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Sponsored by: |
Fudan University |
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Information provided by: | Fudan University |
ClinicalTrials.gov Identifier: | NCT00839111 |
The purpose of this study is to evaluate the Progression-Free Survival (PFS) time of Sorafenib in combination with FOLFIRI regimen used as in the second front treatment in patients with advanced CRC after failure of oxaliplatin treatment.
Condition | Intervention | Phase |
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Colorectal Neoplasms |
Drug: sorafenib Drug: FOLFIRI |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Phase Ⅱ Open Label, Non Randomized Study, in Which Sorafenib is Used in Combination With Irinotecan, Leucovorin and Fluorouracil in Patients With Advanced Colorectal Cancer After Failure of Oxaliplatin Treatment |
Estimated Enrollment: | 43 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Sorafenib plus FOLFIRI regimen
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Drug: sorafenib
Sorafenib 400mg twice daily from d3 to d14,d17-28
Drug: FOLFIRI
Irinotecan 180 mg/m2,CF 400mg/m2 5Fu 400mg/m2 bolus, followed by 2.4g/m2 continuously intravenous infusion for 46 hours, days 1 and 15, every 4 weeks per cycle
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This is a phase Ⅱ open label, non randomized study, in which sorafenib is used in combination with irinotecan, leucovorin and fluorouracil in patients with advanced colorectal cancer after failure of oxaliplatin treatment.The aim of this study is to determine the Progression-Free Survival (PFS) of Sorafenib used in combination with FOLFIRI regimen as a second front treatment in patients with advanced CRC after failure of oxaliplatin treatment, defined as the time from treatment to disease progression or death due to any cause. The other secondary endpoints are disease control rate, defined as complete response, partial response, and stable disease.Response rate,overall survival, and safety are also evaluated.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient with metastatic disease failed after at least 2 cycles of oxaliplatin-based systemic chemotherapy, excluding adjuvant chemotherapy.
Disease progression should be proven by radiological evidence. A duration of 28 days after oxaliplatin therapy is also required.
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
Exclusion Criteria:
History of cardiac disease:
Contact: Zhiyu Chen, MD | +862164175590 ext 1107 | chanhj75@yahoo.com.cn |
China | |
Cancer Hospital,Fudan University | Recruiting |
Shanghai, China, 200032 | |
Contact: Yanfei Liu, Master +862164175590 ext 1107 |
Principal Investigator: | Jin Li, MD | Cancer Hospital,Fudan University |
Responsible Party: | Department of Medical Oncology, Cancer Hospital, Fuandan University. ( Base for drug clinical trials, Fudan University,cancer hospital. ) |
Study ID Numbers: | Bay43-9006-2008005 |
Study First Received: | February 6, 2009 |
Last Updated: | February 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00839111 History of Changes |
Health Authority: | China: State Food and Drug Administration |
Progression free survival Toxicity Response rate overall survival |
Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Irinotecan Disease Progression Leucovorin Intestinal Diseases Protein Kinase Inhibitors Rectal Diseases |
Intestinal Neoplasms Oxaliplatin Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Sorafenib Colorectal Neoplasms |
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Colonic Diseases Irinotecan Enzyme Inhibitors Intestinal Diseases Protein Kinase Inhibitors Rectal Diseases Pharmacologic Actions |
Intestinal Neoplasms Neoplasms Oxaliplatin Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Sorafenib Colorectal Neoplasms |