Pancreatic CancerPhase 2NCT00338039
Induction Cetuximab (IM-C225), Gemcitabine, and Oxaliplatin in Pancreatic Cancer Patients
A Phase 2 study testing Cetuximab, Gemcitabine and Oxaliplatin in people with Pancreatic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The primary objective is to evaluate the efficacy of a combination of cetuximab with systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. The primary endpoint is actuarial one-year survival. 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 Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Jun 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
- Cytologic or histologic proof of adenocarcinoma of the pancreas is required prior to treatment. Patients can have tumor originating in any part of the pancreas. Islet cell tumors are not eligible. Only patients with non- metastatic, unresectable disease (AJCC 2002 stage T4 NX M0) are eligible. Computed Tomography (CT) findings of lung, liver, peritoneal metastasis are equivocal, are eligible. Patients who cannot undergo resection because of underlying medical problems are also eligible. Diagnosis of Pancreatic Adenocarcinoma by bile duce brushings are acceptable. Patients with regional nodal disease are eligible.
- All patients must be staged with a physical exam, chest X-ray (CXR), and contrast-enhanced helical thin-cut abdominal CT. Unresectability is defined by CT criteria: a) evidence of tumor extension to the celiac axis or superior mesenteric (SM) artery, or b) evidence on either CT or angiogram of occlusion of the SM vein or SM/ portal vein confluence. If a tumor does not meet this definition and is found to be unresectable at surgical exploration, then that tumor is considered unresectable.
- Patients must be 18 years and older. There will be no upper age restriction
- Karnofsky performance status greater than or equal to 70 are eligible.
- Patients must either be not of child bearing potential or have a negative urine pregnancy test within 72 hours of treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they have been postmenopausal for at least 12 months.
- Women of childbearing potential must agree to practice adequate contraception and to refrain from breast-feeding, as specified in the informed consent. Sexually active males must practice contraception during the study.
Show all 11Show fewer
- Bone marrow function: absolute neutrophil count (ANC) >1,500/ul. Platelets >100,000/ul.
- Renal function: creatinine clearance >30 mL/min (calculated with Cockcroft-Gault equation).
- Hepatic function: Total bilirubin less than 5mg/dL. If the patient required an endobiliary stent, the bilirubin level must have declined on consecutive measurements indicating adequate biliary decompression; alanine aminotransferase (ALT) less than or equal to 5 times the upper limit of normal.
- Neurologic function: neuropathy (sensory) < Common Toxicity Criteria (CTC) Grade 2.
- Patients must sign a study-specific consent form, which is attached to this protocol.
Who cannot join
- Patients with a history of prior metastatic cancer.
- Patients must not have significant infection,i.e., requiring intravenous (IV) antibiotics, or other coexistent medical condition that would preclude protocol therapy.
- Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with ejection fraction less than <30%.
- Prior therapy which specifically and directly targets the estimated EGFR pathway.
- Prior severe infusion reaction (bronchospasm, stridor, urticaria and/or hypotension) to a monoclonal antibody.
- Any prior history of radiotherapy to the abdomen.
Show all 11Show fewer
- History or evidence upon physical examination of central nervous system (CNS) disease (e.g., primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of stroke)
- Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil.
- Patients who have had an organ allograft.
- Patients on Coumadin must be changed to Lovenox at least 1 week prior to starting capecitabine. Low dose (1 mg) Coumadin is allowed.
- Patients taking Sorivudine or Brivudine A must be off of these drugs for 4 weeks prior to starting capecitabine. Patients taking cimetidine must have this drug discontinued. Ranitidine or a drug from another anti-ulcer class can be substituted for cimetidine if necessary.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Induction Cetuximab (IM-C225), Gemcitabine and Oxaliplatin, Followed by Radiotherapy With Concurrent Capecitabine, and Cetuximab, Followed by Maintenance Cetuximab and Gemcitabine for Patients With Locally Advanced Pancreatic Cancer
The primary objective is to evaluate the efficacy of a combination of cetuximab with systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. The primary endpoint is actuarial one-year survival.
The secondary objectives are:
- To evaluate the local tumor response in patients treated with the above regimen.
- To characterize the safety of the above regimen.
Read the detailed description
Cetuximab is a drug that blocks epidermal growth factor receptor (EGFR). EGFR may be involved in certain types of cancer. When EGFR is stimulated, a series of chemical reactions starts that results in a tumor being "told" to grow. Cetuximab tries to stop these reactions by blocking EGFR. This may stop tumors from growing. Cetuximab has been shown to increase the effect of chemotherapy and of radiation therapy, both of which will also be given in this study.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical exam. Blood (about 2 tablespoons) and urine will be collected for routine tests. Chest x-rays and computed tomography (CT) scans of the abdomen will be done. Women who are able to have children must have a negative urine pregnancy test.
If you are found to be eligible to take part in this study, you will first receive cetuximab every 2 weeks for 8 weeks (4 doses). Cetuximab will be given every 2 weeks throughout the duration of the study. Cetuximab will be continued during the radiation and capecitabine combination, during the retesting stage and then during the chemotherapy that is given after radiation therapy. Cetuximab infusions will be given over approximately 2 hours. Gemcitabine and oxaliplatin chemotherapy will be given once every 2 weeks (4 doses) for 8 weeks. Both drugs are given through a central line and over about 2 hours. Cetuximab will be given first, followed by gemcitabine, and then followed by oxaliplatin. A CT scan and chest X-ray will be done 2 weeks after the last dose (at Week 10).
As long as the tumor has not grown or spread, you will then receive cetuximab, capecitabine, and radiation therapy together. The Capecitabine will be given by mouth twice a day every day of radiation therapy (5 and 1/2 weeks). Radiation therapy will be given once a day for 5 days in a row. It will be given for 5 and 1/2 weeks or 28 treatments. The radiation will be given from 4 directions and focused on the tumor while you are lying on your back. You will continue to receive cetuximab by vein once every 2 weeks during capecitabine and radiation therapy.
After radiotherapy, you will continue to take cetuximab by vein every 2 weeks. The effect of treatment will be evaluated 5-6 weeks after the completion of radiation therapy and capecitabine. A chest x-ray and CT scans will be performed, and about 2 tablespoons of blood will be drawn for routine testing. As long as the tumor has not grown or spread and the side effects are not too severe, you may continue to receive Cetuximab by vein once every 2 weeks . You will also receive Gemcitabine by vein in the same dose as before for 3 out of every 4 weeks as long as the tumor does not grow and the side effects are not too severe. CT scans and chest x-rays will then be done every 2 months to evaluate the status of the tumor.
During the study, you will have physical exams, including weekly blood tests (about 2 tablespoons) each. The possible development of side effects will be closely monitored and could require extra blood and/or urine samples.
You will be taken off study if your disease gets worse or intolerable side effects occur. You may have surgery if at any time during therapy the tumor can be removed surgically. A separate consent form will be used for that situation.
This is an investigational study. Capecitabine, oxaliplatin, and cetuximab are approved by the FDA for colon cancer but have not been approved by the FDA for pancreatic cancer. Up to 69 patients will take part in this multicenter study. Up to 60 will be enrolled at M. D. Anderson.
- Conditions
- Pancreatic Cancer
- Being tested
- Cetuximab, Gemcitabine, Oxaliplatin, Capecitabine, Radiotherapy
- Keywords
- Pancreatic Cancer, Cetuximab, C225, Erbitux, Gemcitabine, Oxaliplatin, Eloxatin, Capecitabine, Xeloda
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Also called C225, Erbitux, IMC-C225
500 mg/m^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy.
GemcitabineDrug
Also called Gemzar, Gemcitabine Hydrochloride
Induction Therapy: 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses.
Chemotherapy Maintenance: 1 gm/m^2/week over 100 minutes weekly for 3 weeks then 1 week off.
OxaliplatinDrug
Also called Eloxatin
Induction Chemotherapy: 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses.
CapecitabineDrug
Also called Xeloda
Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation.
RadiotherapyRadiation
Also called XRT
Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy + Chemoradation | Experimental | Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m^2 intravenous (IV)/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions. Receives: Drug: Cetuximab; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Capecitabine; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival Rate
1-year, 2-year, and 4-year actuarial overall survival (OS) rates defined as number of participants out of total participants alive at 1, 2 or 4 years post baseline treatment.
Measured: 1 to 4 years
Median Overall Survival
Median survival is defined as the time of initiation of the first dose of chemotherapy to the date of death.
Measured: Baseline to disease progression or death, up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startSep 2005
- Primary completionJun 2011
- Study completionJun 2011
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 M.D. Anderson Cancer 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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Christopher H. Crane, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338039
- Sponsor's protocol ID
- 2004-0983
- Status last verified
- Feb 2013
- First submitted
- 27 Jan 2006
- Last updated
- 22 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction Cetuximab (IM-C225), Gemcitabine and Oxaliplatin, Followed by Radiotherapy With Concurrent Capecitabine, and Cetuximab, Followed by Maintenance Cetuximab and Gemcitabine for Patients With Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00338039
- Acronym / sponsor ID
- 2004-0983
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Cetuximab, C225, Erbitux, Gemcitabine, Oxaliplatin, Eloxatin, Capecitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Sep 2005
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 20 Jun 2006 (estimated)
- Results
- Posted 22 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to evaluate the efficacy of a combination of cetuximab with systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. The primary endpoint is actuarial one-year survival.
The secondary objectives are:
- To evaluate the local tumor response in patients treated with the above regimen.
- To characterize the safety of the above regimen.
Detailed description
Cetuximab is a drug that blocks epidermal growth factor receptor (EGFR). EGFR may be involved in certain types of cancer. When EGFR is stimulated, a series of chemical reactions starts that results in a tumor being "told" to grow. Cetuximab tries to stop these reactions by blocking EGFR. This may stop tumors from growing. Cetuximab has been shown to increase the effect of chemotherapy and of radiation therapy, both of which will also be given in this study.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical exam. Blood (about 2 tablespoons) and urine will be collected for routine tests. Chest x-rays and computed tomography (CT) scans of the abdomen will be done. Women who are able to have children must have a negative urine pregnancy test.
If you are found to be eligible to take part in this study, you will first receive cetuximab every 2 weeks for 8 weeks (4 doses). Cetuximab will be given every 2 weeks throughout the duration of the study. Cetuximab will be continued during the radiation and capecitabine combination, during the retesting stage and then during the chemotherapy that is given after radiation therapy. Cetuximab infusions will be given over approximately 2 hours. Gemcitabine and oxaliplatin chemotherapy will be given once every 2 weeks (4 doses) for 8 weeks. Both drugs are given through a central line and over about 2 hours. Cetuximab will be given first, followed by gemcitabine, and then followed by oxaliplatin. A CT scan and chest X-ray will be done 2 weeks after the last dose (at Week 10).
As long as the tumor has not grown or spread, you will then receive cetuximab, capecitabine, and radiation therapy together. The Capecitabine will be given by mouth twice a day every day of radiation therapy (5 and 1/2 weeks). Radiation therapy will be given once a day for 5 days in a row. It will be given for 5 and 1/2 weeks or 28 treatments. The radiation will be given from 4 directions and focused on the tumor while you are lying on your back. You will continue to receive cetuximab by vein once every 2 weeks during capecitabine and radiation therapy.
After radiotherapy, you will continue to take cetuximab by vein every 2 weeks. The effect of treatment will be evaluated 5-6 weeks after the completion of radiation therapy and capecitabine. A chest x-ray and CT scans will be performed, and about 2 tablespoons of blood will be drawn for routine testing. As long as the tumor has not grown or spread and the side effects are not too severe, you may continue to receive Cetuximab by vein once every 2 weeks . You will also receive Gemcitabine by vein in the same dose as before for 3 out of every 4 weeks as long as the tumor does not grow and the side effects are not too severe. CT scans and chest x-rays will then be done every 2 months to evaluate the status of the tumor.
During the study, you will have physical exams, including weekly blood tests (about 2 tablespoons) each. The possible development of side effects will be closely monitored and could require extra blood and/or urine samples.
You will be taken off study if your disease gets worse or intolerable side effects occur. You may have surgery if at any time during therapy the tumor can be removed surgically. A separate consent form will be used for that situation.
This is an investigational study. Capecitabine, oxaliplatin, and cetuximab are approved by the FDA for colon cancer but have not been approved by the FDA for pancreatic cancer. Up to 69 patients will take part in this multicenter study. Up to 60 will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy + Chemoradation | Experimental | Drug: Cetuximab, Drug: Gemcitabine, Drug: Oxaliplatin, Drug: Capecitabine, Radiation: RadiotherapySystemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m^2 intravenous (IV)/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Cytologic or histologic proof of adenocarcinoma of the pancreas is required prior to treatment. Patients can have tumor originating in any part of the pancreas. Islet cell tumors are not eligible. Only patients with non- metastatic, unresectable disease (AJCC 2002 stage T4 NX M0) are eligible. Computed Tomography (CT) findings of lung, liver, peritoneal metastasis are equivocal, are eligible. Patients who cannot undergo resection because of underlying medical problems are also eligible. Diagnosis of Pancreatic Adenocarcinoma by bile duce brushings are acceptable. Patients with regional nodal disease are eligible.
- All patients must be staged with a physical exam, chest X-ray (CXR), and contrast-enhanced helical thin-cut abdominal CT. Unresectability is defined by CT criteria: a) evidence of tumor extension to the celiac axis or superior mesenteric (SM) artery, or b) evidence on either CT or angiogram of occlusion of the SM vein or SM/ portal vein confluence. If a tumor does not meet this definition and is found to be unresectable at surgical exploration, then that tumor is considered unresectable.
- Patients must be 18 years and older. There will be no upper age restriction
- Karnofsky performance status greater than or equal to 70 are eligible.
- Patients must either be not of child bearing potential or have a negative urine pregnancy test within 72 hours of treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they have been postmenopausal for at least 12 months.
Key exclusion criteria (11 listed)
- Patients with a history of prior metastatic cancer.
- Patients must not have significant infection,i.e., requiring intravenous (IV) antibiotics, or other coexistent medical condition that would preclude protocol therapy.
- Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with ejection fraction less than <30%.
- Prior therapy which specifically and directly targets the estimated EGFR pathway.
- Prior severe infusion reaction (bronchospasm, stridor, urticaria and/or hypotension) 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 |
|---|---|---|
| CetuximabAlso: C225, Erbitux, IMC-C225500 mg/m^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. | Drug | Chemotherapy + Chemoradation |
| GemcitabineAlso: Gemzar, Gemcitabine HydrochlorideInduction Therapy: 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses. Chemotherapy Maintenance: 1 gm/m^2/week over 100 minutes weekly for 3 weeks then 1 week off. | Drug | Chemotherapy + Chemoradation |
| OxaliplatinAlso: EloxatinInduction Chemotherapy: 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. | Drug | Chemotherapy + Chemoradation |
| CapecitabineAlso: XelodaChemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation. | Drug | Chemotherapy + Chemoradation |
| RadiotherapyAlso: XRTConformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions. | Radiation | Chemotherapy + Chemoradation |
Primary outcome
Overall Survival Rate
Time frame: 1 to 4 years
1-year, 2-year, and 4-year actuarial overall survival (OS) rates defined as number of participants out of total participants alive at 1, 2 or 4 years post baseline treatment.
Median Overall Survival
Time frame: Baseline to disease progression or death, up to 4 years
Median survival is defined as the time of initiation of the first dose of chemotherapy to the date of death.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The University of Texas (UT) MD Anderson Cancer Center official websiteLink provided by the sponsor.
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
Christopher H. Crane, MD principal investigator
M.D. Anderson Cancer Center
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 Cetuximab, Gemcitabine and Oxaliplatin in people with Pancreatic Cancer, run by M.D. Anderson Cancer Center 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 11 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: finished, as of the sponsor's last update on 22 Mar 2013. 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 22 Mar 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?
Overall Survival Rate (time frame: 1 to 4 years). 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 22 Mar 2013.