent prior to surgery must have appropriate diagnostic imaging and be evaluated by one of the surgical co-investigators as having resectable disease, and probable pancreatic adenocarcinoma.
- Patients, who sign consent after surgery, must have adenocarcinoma of the pancreas with negative surgical margins.
- Adjuvant therapy should start within 10 weeks of surgery
- Age 18 years or older
- ECOG performance status of 0 - 1 (see Appendix A)
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- Ability to take oral medications without difficulty
- Adequate bone marrow function as evidenced by an absolute neutrophil content (ANC) > 1500/mL and platelet count > 100,000/mL
- Adequate renal function as evidenced by serum creatinine within institutional limits or creatinine clearance > 50 ml/minute if above upper institutional limits (ULN)
- Adequate hepatic function as evidenced by ALT and total bilirubin within 2 times ULN.
- Provision of written informed consent.
- Men and women of childbearing potential must be willing to practice acceptable methods of birth control to prevent pregnancy.
Who cannot join
- Positive margins on post operative surgical specimen or evidence of metastatic disease (positive retroperitoneal margin is allowed)
- Biliary tree cancers are not allowed (Note: Ampullary cancer allowed).
- Known severe hypersensitivity to erlotinib or any of the excipients of these products
- Any prior treatment with radiation therapy or chemotherapy or vaccines for pancreatic cancer.
- Other coexisting malignancies or malignancies diagnosed within the last 3 years, with the exception of basal cell carcinoma or squamous cell carcinoma of the skin or cervical cancer in situ.
- Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St. John's Wort. Other agents which inhibit CYP3A4 may be used with caution (Appendix B)
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- Treatment with a non-approved or investigational drug prior to treatment.
- Incomplete healing from previous oncologic or other major surgery.
- Pregnancy or breast feeding (women of childbearing potential).
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Cancer Centers Network
Pittsburgh, Pennsylvania, 15232
About this study
Study Hypothesis: To estimate time to recurrence in pancreatic cancer patients treated with adjuvant erlotinib and gemcitabine. Combination therapy will be given for 4 months followed by single agent erlotinib for a total of 12 months.
Read the detailed description
PATIENT POPULATION Resected pancreatic cancer patients (R0 resection) within 10 weeks of surgery will be eligible, provided that they meet standard eligibility criteria.
STUDY DESIGN Phase II, open-label trial of erlotinib and gemcitabine. SAFETY PLAN Safety as assessed by CTCAE 3.0 STUDY TREATMENT Erlotinib 150 mg/day x 12 months. (oral) Gemcitabine 1500 mg/m2 IV over 150 minutes q 2 weeks x 4 months Patients will be monitored with serial CT scans for the first 2 years after completion of therapy.
Clinical Practice: Therapy will be administered as an outpatient. Primary Evaluations: Time to recurrence CONCOMITANT THERAPY AND CLINICAL PRACTICE No other anti-cancer therapy will be allowed while on study.
- Conditions
- Pancreatic Cancer
- Being tested
- Gemcitabine, Erlotinib
- Keywords
- Pancreas, Cancer, Pancreatic
- Medical subject headings
- Pancreatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar
1500mg/m2 IV over 150 min IV q 2 weeks 4 months
ErlotinibDrug
Also called Tarceva
150 mg/d Daily, oral 12 months
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine and Erlotinib | Experimental | Erlotinib (oral) 150 mg/day x 12 months Gemcitabine 1500 mg/m2 IV over 150 minutes q 2 weeks x 4 months Receives: Drug: Gemcitabine; Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Free Survival (RFS)
The time interval between day 1, cycle 1, of adjuvant treatment to the first date of radiologic recurrence or death.
Measured: Up to 60 months
1-year Recurrence Free Survival (RFS)
Measured: Up to 60 months
2-year Recurrence Free Survival (RFS)
Measured: Up to 60 months
Secondary outcomes (3)
Estimated 1&2 Year Overall Survival (OS)
Time from from date of first study therapy to to death from any cause.
Measured: Up to 60 months
Percentage of Participants With Expression of Epidermal Growth Factor Receptor (EGFR)
Percentage of participants with expression of epidermal growth factor receptor (EGFR) expression in the resected tumors was assessed by fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC).
Measured: Up to 60 months
KRAS Mutational Status
KRAS mutation status in resected tumor specimens.
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionOct 2011
- Study completionNov 2011
Why it stopped: Study published November 2010 and no further work will be done
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.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herbert J. Zeh, III MD, FACS
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor-investigator, Herbert J. Zeh, III MD, FACS, University of Pittsburgh
- Investigators
- Herb Zeh, M.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336700
- Sponsor's protocol ID
- 06-016
- Status last verified
- Jul 2016
- First submitted
- 12 Jun 2006
- Last updated
- 19 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00336700
- Acronym / sponsor ID
- 06-016
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreas, Cancer, Pancreatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study published November 2010 and no further work will be done
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Herbert J. Zeh, III MD, FACSUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jun 2006
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 14 Jun 2006 (estimated)
- Results
- Posted 19 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Hypothesis: To estimate time to recurrence in pancreatic cancer patients treated with adjuvant erlotinib and gemcitabine. Combination therapy will be given for 4 months followed by single agent erlotinib for a total of 12 months.
Detailed description
PATIENT POPULATION Resected pancreatic cancer patients (R0 resection) within 10 weeks of surgery will be eligible, provided that they meet standard eligibility criteria.
STUDY DESIGN Phase II, open-label trial of erlotinib and gemcitabine. SAFETY PLAN Safety as assessed by CTCAE 3.0 STUDY TREATMENT Erlotinib 150 mg/day x 12 months. (oral) Gemcitabine 1500 mg/m2 IV over 150 minutes q 2 weeks x 4 months Patients will be monitored with serial CT scans for the first 2 years after completion of therapy.
Clinical Practice: Therapy will be administered as an outpatient. Primary Evaluations: Time to recurrence CONCOMITANT THERAPY AND CLINICAL PRACTICE No other anti-cancer therapy will be allowed while on study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine and Erlotinib | Experimental | Drug: Gemcitabine, Drug: ErlotinibErlotinib (oral) 150 mg/day x 12 months Gemcitabine 1500 mg/m2 IV over 150 minutes q 2 weeks x 4 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with potentially resectable pancreatic cancer (including ampullary cancer), prior to or after surgery will be accrued to this study.
- Patients who sign consent prior to surgery must have appropriate diagnostic imaging and be evaluated by one of the surgical co-investigators as having resectable disease, and probable pancreatic adenocarcinoma.
- Patients, who sign consent after surgery, must have adenocarcinoma of the pancreas with negative surgical margins.
- Adjuvant therapy should start within 10 weeks of surgery
- Age 18 years or older
Key exclusion criteria (11 listed)
- Positive margins on post operative surgical specimen or evidence of metastatic disease (positive retroperitoneal margin is allowed)
- Biliary tree cancers are not allowed (Note: Ampullary cancer allowed).
- Known severe hypersensitivity to erlotinib or any of the excipients of these products
- Any prior treatment with radiation therapy or chemotherapy or vaccines for pancreatic cancer.
- Other coexisting malignancies or malignancies diagnosed within the last 3 years, with the exception of basal cell carcinoma or squamous cell carcinoma of the skin or cervical cancer in situ.
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 |
|---|---|---|
| GemcitabineAlso: Gemzar1500mg/m2 IV over 150 min IV q 2 weeks 4 months | Drug | Gemcitabine and Erlotinib |
| ErlotinibAlso: Tarceva150 mg/d Daily, oral 12 months | Drug | Gemcitabine and Erlotinib |
Primary outcome
Recurrence Free Survival (RFS)
Time frame: Up to 60 months
The time interval between day 1, cycle 1, of adjuvant treatment to the first date of radiologic recurrence or death.
1-year Recurrence Free Survival (RFS)
Time frame: Up to 60 months
2-year Recurrence Free Survival (RFS)
Time frame: Up to 60 months
3 secondary outcomes
Estimated 1&2 Year Overall Survival (OS)
Time frame: Up to 60 months
Percentage of Participants With Expression of Epidermal Growth Factor Receptor (EGFR)
Time frame: Up to 60 months
KRAS Mutational Status
Time frame: Up to 60 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
- 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.
Herb Zeh, M.D. principal investigator
University of Pittsburgh
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 Gemcitabine and Erlotinib in people with Pancreatic Cancer, run by Herbert J. Zeh, III MD, FACS 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?
The sponsor lists 12 inclusion and 11 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: stopped early, as of the sponsor's last update on 19 Sep 2016. 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 19 Sep 2016). 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?
Recurrence Free Survival (RFS) (time frame: Up to 60 months). The study lists 3 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 19 Sep 2016.