Efficacy and Safety Study of Recombinant Endostatin Combined With Chemotherapy to Treat Advanced Colorectal Cancer

• Status: Unknown status
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Collaborator: Simcere Pharmaceutical Co., Ltd
• Treatments: Endostar protein; Endostatins; Fluorouracil; Leucovorin; Oxaliplatin

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