Clinical trialNACompleted
Cetuximab, Gemcitabine, and Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Pilot Study of Gemcitabine, Oxaliplatin, and Cetuximab for Locally Advanced or Metastatic Pancreatic Cancer
- Outcome
- Finished, no results posted
- Phase
- NA
- Status
- Completed
- Study type
- Interventional
- Start
- May 2006
- Expected end
- March 2011
- Enrollment
- 42 participants
- Sites
- 1
- Primary outcomes
- Progression-free survival
- Sponsor
- Other
- Results posted
- No
- Last update
- 15 December 2016
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Brief summary public domain (ClinicalTrials.gov)
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. Cetuximab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy may kill more tumor cells. PURPOSE: This clinical trial is studying how well giving cetuximab together with gemcitabine and oxaliplatin works in treating patients with locally advanced or metastatic pancreatic cancer.
Detailed description public domain (ClinicalTrials.gov)
OBJECTIVES: Primary * Determine the progression-free survival of patients with locally advanced or metastatic pancreatic cancer treated with cetuximab, gemcitabine hydrochloride, and oxaliplatin. Secondary * Determine the complete response and partial response in patients treated with this regimen. * Determine the time to progression in patients treated with this regimen. * Determine the duration of response in patients treated with this regimen. * Determine the survival of patients treated with this regimen. * Determine the toxicity of this regimen in these patients. OUTLINE: This is a nonrandomized, open-label, pilot study. 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 2-4 hours on day 2. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.