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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01310478
First received: March 7, 2011
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Colorectal Neoplasm
Drug: recombinant human endostatin (Endostat)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PhaseⅠClinical Study of Recombinant Human Endostatin in Combination With mFOLFOX6 as Initial Therapy for Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Dose limiting toxicity and maximum tolerance dose of continous intravenous Endostar in combination with mFOLFOX6 [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Parameters of human pharmacokinetics of continous intravenous Endostar in combination with mFOLFOX6 [ Time Frame: 11 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: August 2010
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endostar combined with mFOLFOX6 Drug: recombinant human endostatin (Endostat)
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
Other Name: Endostar

Detailed Description:

Recombinant human endostatin(Endostar) is commonly used through intermittent intravenous adminstration in routine clinical practice in China. It is very difficult to maintain steady-state of plasma concentration of this agent due to this manner of application. Continous infusional Endostar was designed to alter the imblance of concentration to avoid compromising efficacy of anti-angionesis therapy.The strategy of dose-escalation was used in this study in order to obtain the optimal dosage of Endostar for the next phase Ⅱ trial.

  Eligibility

Ages Eligible for Study:   17 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of written informed consent
  2. Histological or cytological confirmed adenocarcinoma of the colon or rectum
  3. Age between 18 and 70 years.
  4. 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..
  5. ECOG Performance Status of 0 or1
  6. Life expectancy of at least 12 weeks
  7. 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)
  8. 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

Exclusion Criteria:

  1. 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
  2. History of HIV infection or chronic hepatitis B or C (high copy number of HBV).
  3. Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
  4. 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)
  5. Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
  6. 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.
  7. Recent (<28 days) major thoracic or abdominal surgery prior to entry into the studyor a surgical incision that is not fully healed
  8. Known hypersensitivity to recombinant human endostatin, oxaliplatin, 5-FU, leucovorin, capecitabine or any of the excipients of these products
  9. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
  10. Peripheral neuropathy ≥CTC grade 2
  11. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
  12. 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01310478

Contacts
Contact: Zhiyu Chen, MD +862164175590 chanhj75@yahoo.com.cn

Locations
China, Shanghai
Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China
Contact: Zhiyu Chen, MD         
Principal Investigator: Jin Li, MD         
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Jin Li, MD Shanghai Cancer Center,Fudan University
  More Information

No publications provided

Responsible Party: Base for drug clinical trials,Shanghai Cancer Center, Fudan University, Department of medical oncology, Shanghai Cancer Center,Fuandan University
ClinicalTrials.gov Identifier: NCT01310478     History of Changes
Other Study ID Numbers: SIM-85
Study First Received: March 7, 2011
Last Updated: March 7, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Fudan University:
Recombinant human endostatin
Metastatic colorectal cancer
DLT
MTD
Pharmacokinetics

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
Endostatins
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014