Recombinant Anti-tumor and Anti-virus Protein for Injection in Treatment of Metastatic Colorectal Cancer

NCT01386242 | Completed Phase 2 DMC

• 1 other identifier: JH-RC-001
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor and anti-virus protein for injection in treating patients with metastatic colorectal cancer after failure of second-line and more than second-line treatment.

Conditions

Metastatic Colorectal Cancer

Keywords

Colorectal Cancer; Novaferon

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  OS is defined as the length of time from random assignment to death or to last contact.

  every 8 weeks until death, the average OS is thought to be 4.5~6 months

Secondary Outcomes (5)

• Progression-free survival (PFS)

  every 6 weeks until disease progress, the estimate averge time is 2~3 months

• Quality of life (QoL)

  every 2 weeks in first 4 weeks and every 4 weeks after 4 weeks, it will last to the treatment end.

• Adverse Events(AEs)

  from informed consent form signed to 28 days after termination of administration.

• pharmacodynamics

  The first 2 weeks during 10ug dosage were given and the following 11weeks during 20ug dosage were given

• Disease Control Rate

  every 6 weeks until disease progression

Study Arms (4)

The first group

EXPERIMENTAL

Recombinant anti-tumor and anti-virus protein for injection, twice per week

Drug: Recombinant anti-tumor and anti-virus protein for injection

The second group

EXPERIMENTAL

Recombinant anti-tumor and anti-virus protein for injection, three times per week

Drug: Recombinant anti-tumor and anti-virus protein for injection

Placebo group

PLACEBO COMPARATOR

Saline Injection, three times per week

Other: Saline Injection

The third group

EXPERIMENTAL

High dose of recombinant anti-tumor and anti-virus protein for injection, three times per week

Drug: Recombinant anti-tumor and anti-virus protein for injection

Interventions

Recombinant anti-tumor and anti-virus protein for injection DRUG

Recombinant anti-tumor and anti-virus protein for injection,10μg,im,twice per week for first 2 weeks, followed by 20μg, im, twice per week after 2 weeks

Also known as: Brand name: Novaferon

The first group

Saline Injection OTHER

Saline Injection, 1mL, im,three times per week

Placebo group

Eligibility Criteria

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

You may qualify if:

• Aged above 18 years.
• ECOG performance status 0, 1 or 2.
• Pathologically confirmed metastatic colorectal cancer.
• Failure of Second-Line or Above Treatment, and irinotecan- and oxaliplatin--containing regimens (If recurrence and metastasis occurred within 6 months after discontinuation of adjuvant chemotherapy, the adjuvant chemotherapy is considered to be first-line treatment). more than 4 weeks before enrollment after discontinuation of chemotherapy.
• Minimum of 4 weeks since any local radiotherapy or surgery for the control of symptoms or severe complications(local radiotherapy for the control of bone metastases is not the limit)，and adequately recovered from toxicities of any prior therapy).
• At least one measurable lesion according to the RECIST criteria that has not been previously local treated. Minimum indicator lesion size as follows: greater than or equal to 10 mm measured by spiral CT or NMR.
• The organ function is normal (laboratory test results came within 1 week before administration in the absence of ongoing supportive care): ANC ≥ 1.5 x 109/L, Platelets ≥ 80 x 109/L, Hgb ≥ 8.5 g/dL, serum total bilirubin ≤ 1.5 x upper limit of normal (ULN), and serum AST and ALT ≤ 2.5 x ULN(≤ 5 x ULN if liver metastases), serum creatinine ≤1.5 x ULN.
• Have been fully aware of the study and voluntarily signed the informed consent.
• Life expectancy of at least 3 months.

You may not qualify if:

• Pregnancy or breast-feeding women or women who may be pregnant were positive drug test before administration.
• Patient of child-bearing potential(male or less than 1 year postmenopausal women) were reluctant to take contraceptive measures.
• Patient who were allergic to Interferon-α or who had interferon-α antibody.
• Patients with uncontrolled central nervous system (CNS) metastases.
• Patient with any other Malignant tumors within five years (except for a complete cure of carcinoma in situ of the cervix or basal cell cancer or squamous cell skin cancer).
• Patient with Clinically uncontrolled active infection such as acute pneumonia, active hepatitis B, etc.
• Patient associated with Significant Systemic illness including, but not limited to, the following: cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, acute myocardial infarction, unstable angina, Congestive heart failure ,serious dysrhythmias, metabolic diseases, thrombosis or thromboembolic events occurred(including transient ischemic attack) in the last 6 months.
• Patient with serious autoimmune diseases in the past or at present, such as systemic lupus erythematosus, rheumatoid arthritis, thyroiditis, etc.
• Patient with ascites, pleural and pericardial effusion that cannot be controlled by drainage or symptomatic treatment.
• Investigator think Patient is not appropriate to participate in this trial for any clinical or laboratory abnormalities, or patient with any grade ≥ 2 toxicity according to NCI CTC AE 3.0 standard .
• Patient who also are accepting other systemic anti-tumor therapy (local radiotherapy for the control of bone metastases is not the limit)), in this study received 4 weeks before the start of drug treatment of other tests.
• Patient who had serious psychological or psychiatric disorder or Drug addiction or alcohol dependence.
• Patient who are estimated to be lack of compliance in this study.
• Patient with acute or subacute intestinal obstruction.

Sponsors & Collaborators

• The Affiliated Hospital of the Chinese Academy of Military Medical Sciences: lead
• Beijing Genova Biotech Company, Ltd.: collaborator

Study Sites (1)

307 Hospital of PLA

Beijing, Beijing Municipality, 100071, China

Location

Related Publications (1)

• Jia R, Wang Y, Mao XY, Li SS, Xu N, Xiong JP, Shen L, Bai L, Liu W, Liu LJ, Ge FJ, Chen YL, Lin L, Xu JM. Phase II Study of Recombinant Antitumor and Antivirus Protein Injection Compared With Placebo in Metastatic Colorectal Cancer After Failure of Standard Treatment. Oncologist. 2015 Jun;20(6):619-20. doi: 10.1634/theoncologist.2014-0439. Epub 2015 Apr 29.

  PMID: 25926350 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Injections; Sodium Chloride

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)

Drug Administration Routes; Drug Therapy; Therapeutics; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Xu jianming, M.D.

  The Affiliated Hospital of the Chinese Academy of Military Medical Scienc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: July 1, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2014
• Last Updated: January 5, 2016

Record last verified: 2015-04

Locations

CN (1)