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| Sponsors and Collaborators: |
Simcere Pharmaceutical Co., Ltd The Affiliated Changzhou Tumor Hospital of Suzhou University |
|---|---|
| Information provided by: | Simcere Pharmaceutical Co., Ltd |
| ClinicalTrials.gov Identifier: | NCT00813137 |
Purpose
FOLFOX4 plus Avastin has been suggested as firstline regimen for advanced colorectal cancer by NCCN, a new angiogenesis inhibitor, known as Endostar(Recombinant Human Endostatin), prolonged the overall survival, time to progression and improved response rate in metastatic lung cancer in a large phase III clinical trial in china, so we design this trial to evaluate the safty and efficacy of FolFox4 plus Endostar in patients with advanced colorectal cancer
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Neoplasms |
Drug: Folfox4 plus recombinant human endostatin (Endostar) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Multi-Center Study of Folfox4 Combined With Recombinant Human Endostatin(Endostar)in Advanced Colorectal Cancer |
| Estimated Enrollment: | 120 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | October 2009 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Folfox4 plus Endostar: Experimental |
Drug: Folfox4 plus recombinant human endostatin (Endostar)
Endostar 15mg iv drip D1~7, D15~21, Oxaliplatin 85mg/m2 iv drip D1,15, CF 200mg/m2 iv drip D1,2,15,16, 5-Fu 400mg/m2 iv D1,2,15,16, 5-Fu 600mg/m2 civ D1,2,15,16
|
Endostar is free supported by Shangdong Simcere Medgene biotech co.,Ltd. Endostar combination with Chemotherapy has been the first line treatment regimen to advanced NSCLC. Clinical data proved that Endostar was a wild spectrum and safe antiangiogenesis factor which could suppress almost 65 kinds of tumor mass in animal models and affect about 12 percent human genome. China NCCN colon or rectal cancer clinical practice guideline recommends Chemotherapy plus angiogenesis inhibitor as the first line treatment scheme. So we design FOLFOX4 plus Endostar to treat advanced colorectal cancer to research the RR and safety. We believe this treatment regimen may be a new approach to the advanced colorectal cancer patients.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Yang Ling, M.D. Ph.D. | medilyn2001@yahoo.com.cn |
| China, Jiangsu | |
| The Affiliated Changzhou Tumor Hospital of Suzhou University | Recruiting |
| Changzhou, Jiangsu, China, 213000 | |
| Contact: Joe, M.D. joeton@21cn.com | |
| Principal Investigator: Yang Ling, M.D, Ph.D | |
| The Affiliated Zhongda Hospital of Southeast University | Active, not recruiting |
| Nanjing, Jiangsu, China | |
| Principal Investigator: | Yang Ling, M.D, Ph.D | The Affiliated Changzhou Tumor Hospital of Suzhou University |
More Information
| Responsible Party: | the Affiliated Changzhou Tumor Hospital of Suzhou University ( Yang Ling ) |
| Study ID Numbers: | simcere0803 |
| Study First Received: | December 19, 2008 |
| Last Updated: | December 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00813137 |
| Health Authority: | China: Ministry of Health |
|
Colorectal Cancer chemotherapy recombinant human endostatin |
|
Oxaliplatin Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Fluorouracil Colonic Diseases |
Gastrointestinal Neoplasms Endostatins Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
|
Neoplasms Neoplasms by Site Antineoplastic Agents Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |
