Efficacy and Safety Study of Recombinant Endostatin Combined With Chemotherapy to Treat Advanced Colorectal Cancer
This study is currently recruiting participants.
Verified February 2012 by Chinese Academy of Medical Sciences
Sponsor:
Chinese Academy of Medical Sciences
Collaborator:
Simcere Pharmaceutical Co., Ltd
Information provided by (Responsible Party):
Lin Yang, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01529164
First received: February 4, 2012
Last updated: February 7, 2012
Last verified: February 2012
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Purpose
Studies suggest that the addition of antiangiogenic agents to conventional therapeutic strategies, e.g., chemotherapy, radiation, or other tumor-targeting agents, will increase clinical efficacy. For advanced colorectal cancer,the antiangiogenic agent bevacizumab has become an important treatment option and its combination with chemotherapy is now being one of the standard first line therapy. This phase II study was conducted to determine the efficacy and safety of another antiangiogenesis inhibitor rh-endostatin plus mFOLFOX6 in advanced colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: Endostatins (Endostar) Drug: Oxaliplatin Drug: Leucovorin Drug: 5-fluorouracil |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Recombinant Endostatin Combined With Modified FOLFOX6 in Advanced Colorectal Cancer |
Resource links provided by NLM:
Further study details as provided by Chinese Academy of Medical Sciences:
Primary Outcome Measures:
- response rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]From date of treatment was administered until the date of first documented response according to RECIST criteria
Secondary Outcome Measures:
- progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]From date of chemotherapy was administered until the date of first documented progression or date of death from any cause, whichever came first, assessed every 8 weeks.
- overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]From date of treatment was administered until the date of death from any cause, assessed every 3 months.
- Number of participants with adverse events [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]assessed from the date of treatment to 1 month after stop treatment
| Estimated Enrollment: | 51 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: treatment |
Drug: Endostatins (Endostar)
7.5mg/m2 iv d1-10,repeat every 14 days,until progression or occurrence of untolerated toxicity
Other Name: Endostar
Drug: Oxaliplatin
85mg/m2 iv d1 ,repeat every 14 days,until progression or occurrence of untolerated toxicity
Other Name: Eloxatin
Drug: Leucovorin
200mg/m2 iv d1 ,repeat every 14 days
Drug: 5-fluorouracil
400mg/m2 iv bolus,then 2400mg/m2 continuous infusion for 46 hours,repeated every 14 days,until progression or occurrence of untolerated toxicity
|
Detailed Description:
Rh-Endostatin (Endostar; Simcere Pharmaceutical Co., Ltd, JiangSu,China) is a humanized recombinant endostatin which is a direct angiogenesis inhibitor targeting the microvascular endothelial cells (ECs). A pivotal phase III study completed in China demonstrated that the addition of rh-endostatin to navelbine plus cisplatin conferred clinically significant improvements in overall survival (OS), progression-free survival (PFS), as well as response rate (RR), in patients with previously untreated metastatic non small cell lung cancer (NSCLC). In vitro, the combination of Endostatin and fluorouracil showed synergistic activity in inhibiting colon cancer. MFolfox6 was standard first-line regimen in advanced colorectal cancer. The investigators carried out a phase II trial to investigate the activity and safety of rh-endostatin plus mFOLFOX in patients with metastatic colorectal cancer.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Signed informed consent (IC)
- Age greater than or equal to 18 years
- Histologically or cytologically confirmed metastatic or recurrent colorectal tumors with no previous treatment for advanced disease.
- At least one measurable lesion according to the RECIST criteria which has not been irradiated (i.e. newly arising lesions in previously irradiated areas are accepted). Minimum indicator lesion size: > 10 mm measured by spiral CT or >20mm measured by conventional techniques
- ECOG performance status 0-1
- Life expectancy > 3 months
- ECG is normal
Exclusion Criteria:
- Pregnant or lactating woman
- Any prior oxaliplatin treatment, with the exception of adjuvant therapy given > 12 months prior to the beginning of study therapy,and any prior 5－fluorouracil treatment, with the exception of adjuvant therapy given > 6 months prior to the beginning of study therapy
- Any prior endostatin treatment
- known hypersensitivity to 5-fluorouracil,oxaliplatin,leucovorin
- History of persistent neurosensory disorder including but not limited to peripheral neuropathy
- known DPD deficiency
- Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer
- Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) within the last 6 months
Any of the following laboratory values:
- Abnormal hematologic values (neutrophils < 1.5 x 109/L, platelet count < 100 x 109/L)
- Urine protein: creatinine ratio >/= 1.0, Impaired renal function with estimated creatinine clearance < 30 ml/min
- Serum bilirubin > 1.5 x upper normal limit. ALT, AST > 2.5 x upper normal limit (or > 5 x upper normal limit in the case of liver metastases)
- Alkaline phosphatase > 2.5 x upper normal limit (or > 5 x upper normal limit in the case of liver metastases or > 10 x upper normal limit in the case of bone disease)
- use of full-dose anticoagulants or thrombolytics
- known CNS metastases
- serious nonhealing wound, ulcer, or bone fracture
- clinically significant bleeding diathesis or coagulopathy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529164
Contacts
| Contact: Wen Zhang, MD | 86-10-87788145 | wenwen0605@163.com |
| Contact: Lin Yang, MD | 86-10-87788118 | lyang69@sina.com.cn |
Locations
| China, Beijing | |
| Cancer hospital & Institute,Chinese Academy of Medical Sciences | Recruiting |
| Beijing, Beijing, China, 100021 | |
| Contact: Wen Zhang, MD 86-10-87788145 wenwen0605@163.com | |
| Contact: Lin Yang, MD 86-10-87788118 lyang69@sina.com.cn | |
| Principal Investigator: Lin Yang, MD | |
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Simcere Pharmaceutical Co., Ltd
Investigators
| Principal Investigator: | Lin Yang, MD | Cancer hospital&institute,Chinese Academy of Medical Sciences |
More Information
No publications provided
| Responsible Party: | Lin Yang, associated professor, Chinese Academy of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01529164 History of Changes |
| Other Study ID Numbers: | CH-GI-023 |
| Study First Received: | February 4, 2012 |
| Last Updated: | February 7, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Chinese Academy of Medical Sciences:
|
endostatin chemotherapy antiangiogenesis agent colorectal cancer |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Fluorouracil Oxaliplatin Endostatins Leucovorin |
Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes |
ClinicalTrials.gov processed this record on May 23, 2013