Pancreatic CancerPhase 2NCT00424827
A Trial of Chemo & Radiation Therapy for Pancreatic Cancer
A Phase 2 study testing Gemcitabine/Fluorouracil with External Beam Radiation in people with Pancreatic Cancer, run by University of Massachusetts, Worcester.
Trial summary
This is an open-label, non-randomized, combination study of cetuximab, gemcitabine, 5-FU, and external beam radiotherapy in patients with locally advanced, non-metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Gemcitabine/Fluorouracil with External Beam Radiation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Dec 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological confirmation of pancreatic adenocarcinoma is required.
- Only patients with unresectable, non-metastatic tumors are eligible.
- Documentation of disease extent by endoscopic ultrasound and either laparotomy or laparoscopy must be performed within 42 days of registration.
- All patients will also be assessed by chest x-ray and abdominal-pelvic CT scan.
- Confirmation of palliative surgical bypass at the time of laparotomy or whether a biliary stent was placed will be requested.
- Disease must be locoregional and not amenable to surgery based on one or more of the following criteria:
Show all 33Show fewer
- size of pancreatic tumor > 5 cm.
- lymph nodes (bulky, > 2 cm, but within a radiation port)
- vascular involvement or impingement of major vessels (superior mesenteric artery, superior mesenteric vein, portal vein, hepatic artery).
- invasion into the adjacent structures.
- Patients with either measurable or evaluable disease are eligible.
- Patients with evidence of peritoneal seeding by malignancy are not eligible for the study.
- Patients with other evidence of metastatic disease are not eligible.
- Patients with concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, are ineligible.
- Patients with any other malignancy within 5 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, are ineligible.
- Patients may not have had prior therapy for carcinoma of the pancreas, nor prior abdominal radiation therapy.
- Age > 18 years.
- CTC performance status < 2.
- No myocardial infarction in the past six months.
- No major surgery in the past two weeks.
- No uncontrolled serious medical or psychiatric illness.
- Required Initial Laboratory Data:
- Total bilirubin < 2.0 mg/dl
- AST < 3x upper limits of normal.
- Serum creatinine < 2.0 mg/dl
- WBC > 3,000/mm3 (ANC>1500/mm3)
- Platelets > 100,000 mm3
- CA 19-9
- Required Diagnostic procedures:
- Chest X-ray
- Abdominal pelvic CT scan
- EUS
- Staging laparoscopy or staging laparotomy
Who cannot join
- Enrollment in this trial will be limited to patients for whom protocol therapy is safe and appropriate. Physicians should consider the risks and benefits of therapy together with all relevant medical and other considerations in deciding whether this protocol is appropriate for a particular patient. Specific considerations include:
- Psychiatric illness which would prevent the patient from giving informed consent.
- Serious medical illness such as uncontrolled infection, severe cardiovascular disease including recent (< 6 months) myocardial infarction or uncontrolled congestive heart failure, or other serious illness which would limit anticipated survival to < 12 weeks.
- Protocol treatment would pose significant risk to an unborn child. Pregnant women should not be enrolled, and women of child-bearing age should be strongly encouraged to practice effective birth control during and for three months after the trial.
- Inability to swallow medication. Patients should have adequate, unassisted oral intake.
About this study
Official title: A Phase II Trial of Cetuximab, Gemcitabine, 5-Fluorouracil and Radiation Therapy in Locally Advanced Non-metastatic Pancreatic Adenocarcinoma
This is an open-label, non-randomized, combination study of cetuximab, gemcitabine, 5-FU, and external beam radiotherapy in patients with locally advanced, non-metastatic pancreatic cancer.
Read the detailed description
During cycle I (chemoradiation), gemcitabine (200 mg/m2) and cetuximab 400mg/m2 initial dose followed by 250mg/m2 IV weekly will be given with continuous infusion 5-FU (200 mg/m2/day) delivered 5 of every 7 days and concurrent external beam radiation therapy. Cetuximab, gemcitabine and 5-FU will begin on the first week of external beam radiotherapy and will continue throughout the course of external beam radiation therapy, and will be discontinued following the conclusion of external beam radiation therapy. All patients will have a central venous access device placed to facilitate chemotherapy administration.
During cycles 2 through 5 (chemotherapy), gemcitabine will be administered at a dose of 1000 mg/m2 over 30 minutes followed by cetuximab at a dose of 250mg/m2 over 30 minutes weekly for 3 weeks followed by one-week rest for four cycles.
- Conditions
- Pancreatic Cancer
- Being tested
- Gemcitabine/Fluorouracil with External Beam Radiation
- Keywords
- pancreatic cancer, gemcitabine, 5-FU, cetuximab, radiation
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine/Fluorouracil with External Beam RadiationDrug
Also called EGFR Expression; Cetuximab & Radiosensitization of Cetuximab
This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma.
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine/Fluorouracil with External Beam Radiation | Experimental | This protocol will assess the antitumor activity of Gemcitabine/Fluorouracil with External Beam Radiation in patients with non-metastatic, locally advanced pancreatic carcinoma. Receives: Drug: Gemcitabine/Fluorouracil with External Beam Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival of Patients With Locally Advanced Pancreatic Cancer Treated With Concurrent Gemcitabine, 5-FU, Cetuximab and External Beam Radiation Therapy.
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 lesions
Measured: 1-year
Secondary outcomes (4)
Biomarker Response to Chemoradiation Therapy
20% decrease in biomarker (CA19-9) from baseline
Measured: 1-year
Resection Rate
Measured: 1-Year
Overall Survival
Measured: Up to 2 years
Toxicity Associated With This Regimen.
Measured: 1-Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2007 (estimated)
- Study startJun 2006
- Primary completionDec 2014
- Study completionDec 2014
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 University of Massachusetts, WorcesterThe 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Venu Bathini, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424827
- Sponsor's protocol ID
- UM200602
- Status last verified
- May 2017
- First submitted
- 18 Jan 2007
- Last updated
- 1 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Cetuximab, Gemcitabine, 5-Fluorouracil and Radiation Therapy in Locally Advanced Non-metastatic Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00424827
- Acronym / sponsor ID
- UM200602
- Conditions
- Pancreatic Cancer
- Keywords
- pancreatic cancer, gemcitabine, 5-FU, cetuximab, radiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Jan 2007 (estimated)
- Results
- Posted 1 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, non-randomized, combination study of cetuximab, gemcitabine, 5-FU, and external beam radiotherapy in patients with locally advanced, non-metastatic pancreatic cancer.
Detailed description
During cycle I (chemoradiation), gemcitabine (200 mg/m2) and cetuximab 400mg/m2 initial dose followed by 250mg/m2 IV weekly will be given with continuous infusion 5-FU (200 mg/m2/day) delivered 5 of every 7 days and concurrent external beam radiation therapy. Cetuximab, gemcitabine and 5-FU will begin on the first week of external beam radiotherapy and will continue throughout the course of external beam radiation therapy, and will be discontinued following the conclusion of external beam radiation therapy. All patients will have a central venous access device placed to facilitate chemotherapy administration.
During cycles 2 through 5 (chemotherapy), gemcitabine will be administered at a dose of 1000 mg/m2 over 30 minutes followed by cetuximab at a dose of 250mg/m2 over 30 minutes weekly for 3 weeks followed by one-week rest for four cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine/Fluorouracil with External Beam Radiation | Experimental | Drug: Gemcitabine/Fluorouracil with External Beam RadiationThis protocol will assess the antitumor activity of Gemcitabine/Fluorouracil with External Beam Radiation in patients with non-metastatic, locally advanced pancreatic carcinoma. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Histological confirmation of pancreatic adenocarcinoma is required.
- Only patients with unresectable, non-metastatic tumors are eligible.
- Documentation of disease extent by endoscopic ultrasound and either laparotomy or laparoscopy must be performed within 42 days of registration.
- All patients will also be assessed by chest x-ray and abdominal-pelvic CT scan.
- Confirmation of palliative surgical bypass at the time of laparotomy or whether a biliary stent was placed will be requested.
Key exclusion criteria (5 listed)
- Enrollment in this trial will be limited to patients for whom protocol therapy is safe and appropriate. Physicians should consider the risks and benefits of therapy together with all relevant medical and other considerations in deciding whether this protocol is appropriate for a particular patient. Specific considerations include:
- Psychiatric illness which would prevent the patient from giving informed consent.
- Serious medical illness such as uncontrolled infection, severe cardiovascular disease including recent (< 6 months) myocardial infarction or uncontrolled congestive heart failure, or other serious illness which would limit anticipated survival to < 12 weeks.
- Protocol treatment would pose significant risk to an unborn child. Pregnant women should not be enrolled, and women of child-bearing age should be strongly encouraged to practice effective birth control during and for three months after the trial.
- Inability to swallow medication. Patients should have adequate, unassisted oral intake.
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 |
|---|---|---|
| Gemcitabine/Fluorouracil with External Beam RadiationAlso: EGFR Expression; Cetuximab & Radiosensitization of CetuximabThis protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma. | Drug | Gemcitabine/Fluorouracil with External Beam Radiation |
Primary outcome
Progression-free Survival of Patients With Locally Advanced Pancreatic Cancer Treated With Concurrent Gemcitabine, 5-FU, Cetuximab and External Beam Radiation Therapy.
Time frame: 1-year
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 lesions
4 secondary outcomes
Biomarker Response to Chemoradiation Therapy
Time frame: 1-year
Resection Rate
Time frame: 1-Year
Overall Survival
Time frame: Up to 2 years
Toxicity Associated With This Regimen.
Time frame: 1-Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 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.
Venu Bathini, MD principal investigator
University of Massachusetts, Worcester
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine/Fluorouracil with External Beam Radiation in people with Pancreatic Cancer, run by University of Massachusetts, Worcester.
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 33 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 1 Jun 2017. 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 1 Jun 2017). 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 of Patients With Locally Advanced Pancreatic Cancer Treated With Concurrent Gemcitabine, 5-FU, Cetuximab and External Beam Radiation Therapy. (time frame: 1-year). 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 1 Jun 2017.