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Trial record 93 of 435 for:    colon cancer AND Capecitabine AND colon cancer

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

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ClinicalTrials.gov Identifier: NCT02068131
Recruitment Status : Unknown
Verified August 2015 by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences.
Recruitment status was:  Recruiting
First Posted : February 21, 2014
Last Update Posted : January 5, 2016
Sponsor:
Information provided by (Responsible Party):
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Novaferon Drug: Capecitabine Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2014
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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 Name: Brand name:Xeloda




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068131


Contacts
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Contact: Xu Jianming, M.D. +861051128358 jmxu2003@yahoo.com

Locations
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China
307 Hospital of PLA Recruiting
Beijing, China, 100071
Contact: Xu Jianming    +861051128358    jmxu2003@yahoo.com   
Principal Investigator: Xu jianming, M.D.         
Sponsors and Collaborators
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Investigators
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Principal Investigator: Xu Jianming, M.D. 307 Hospital of PLA

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Responsible Party: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT02068131     History of Changes
Other Study ID Numbers: JH-RC-006
First Posted: February 21, 2014    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: August 2015
Keywords provided by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences:
Metastatic Colorectal Cancer
Novaferon
Recombinant anti-tumor and anti-virus protein for injection
xeloda
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Capecitabine
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Interferons
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents