Recombinant Human Endostatin in Combination With mFOLFOX6 in Patients With Metastatic Colorectal Cancer

NCT01310478 | Unknown Phase 1

• 1 other identifier: SIM-85
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate safety and tolerance of dose-escalation of infusional recombinant human endostatin in combination with mFOLFOX6 as initial therapy for patients with metastatic colorectal cancer.

Conditions

Colorectal Neoplasm

Keywords

Recombinant human endostatin; Metastatic colorectal cancer; DLT; MTD; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Dose limiting toxicity and maximum tolerance dose of continous intravenous Endostar in combination with mFOLFOX6

  14 days

Secondary Outcomes (1)

• Parameters of human pharmacokinetics of continous intravenous Endostar in combination with mFOLFOX6

  11 days

Study Arms (1)

Endostar combined with mFOLFOX6

EXPERIMENTAL

Drug: recombinant human endostatin (Endostat)

Interventions

recombinant human endostatin (Endostat) DRUG

mFOLFOX6:Oxaliplatin 85 mg/m2 d1 Leucovorin 400 mg/m2 d1+5-FU 400 mg/m2 bolus d1+5-FU 2.4 CIV 46h Endostar 7.5mg/m2/d～45mg/m2/d continous intravenous d4～d14

Also known as: Endostar

Endostar combined with mFOLFOX6

Eligibility Criteria

• Age: 17 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of written informed consent
• Histological or cytological confirmed adenocarcinoma of the colon or rectum
• Age between 18 and 70 years.
• Patients must have received no prior systemic therapy for metastatic disease. Anyadjuvant/neoadjuvant oxaliplatin therapy must have been received \>12 months prior to study entry and adjuvant/neoadjuvant 5-FU must have been received \>6 months prior to study entry. Patients who have previously been disease free following a neoadjuvant chemotherapy regimen and resection of all primary tumour and metastatic disease are eligible..
• ECOG Performance Status of 0 or1
• Life expectancy of at least 12 weeks
• The required evidence of measurable lesions should be at least 10 mm in the longest diameter by spiral computed tomography scan or 20 mm with conventional techniques (RECIST criteria)
• Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
• Hemoglobin \> 9.0 g/dl
• Absolute neutrophil count (ANC) \>1,500/mm3
• Platelet count 100,000/μl
• Total bilirubin \< 1.5 times the upper limit of normal ALT and AST \< 2.5 x ULN(\< 5 x ULN for patients with liver involvement of their cancer)
• ALP\< 4 x ULN
• PT-INR/PTT \< 1.5 x upper limit of normal
• Serum creatinine \< 1.5 x ULN

You may not qualify if:

• History of cardiac disease:
• congestive heart failure \>NYHA class 2
• with a history of symptomatic coronary artery disease(including angina and myocardial infarction) or other ischemic heart disease
• cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension
• History of HIV infection or chronic hepatitis B or C (high copy number of HBV).
• Active clinically serious infections (\> grade 2 NCI-CTC version 3.0)
• Symptomatic metastatic brain or meningeal tumors (unless the patient is \> 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry)
• Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
• Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma within 5 years.
• Recent (\<28 days) major thoracic or abdominal surgery prior to entry into the studyor a surgical incision that is not fully healed
• Known hypersensitivity to recombinant human endostatin, oxaliplatin, 5-FU, leucovorin, capecitabine or any of the excipients of these products
• Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
• Peripheral neuropathy ≥CTC grade 2
• Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
• Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial (and men for at least 3 months after last administration of study medication).

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Endostatins; endostar protein

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors

Study Officials

• Jin Li, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiyu Chen, MD

CONTACT

+862164175590; chanhj75@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 7, 2011
• First Posted: March 8, 2011
• Study Start: August 1, 2010
• Primary Completion: May 1, 2011
• Last Updated: March 8, 2011

Record last verified: 2010-06

Locations

CN (1)