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

Primary Purpose

Metastatic Colorectal Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Novaferon

Capecitabine

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Metastatic Colorectal Cancer, Novaferon, Recombinant anti-tumor and anti-virus protein for injection, xeloda

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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-α or who had interferon-α antibody.
Patients with uncontrolled central nervous system (CNS) metastases.

Sites / Locations

307 Hospital of PLARecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Novaferon+ xeloda

Arm Description

Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21). Recombinant anti-tumor and anti-virus protein for injection(Novaferon), three times per week.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Overall survival (OS)

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

Adverse Events(AEs)

AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.

Full Information

NCT ID

NCT02068131

First Posted

February 17, 2014

Last Updated

January 4, 2016

Sponsor

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02068131

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Unknown status

Study Start Date

February 2014 (undefined)

Primary Completion Date

November 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Colorectal Cancer

Keywords

Metastatic Colorectal Cancer, Novaferon, Recombinant anti-tumor and anti-virus protein for injection, xeloda

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Novaferon+ xeloda

Arm Type

Experimental

Arm Description

Capecitabine for 2 weeks straight (Days 1-14) followed by 1 week without capecitabine (Days 15-21). Recombinant anti-tumor and anti-virus protein for injection(Novaferon), three times per week.

Intervention Type

Drug

Intervention Name(s)

Novaferon

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Other Intervention Name(s)

Brand name:Xeloda

Intervention Description

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).

Primary Outcome Measure Information:

Title

Overall response rate(ORR)

Description

ORR is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments.

Time Frame

every 6 weeks until disease progression,assessed up to 6 months

Secondary Outcome Measure Information:

Title

Disease control rate(DCR)

Description

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.

Time Frame

every 6 weeks until disease progression,assessed up to 6 months

Title

Progression-free survival (PFS)

Description

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.

Time Frame

every 6 weeks until disease progression,assessed up to 6 months

Title

Overall survival (OS)

Description

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

Time Frame

every 8 weeks until death,assessed up to 2 years

Title

Adverse Events(AEs)

Description

AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.

Time Frame

from informed consent form signed to 30 days after termination of administration,assessed up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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-α or who had interferon-α antibody. Patients with uncontrolled central nervous system (CNS) metastases.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xu Jianming, M.D.

Phone

+861051128358

jmxu2003@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xu Jianming, M.D.

Organizational Affiliation

307 Hospital of PLA

Official's Role

Principal Investigator

Facility Information:

Facility Name

307 Hospital of PLA

City

Beijing

ZIP/Postal Code

100071

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xu Jianming

Phone

+861051128358

jmxu2003@yahoo.com

First Name & Middle Initial & Last Name & Degree

Xu jianming, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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