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Phase II Study of Recombinant Endostatin Combined With Modified FOLFOX6 in Advanced Colorectal Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

Phase II Study of Recombinant Endostatin Combined With Modified FOLFOX6 in Advanced Colorectal Cancer


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response rate

Outcome Description:

From date of treatment was administered until the date of first documented response according to RECIST criteria

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Lin Yang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer hospital&institute,Chinese Academy of Medical Sciences

Authority:

China: Food and Drug Administration

Study ID:

CH-GI-023

NCT ID:

NCT01529164

Start Date:

October 2011

Completion Date:

March 2014

Related Keywords:

  • Colorectal Cancer
  • endostatin
  • chemotherapy
  • antiangiogenesis agent
  • colorectal cancer
  • Colorectal Neoplasms

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