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

January 4, 2016 updated by: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100071
        • Recruiting
        • 307 Hospital of PLA
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Novaferon+ xeloda

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.
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.
Drug: 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).
Other Names:
  • Brand name:Xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate(ORR)
Time Frame: every 6 weeks until disease progression,assessed up to 6 months
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate(DCR)
Time Frame: every 6 weeks until disease progression,assessed up to 6 months
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
Progression-free survival (PFS)
Time Frame: every 6 weeks until disease progression,assessed up to 6 months
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
Overall survival (OS)
Time Frame: every 8 weeks until death,assessed up to 2 years
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
Adverse Events(AEs)
Time Frame: from informed consent form signed to 30 days after termination of administration,assessed up to 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

February 17, 2014

First Submitted That Met QC Criteria

February 20, 2014

First Posted (Estimate)

February 21, 2014

Study Record Updates

Last Update Posted (Estimate)

January 5, 2016

Last Update Submitted That Met QC Criteria

January 4, 2016

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JH-RC-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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