Clinical trial NCT02068131: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: Metastatic Colorectal Cancer
Novaferon
Recombinant anti-tumor and anti-virus protein for injection
xeloda
Lead sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2014-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Overall response rate(ORR)
timeFrame: every 6 weeks until disease progression,assessed up to 6 months
Secondary outcomes:
measure: Disease control rate(DCR)
timeFrame: every 6 weeks until disease progression,assessed up to 6 months
measure: Progression-free survival (PFS)
timeFrame: every 6 weeks until disease progression,assessed up to 6 months
measure: Overall survival (OS)
timeFrame: every 8 weeks until death,assessed up to 2 years
measure: Adverse Events(AEs)
timeFrame: from informed consent form signed to 30 days after termination of administration,assessed up to 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: 307 Hospital of PLA
Study officials:
affiliation: 307 Hospital of PLA
name: Xu Jianming, M.D.
role: PRINCIPAL_INVESTIGATOR
References: