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.
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Progression-free survival at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Overall survival and progression-free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Response duration in patients with at least partial response to treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- survial behaviors [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2006|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
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.
|Biological: cetuximab Drug: oxaliplatin Drug: Gemcitabine|
Experimental: Radiation and capecitabine
Daily radiation and capceitabine Monday-Friday for a total of 5 and a half weeks.
|Drug: capecitabine Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00408564
|United States, South Carolina|
|Hollings Cancer Center at Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Andrew S. Kraft, MD||Medical University of South Carolina|