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Sponsored by: |
Sylvester Cancer Center |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00448838 |
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.
Condition | Intervention |
Pancreatic Cancer |
Drug: cetuximab Drug: gemcitabine hydrochloride Drug: oxaliplatin |
MedlinePlus related topics: | Cancer Pancreatic Cancer |
Drug Information available for: | Gemcitabine hydrochloride Gemcitabine Oxaliplatin Cetuximab |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | Pilot Study of Gemcitabine, Oxaliplatin, and Cetuximab for Locally Advanced or Metastatic Pancreatic Cancer |
Estimated Enrollment: | 40 |
Study Start Date: | May 2006 |
Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No active CNS metastases
PATIENT CHARACTERISTICS:
No significant history of uncontrolled cardiac disease, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, Florida | |||||
University of Miami Sylvester Comprehensive Cancer Center - Miami | |||||
Miami, Florida, United States, 33136 |
Sylvester Cancer Center |
Study Chair: | Caio Max S. Rocha Lima, MD | Sylvester Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000533916, SCCC-2005141, SCCC-20052717, SCCC-20057548, SANOFI-SCCC-2005141 |
First Received: | March 15, 2007 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00448838 |
Health Authority: | United States: Federal Government |
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