Cetuximab, Gemcitabine, and Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00448838|
Recruitment Status : Completed
First Posted : March 19, 2007
Last Update Posted : December 15, 2016
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 or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Biological: Cetuximab Drug: Gemcitabine Hydrochloride Drug: Oxaliplatin||Not Applicable|
- Determine the progression-free survival of patients with locally advanced or metastatic pancreatic cancer treated with cetuximab, gemcitabine hydrochloride, and oxaliplatin.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Gemcitabine, Oxaliplatin, and Cetuximab for Locally Advanced or Metastatic Pancreatic Cancer|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||August 2007|
|Actual Study Completion Date :||March 2011|
- Biological: Cetuximab
Cetuximab: an initial loading dose of 400 mg/m2 will be given followed by 250 mg/m2 administered weekly. Cetuximab will be given first followed by gemcitabine on the weeks the patient receives cytotoxic chemotherapy on day 1. Cetuximab will be given as a single agent on Day 8. The treatment will be given on two-week cycles.Other Name: C-225
- Drug: Gemcitabine Hydrochloride
Gemcitabine 1000 mg/m2 IV day 1. The treatment will be given on two-week cycles.Other Name: Gemcitabine HCl
- Drug: Oxaliplatin
Oxaliplatin 100 mg/m2 IV day 2. The treatment will be given on two-week cycles.
- Progression-free survival [ Time Frame: The cumulative percentage of intent to treat patients who experience disease progression at 1, 2, 3, 4, 5, and 6 months will be characterized with corresponding 95% confidence intervals ]The corresponding progression-free survival curve and cumulative risk of progression as a function of time post treatment initiation will be estimated using the Kaplan-Meier method
- Toxicity [ Time Frame: Frequency and severity of adverse events according to the NCI CTCAE V 3.0 body system and severity criteria will be described. ]
- Response rate (complete response and partial response) [ Time Frame: After every 4th cycle; End of Treatment and Follow-up ]The response rate will be determined by the RECIST criteria. After every 4th cycle; End of Treatment and Follow-up
- Duration of response [ Time Frame: The time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented ]the time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented, taking as reference for PD the smallest measurements recorded since the treatment started
- Overall survival [ Time Frame: Overall survival will also be estimated using the product-limit method of Kaplan-Meier. ]Overall survival will also be estimated using the product-limit method of Kaplan-Meier.
- Time to progression [ Time Frame: The time from the start of the treatment until the criteria for disease progression are met ]The time from the start of the treatment until the criteria for disease progression are met, taking as reference the smallest measurements recorded since the treatment started (also referred to in the RECIST criteria as duration of stable disease).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00448838
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center - Miami|
|Miami, Florida, United States, 33136|
|Study Chair:||Caio Max S. Rocha Lima, MD||University of Miami Sylvester Comprehensive Cancer Center|