Pancreatic CancerPhase 2NCT00225784
Cetuximab, Radiotherapy and Twice Weekly Gemcitabine to Treat Pancreatic Cancer
A Phase 2 study testing Cetuximab/Gemcitabine and Radiotherapy in people with Pancreatic Cancer, run by Dartmouth-Hitchcock Medical Center.
Trial summary
This study is designed to establish the safety and efficacy of a combination of Erbitux (cetuximab)/Gemzar (gemcitabine)/radiation in patients with pancreatic cancer. 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?
- Cetuximab/Gemcitabine and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Feb 2005to Sep 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
- Histologic proof of pancreatic adenocarcinoma
- Clinical stage I, II, or III disease
- Radiographically measurable disease
- Tumor tissue for epidermal growth factor receptor (EGFR) status by immunohistochemistry
- Signed protocol consent
- Karnofsky performance status of at least 70%
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- Age > or = to 18 years
- Patients must either not be of child bearing potential or have a negative pregnancy test within 72 hours of treatment.
- Absolute neutrophil count (ANC) > 1500; platelets > 100,000/ul.
- Creatinine < 1.5 x upper limit of normal (ULN)
- Bilirubin < 1.5 x ULN; AST < 2.5 x ULN.
Who cannot join
- Acute hepatitis or known HIV
- Active or uncontrolled infection
- Significant history of cardiac disease
- Prior therapy which affects or targets the EGF pathway
- Prior severe infusion reaction to a monoclonal antibody
- Any concurrent chemotherapy not indicated in the study protocol or any other investigational agents
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- Any previous chemotherapy or abdominal or pelvic radiotherapy
- No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or malignancy for which the patient has been disease free for five years.
- Any severe pre-existing medical or psychiatric condition, which, in the opinion of the attending physician, will interfere with safe and appropriate treatment and follow-up on study
About this study
Official title: A Phase II Trial of Cetuximab, Radiotherapy and Twice Weekly Gemcitabine in Patients With Adenocarcinoma of the Pancreas
This study is designed to establish the safety and efficacy of a combination of Erbitux (cetuximab)/Gemzar (gemcitabine)/radiation in patients with pancreatic cancer.
Read the detailed description
The study treatment for this protocol is
- Loading dose of Cetuximab 400 mg/m2
- Weekly Cetuximab 250 mg/m2
- Bi-weekly Gemcitabine 50 mg/m2
- Daily Radiation for 28 fractions
- CT scan four weeks after completion of treatment
- Evaluation by surgeon for resectability
- Conditions
- Pancreatic Cancer
- Being tested
- Cetuximab/Gemcitabine, Radiotherapy
- Keywords
- Stage I, II, III pancreatic adenocarcinoma, Radiographically measurable disease
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetuximab/GemcitabineDrug
Also called Erbitux
Once weekly Cetuximab, twice weekly Gemcitabine for six weeks
RadiotherapyProcedure or surgery
Daily radiotherapy for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Cetuximab, Gemcitabine, RT | Experimental | weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy Receives: Drug: Cetuximab/Gemcitabine; Procedure: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response of Tumor by RECIST 1.0 Criteria
Per RECIST Criteria (v. 1.0) and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of the longest diameter (SLD)of target lesions at baseline; Progressive Disease (PD), >=20% increase in the SLD of target lesions at baseline; Stable Disease (SD), Neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD.
Measured: one month post-therapy
Secondary outcomes (6)
Number of Participants Assessed for Adverse Events
Adverse events assessed using Common Terminology Criteria for Adverse Events version 3.0
Measured: Participants were followed during treatment and for 30 days after completion of treatment
Number of Participants Determined to be Resectable (Eligible for Surgery)After Completion of Therapy
Tumor resectability is based on CT scan and as defined by the American Hepato-Pancreato-Biliary Association Convened Consensus Conference on Resectable and Borderline Resectable Pancreatic Cancer (Callery MP, et al. Ann Surg Oncol 2009; 16:1727-1733): no evidence of superior mesenteric vein (SMV) or portal vein (PV)abutment, distortion, tumor thrombus, or venous encasement, and clear fat planes around celiac axis (CA), hepatic artery (HA), and superior mesenteric artery (SMA).
Measured: 1 month after completion of treatment
Role of Epidermal Growth Factor Receptor (EGFR) Status in Response to Treatment.
Tumor was assessed for EGFR status by immunohistochemistry. EGFR positive and EGRF negative tumor types were evaluated and compared for response to treatment.
Measured: One month post-therapy
Disease-Free Survival After Therapy
Time to disease progression after therapy.
Measured: Five years post treatment
Overall Length of Survival After Therapy
Length of survival after therapy in all participants enrolled.
Measured: Five years post treatment
Pattern of Failure After Therapy
Local recurrence, distant recurrence, or both.
Measured: Five years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionFeb 2010
- Study completionSep 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 Dartmouth-Hitchcock Medical CenterThe 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J Marc Pipas, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225784
- Sponsor's protocol ID
- DMS 0432
- Status last verified
- Oct 2011
- First submitted
- 22 Sep 2005
- Last updated
- 16 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Cetuximab, Radiotherapy and Twice Weekly Gemcitabine in Patients With Adenocarcinoma of the Pancreas
- ClinicalTrials.gov ID
- NCT00225784
- Acronym / sponsor ID
- DMS 0432
- Conditions
- Pancreatic Cancer
- Keywords
- Stage I, II, III pancreatic adenocarcinoma, Radiographically measurable disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Feb 2010 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 26 Sep 2005 (estimated)
- Results
- Posted 18 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to establish the safety and efficacy of a combination of Erbitux (cetuximab)/Gemzar (gemcitabine)/radiation in patients with pancreatic cancer.
Detailed description
The study treatment for this protocol is
- Loading dose of Cetuximab 400 mg/m2
- Weekly Cetuximab 250 mg/m2
- Bi-weekly Gemcitabine 50 mg/m2
- Daily Radiation for 28 fractions
- CT scan four weeks after completion of treatment
- Evaluation by surgeon for resectability
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cetuximab, Gemcitabine, RT | Experimental | Drug: Cetuximab/Gemcitabine, Procedure: Radiotherapyweekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologic proof of pancreatic adenocarcinoma
- Clinical stage I, II, or III disease
- Radiographically measurable disease
- Tumor tissue for epidermal growth factor receptor (EGFR) status by immunohistochemistry
- Signed protocol consent
Key exclusion criteria (9 listed)
- Acute hepatitis or known HIV
- Active or uncontrolled infection
- Significant history of cardiac disease
- Prior therapy which affects or targets the EGF pathway
- Prior severe infusion reaction to a monoclonal antibody
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 |
|---|---|---|
| Cetuximab/GemcitabineAlso: ErbituxOnce weekly Cetuximab, twice weekly Gemcitabine for six weeks | Drug | Cetuximab, Gemcitabine, RT |
| RadiotherapyDaily radiotherapy for 28 days | Procedure or surgery | Cetuximab, Gemcitabine, RT |
Primary outcome
Objective Response of Tumor by RECIST 1.0 Criteria
Time frame: one month post-therapy
Per RECIST Criteria (v. 1.0) and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of the longest diameter (SLD)of target lesions at baseline; Progressive Disease (PD), >=20% increase in the SLD of target lesions at baseline; Stable Disease (SD), Neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD.
6 secondary outcomes
Number of Participants Assessed for Adverse Events
Time frame: Participants were followed during treatment and for 30 days after completion of treatment
Number of Participants Determined to be Resectable (Eligible for Surgery)After Completion of Therapy
Time frame: 1 month after completion of treatment
Role of Epidermal Growth Factor Receptor (EGFR) Status in Response to Treatment.
Time frame: One month post-therapy
Disease-Free Survival After Therapy
Time frame: Five years post treatment
Overall Length of Survival After Therapy
Time frame: Five years post treatment
Pattern of Failure After Therapy
Time frame: Five years post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
- 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.
J Marc Pipas, MD principal investigator
Dartmouth-Hitchcock Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab/Gemcitabine and Radiotherapy in people with Pancreatic Cancer, run by Dartmouth-Hitchcock Medical Center.
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 11 inclusion and 9 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 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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 18 Apr 2013). 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?
Objective Response of Tumor by RECIST 1.0 Criteria (time frame: one month post-therapy). 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 16 Jul 2014.