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Sponsors and Collaborators: |
National Guard Health Affairs Sanofi-Aventis |
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Information provided by: | National Guard Health Affairs |
ClinicalTrials.gov Identifier: | NCT00636883 |
The purpose of this study is to determine if the combination of Gemcitabine, Oxaliplatin and Erlotinib in the treatment of patients with pancreatic cancer will provide increased clinical benefits and improvement in their quality of life.
Condition | Intervention | Phase |
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Pancreatic Cancer |
Drug: Gemcitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Oxaliplatin, Gemcitabine, and Erlotinib Study in Patients With Advanced Chemo-naïve Pancreatic Cancer |
Estimated Enrollment: | 34 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | January 2010 (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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have normal organ function evidenced by
Exclusion Criteria:
Contact: Nagham R Sheblaq, Bsc, pharma | 009661-2520088 ext 14689 | sheblaqn@ngha.med.sa |
Saudi Arabia | |
National Guard Health Affairs | Recruiting |
Riyadh, Saudi Arabia, 9661 | |
Contact: Marie D Gretchen, Admin 009661-2520088 ext 14171 datariom@ngha.med.sa | |
Principal Investigator: Abdul-Rahman M Jazieh, MD,MPH |
Principal Investigator: | Abdul-Rahman M Jazieh, MD,MPH | National Guard Hospital Affairs |
Responsible Party: | National Guard Health Affairs ( Dr.Abdul-Rahman Jazieh ) |
Study ID Numbers: | RC07/031 |
Study First Received: | March 8, 2008 |
Last Updated: | January 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00636883 History of Changes |
Health Authority: | Saudi Arabia: Ministry of Health; Saudi Arabia: Research Advisory Council |
Pancreatic cancer |
Erlotinib Antimetabolites Digestive System Neoplasms Immunologic Factors Pancreatic Neoplasms Endocrine System Diseases Protein Kinase Inhibitors Immunosuppressive Agents Antiviral Agents |
Oxaliplatin Digestive System Diseases Radiation-Sensitizing Agents Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Gemcitabine Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Pancreatic Neoplasms Physiological Effects of Drugs Protein Kinase Inhibitors Oxaliplatin Neoplasms by Site Therapeutic Uses Gemcitabine |
Endocrine Gland Neoplasms Erlotinib Digestive System Neoplasms Endocrine System Diseases Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Pancreatic Diseases |