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

Metastatic Colorectal Cancer Clinical Trial

Official title:

Phase II Study of Recombinant Anti-tumor and Anti-Virus Protein for Injection Plus Capatabine in Treating Patients With Metastatic Colorectal Cancer After Failure of Standard Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02068131
• Other study ID #: JH-RC-006
• Status: Recruiting
• Phase: Phase 2
• First received: February 17, 2014
• Last updated: January 4, 2016
• Start date: February 2014
• Est. completion date: December 2016

Study information

• Verified date: August 2015
• Source: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
• Contact: Xu Jianming, M.D.
• Phone: +861051128358
• Email: jmxu2003[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor and anti-virus protein for injection plus capecitabine in treating patients with metastatic colorectal cancer who have progressed after standard therapy.

Description:

This is a Phase Ⅱ exploratory clinical study. The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor and anti-virus protein for injection plus capecitabine in treating patients with metastatic colorectal cancer who have progressed after standard therapy.

All patients will receive recombinant anti-tumor and anti-virus protein for injection and capecitabine.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged above 18 years.

• Pathologically confirmed metastatic adenocarcinoma of the colon or rectum. All other histological types are excluded.

• Failure of Second-Line and more than second-line treatment, and fluoropyrimidine- and irinotecan- and oxaliplatin-containing regimens.(Subjects who progress during or within 3 months following the last administration of approved standard therapies and terminate standard treatment due to unacceptable toxicity warranting.).If recurrence and metastasis occurred within 6 months after discontinuation of adjuvant chemotherapy, the adjuvant chemotherapy is considered to be first-line treatment.Subject received last-line treatment not including capecitabine.

• 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.Malignant lymph nodes short diameter as follows: greater than or equal to 15 mm measured by spiral CT.

• ECOG performance status 0, 1 or 2.

• 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).

• Life expectancy of at least 3 months.

Exclusion Criteria:

• Prior treatment with novaferon.

• 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-a or who had interferon-a antibody.

• Patients with uncontrolled central nervous system (CNS) metastases.

Study Design

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• Novaferon
Recombinant anti-tumor and anti-virus protein for injection, 10µg, im, 3 times per week for first 2 weeks, followed by 20µg,im, 3 times per week after 2 weeks.
• Capecitabine
The dose of capecitabine is 1250 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2500 mg/m2).

Locations

Country	Name	City	State
China	307 Hospital of PLA	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate(ORR)	ORR is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments.	every 6 weeks until disease progression,assessed up to 6 months	No
Secondary	Disease control rate(DCR)	DCR is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments.	every 6 weeks until disease progression,assessed up to 6 months	No
Secondary	Progression-free survival (PFS)	PFS is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.	every 6 weeks until disease progression,assessed up to 6 months	No
Secondary	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,assessed up to 2 years	No
Secondary	Adverse Events(AEs)	AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.	from informed consent form signed to 30 days after termination of administration,assessed up to 6 months	Yes