Pancreatic CancerPhase 2NCT00408564
Cetuximab, Gemcitabine, and Oxaliplatin Followed By Surgery or External-Beam Radiation Therapy and Capecitabine in Treating Patients With Locally Advanced, Nonmetastatic Pancreatic Cancer That Cannot Be Removed By Surgery
A Phase 2 study testing cetuximab, capecitabine and oxaliplatin in people with Pancreatic Cancer, run by Medical University of South Carolina at 1 site in United States.
Trial summary
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. 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?
- cetuximab, capecitabine and oxaliplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Apr 2013
- 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 radiologically confirmed pancreatic cancer, meeting both of the following criteria:
- Locally advanced, nonmetastatic disease
- Surgically unresectable disease
- Measurable disease, defined as unidimensionally measurable by physical exam or imaging study
- The following are considered nonmeasurable disease:
- Bone-only disease
- Pleural or peritoneal effusions
- CNS lesions
- Irradiated lesions in the absence of progression after radiotherapy
- No history or evidence of CNS disease
- No metastatic disease to distant organs (e.g., liver, lung, brain, or bone)
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Granulocyte count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin ≤ 2.0 mg/dL
- Creatinine ≤ 2.0 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 90 days after completion of study therapy
- No acute hepatitis
- No known HIV positivity
- No active or uncontrolled infection
- No significant history of uncontrolled cardiac disease, including, but not limited to, any of the following:
- Uncontrolled hypertension
- Unstable angina
- Myocardial infarction within the past 6 months
- Uncontrolled congestive heart failure
- Cardiomyopathy with decreased ejection fraction
- No prior severe infusion reaction to a monoclonal antibody
- No active second malignancy other than nonmelanoma skin cancer
- No history of deep vein thrombosis
- No history of bleeding diathesis or coagulopathy
- No other severe concurrent disease, mental incapacitation, or psychiatric illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
- No prior therapy for pancreatic cancer
- No prior therapy specifically targeting the epidermal growth factor-receptor pathway
- No major surgical procedure or open biopsy within the past 28 days
- No prior radiotherapy or chemotherapy
- No prior or concurrent full-dose anticoagulants or thrombolytics
Trial locations and contacts
1 site in 1 country.
United States1 site
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Phase II Study of Neoadjuvant Gemcitabine/Oxaliplatin and Cetuximab Followed by Surgery or Concurrent External Beam Radiation With Capecitabine for Patients With Locally Advanced Unresectable Nonmetastatic Pancreatic Cancer
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as gemcitabine, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes when chemotherapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to chemotherapy. Giving cetuximab together with chemotherapy may reduce drug resistance and allow the tumor cells to be killed. Giving cetuximab and chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with oxaliplatin and gemcitabine followed by surgery or external-beam radiation therapy and capecitabine works in treating patients with locally advanced, nonmetastatic pancreatic cancer that cannot be removed by surgery.
Read the detailed description
OBJECTIVES:
Primary
- Determine the progression-free survival rate in patients with unresectable, locally advanced, nonmetastatic adenocarcinoma of the pancreas treated with neoadjuvant therapy comprising cetuximab, gemcitabine hydrochloride, and oxaliplatin followed by either surgery or chemoradiotherapy comprising external-beam radiotherapy and capecitabine.
Secondary
- Determine the toxicity and tolerability of this regimen in these patients.
- Determine overall survival and progression-free survival.
- Determine the response rate in these patients.
- Determine the response duration (defined as the time from first observation response to the time of progressive disease) in patients who achieve at least a partial response to treatment.
- Determine the biomarker response of CA19-9.
OUTLINE: This is an open-label study.
- Neoadjuvant therapy: Patients receive cetuximab IV over 1-2 hours on days 1 and 8, gemcitabine hydrochloride IV over 100 minutes on day 1, and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are evaluated after completion of neoadjuvant therapy. Patients with metastatic disease are taken off study. Beginning within 4 weeks after completion of neoadjuvant therapy, patients with resectable disease proceed to surgical resection or chemoradiotherapy (by choice); patients with unresectable disease proceed to chemoradiotherapy.
- Surgery: Patients undergo surgical resection with the Whipple procedure.
- Chemoradiotherapy: Patients receive oral capecitabine twice daily 5 days a week (on days 1-5) and undergo external-beam radiotherapy once daily 5 days a week for 5½ weeks.
After completion of study treatment, patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
- Conditions
- Pancreatic Cancer
- Being tested
- cetuximab, capecitabine, oxaliplatin, conventional surgery, radiation therapy
- Keywords
- adenocarcinoma of the pancreas, stage II pancreatic cancer, stage III 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.
cetuximabBiological
capecitabineDrug
oxaliplatinDrug
conventional surgeryProcedure or surgery
radiation therapyRadiation
GemcitabineDrug
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine,Oxaliplatin and Cetuximab | Experimental | Gemcitabine will be given on day 1 of every 2 week cycle. Oxaliplatin will be given day 2 of every 2 week cycle. Cetuximab will be given every week for 12 weeks.
After chemotherapy, patient will be assessed for resectability. Patients will have either surgery or daily radiation and capceitabine Monday-Friday for a total of 5 and a half weeks. Receives: Biological: cetuximab; Drug: capecitabine; Drug: oxaliplatin; Procedure: conventional surgery; Radiation: radiation therapy; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival at 6 Months
Measured: up to 46 weeks after the start of study treatment
Secondary outcomes (5)
Number of Participants With Grade 3-4 Adverse Events Reported
Measured: from start of study treatment until end of study visit, about 30 weeks
Overall Survival
Measured: up to 46 weeks after the start of study treatment
Response Rate
defined as the total number of subjects whose best response is PR or CR.
Measured: up to 46 weeks after the start of study treatment
Response Duration in Patients With at Least Partial Response to Treatment
Measured: up to 46 weeks after the start of study treatment
Determine the Biomarker Response of CA 19-9 to Therapy
Measured: from start up treatment to one year after end of treatment, up to 81 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2006 (estimated)
- Study startJan 2006
- Primary completionApr 2013
- Study completionApr 2013
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 Medical University of South CarolinaThe 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew S. Kraft, MD, Principal investigator, Medical University of South CarolinaGustavo Leone, Study chair, Medical University of South Carolina, Hollings Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408564
- Sponsor's protocol ID
- CDR0000518313
- Other IDs
- MUSC-100918, BMS-MUSC-100918, SANOFI-MUSC-100918
- Status last verified
- May 2018
- First submitted
- 6 Dec 2006
- Last updated
- 23 Jul 2018
- 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 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Neoadjuvant Gemcitabine/Oxaliplatin and Cetuximab Followed by Surgery or Concurrent External Beam Radiation With Capecitabine for Patients With Locally Advanced Unresectable Nonmetastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00408564
- Acronym / sponsor ID
- CDR0000518313
- Conditions
- Pancreatic Cancer
- Keywords
- adenocarcinoma of the pancreas, stage II pancreatic cancer, stage III pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 7 Dec 2006 (estimated)
- Results
- Posted 23 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as gemcitabine, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes when chemotherapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to chemotherapy. Giving cetuximab together with chemotherapy may reduce drug resistance and allow the tumor cells to be killed. Giving cetuximab and chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with oxaliplatin and gemcitabine followed by surgery or external-beam radiation therapy and capecitabine works in treating patients with locally advanced, nonmetastatic pancreatic cancer that cannot be removed by surgery.
Detailed description
OBJECTIVES:
Primary
- Determine the progression-free survival rate in patients with unresectable, locally advanced, nonmetastatic adenocarcinoma of the pancreas treated with neoadjuvant therapy comprising cetuximab, gemcitabine hydrochloride, and oxaliplatin followed by either surgery or chemoradiotherapy comprising external-beam radiotherapy and capecitabine.
Secondary
- Determine the toxicity and tolerability of this regimen in these patients.
- Determine overall survival and progression-free survival.
- Determine the response rate in these patients.
- Determine the response duration (defined as the time from first observation response to the time of progressive disease) in patients who achieve at least a partial response to treatment.
- Determine the biomarker response of CA19-9.
OUTLINE: This is an open-label study.
- Neoadjuvant therapy: Patients receive cetuximab IV over 1-2 hours on days 1 and 8, gemcitabine hydrochloride IV over 100 minutes on day 1, and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are evaluated after completion of neoadjuvant therapy. Patients with metastatic disease are taken off study. Beginning within 4 weeks after completion of neoadjuvant therapy, patients with resectable disease proceed to surgical resection or chemoradiotherapy (by choice); patients with unresectable disease proceed to chemoradiotherapy.
- Surgery: Patients undergo surgical resection with the Whipple procedure.
- Chemoradiotherapy: Patients receive oral capecitabine twice daily 5 days a week (on days 1-5) and undergo external-beam radiotherapy once daily 5 days a week for 5½ weeks.
After completion of study treatment, patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 42 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 |
|---|---|---|
| Gemcitabine,Oxaliplatin and Cetuximab | Experimental | Biological: cetuximab, Drug: capecitabine, Drug: oxaliplatin, Procedure: conventional surgery, Radiation: radiation therapy, Drug: GemcitabineGemcitabine will be given on day 1 of every 2 week cycle. Oxaliplatin will be given day 2 of every 2 week cycle. Cetuximab will be given every week for 12 weeks. After chemotherapy, patient will be assessed for resectability. Patients will have either surgery or daily radiation and capceitabine Monday-Friday for a total of 5 and a half weeks. |
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 |
|---|---|---|
| cetuximab | Biological | Gemcitabine,Oxaliplatin and Cetuximab |
| capecitabine | Drug | Gemcitabine,Oxaliplatin and Cetuximab |
| oxaliplatin | Drug | Gemcitabine,Oxaliplatin and Cetuximab |
| conventional surgery | Procedure or surgery | Gemcitabine,Oxaliplatin and Cetuximab |
| radiation therapy | Radiation | Gemcitabine,Oxaliplatin and Cetuximab |
| Gemcitabine | Drug | Gemcitabine,Oxaliplatin and Cetuximab |
Primary outcome
Progression-free Survival at 6 Months
Time frame: up to 46 weeks after the start of study treatment
5 secondary outcomes
Number of Participants With Grade 3-4 Adverse Events Reported
Time frame: from start of study treatment until end of study visit, about 30 weeks
Overall Survival
Time frame: up to 46 weeks after the start of study treatment
Response Rate
Time frame: up to 46 weeks after the start of study treatment
Response Duration in Patients With at Least Partial Response to Treatment
Time frame: up to 46 weeks after the start of study treatment
Determine the Biomarker Response of CA 19-9 to Therapy
Time frame: from start up treatment to one year after end of treatment, up to 81 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
- 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.
Andrew S. Kraft, MD principal investigator
Medical University of South Carolina
Gustavo Leone study chair
Medical University of South Carolina, Hollings 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, capecitabine and oxaliplatin in people with Pancreatic Cancer, run by Medical University of South Carolina 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: finished, as of the sponsor's last update on 23 Jul 2018. 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 23 Jul 2018). 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 at 6 Months (time frame: up to 46 weeks after the start of study treatment). 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 Jul 2018.