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

NCT02068131 | Unknown Phase 2

• 1 other identifier: JH-RC-006
• Study Type: interventional
• Target: 30
• 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 plus capecitabine in treating patients with metastatic colorectal cancer who have progressed after standard therapy.

Conditions

Metastatic Colorectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Disease control rate(DCR)

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

• Progression-free survival (PFS)

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

• Overall survival (OS)

  every 8 weeks until death,assessed up to 2 years

• Adverse Events(AEs)

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

Study Arms (1)

Novaferon+ xeloda

EXPERIMENTAL

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; Drug: Capecitabine

Interventions

Novaferon DRUG

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.

Novaferon+ xeloda

Capecitabine DRUG

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).

Also known as: Brand name:Xeloda

Novaferon+ xeloda

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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Hospital of the Chinese Academy of Military Medical Sciences: lead

Study Sites (1)

307 Hospital of PLA

Beijing, 100071, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

recombinant interferon alpha 2b-like protein; Capecitabine

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)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Xu Jianming, M.D.

  307 Hospital of PLA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xu Jianming, M.D.

CONTACT

+861051128358; jmxu2003@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2014
• First Posted: February 21, 2014
• Study Start: February 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 5, 2016

Record last verified: 2015-08

Locations

CN (1)