Oxaliplatin, Gemcitabine, and Erlotinib Study in Patients With Advanced Chemo-naïve Pancreatic Cancer (GEMOX-T)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Oxaliplatin, Gemcitabine, and Erlotinib Study in Patients With Advanced Chemo-naïve Pancreatic Cancer|
- Response rate (partial and complete response, stable disease, and progressive disease) [ Time Frame: Tumor response will be assessed following the induction therapy and after cycle 4,8 and at the end of the treatment. ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: UNMEASURABLE ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2008|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636883
|National Guard Health Affairs|
|Riyadh, Saudi Arabia, 9661|
|Principal Investigator:||Abdul-Rahman M Jazieh, MD,MPH||National Guard Hospital Affairs|