Oxaliplatin, Gemcitabine, and Erlotinib Study in Patients With Advanced Chemo-naïve Pancreatic Cancer
Treatment Plan GEMOX-Erlotinib consists of erlotinib 100 mg orally daily starting day 1,
Gemcitabine 1000 mg/m2 in 10 mg/m2/min (100 minutes) infusion on day 1 followed on day 2 by
oxaliplatin 100 mg/m2 in a 2-hour infusion. Treatment will be repeated every 2 weeks. Each
two weeks is a cycle. Tumor response evaluation will be performed every 2 months. If tumor
progress, patient will be off study, but if the disease is stable or PR, CR obtained will
continue treatment for total of 12 cycles. If at end of 12 cycles response continues, will
administer Gemox and erlotinib till achieve maximum response. Then start Erlotinib
maintenance therapy.
Sample size: A total of 34 patients are needed assuming expected response is greater than
10% (about 27%) and a power = 80%. Fourteen patients will be treated in the first stage; if
one patient achieved PR then additional twenty patients will be enrolled in the study for a
total of 34 patients.
Statistical Methods: Response rate with 95% CI and median time to progression of disease
will be calculated. Success will be declared if the lower limit of the 95% CI of the
response rate is greater than 10%. The 95% CI of the response rate will be calculated using
exact methods. Survival curve will be estimated using Kaplan-Meier Method. Descriptive
statistics will be used to describe patient demographics, adverse events, serious adverse
events and reasons for termination. Two approaches to the efficacy and safety analyses will
be done; the ITT (intent-to-treat) for the efficacy analysis and safety. The ITT analysis
consists of patients who received at least one dose of the study drug and at least one
on-treatment measurement of the primary efficacy endpoint (overall response). The safety
analysis consists of patients who received at least one dose of the study drug and at least
one safety measurement done. A detailed description of the statistical methods, table and
listing shells will be provided in the statistical analysis (SAP) before database lock or
data transfer to the study biostatistician.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (partial and complete response, stable disease, and progressive disease)
Tumor response will be assessed following the induction therapy and after cycle 4,8 and at the end of the treatment.
Yes
Abdul-Rahman M Jazieh, MD,MPH
Principal Investigator
National Guard Hospital Affairs
Saudi Arabia: Ministry of Health
RC07/031
NCT00636883
January 2008
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