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2006-01
2013-04
2013-04
39
NCT00408564
Medical University of South Carolina
Medical University of South Carolina
INTERVENTIONAL
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
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2006-12-06 | 2018-05-23 | 2018-07-19 |
2006-12-06 | 2018-07-19 | 2018-07-23 |
2006-12-07 | 2018-07-23 | 2018-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Gemcitabine,Oxaliplatin and Cetuximab 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 su | BIOLOGICAL: cetuximab DRUG: capecitabine DRUG: oxaliplatin PROCEDURE: conventional surgery RADIATION: radiation therapy DRUG: Gemcitabine |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Progression-free Survival at 6 Months | up to 46 weeks after the start of study treatment |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of Participants With Grade 3-4 Adverse Events Reported | from start of study treatment until end of study visit, about 30 weeks | |
| Overall Survival | 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. | up to 46 weeks after the start of study treatment |
| Response Duration in Patients With at Least Partial Response to Treatment | up to 46 weeks after the start of study treatment | |
| Determine the Biomarker Response of CA 19-9 to Therapy | from start up treatment to one year after end of treatment, up to 81 weeks |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
