Metastatic Colorectal CancerPhase 2NCT02068131
Recombinant Anti-tumor and Anti-virus Protein for Injection Plus Xeloda in Treatment of Metastatic Colorectal Cancer
A Phase 2 study testing Novaferon and Capecitabine in people with Metastatic Colorectal Cancer, run by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Novaferon and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
307 Hospital of PLA
Beijing, 100071
Xu Jianming, +861051128358, jmxu2003@yahoo.com
Xu jianming, M.D.
About this study
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
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.
Read the 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.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Novaferon, Capecitabine
- Keywords
- Metastatic Colorectal Cancer, Novaferon, Recombinant anti-tumor and anti-virus protein for injection, xeloda
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovaferonDrug
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.
CapecitabineDrug
Also called Brand name:Xeloda
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Novaferon; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: every 6 weeks until disease progression,assessed up to 6 months
Secondary outcomes (4)
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.
Measured: every 6 weeks until disease progression,assessed up to 6 months
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.
Measured: every 6 weeks until disease progression,assessed up to 6 months
Overall survival (OS)
OS is defined as the length of time from random assignment to death or to last contact.
Measured: every 8 weeks until death,assessed up to 2 years
Adverse Events(AEs)
AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
Measured: from informed consent form signed to 30 days after termination of administration,assessed up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xu Jianming, M.D., Principal investigator, 307 Hospital of PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068131
- Sponsor's protocol ID
- JH-RC-006
- Status last verified
- Aug 2015
- First submitted
- 17 Feb 2014
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02068131
- Acronym / sponsor ID
- JH-RC-006
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Metastatic Colorectal Cancer, Novaferon, Recombinant anti-tumor and anti-virus protein for injection, xeloda
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of the Chinese Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 21 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novaferon+ xeloda | Experimental | Drug: Novaferon, Drug: CapecitabineCapecitabine 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NovaferonRecombinant 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 | Novaferon+ xeloda |
| CapecitabineAlso: Brand name:XelodaThe 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). | Drug | Novaferon+ xeloda |
Primary outcome
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.
4 secondary outcomes
Disease control rate(DCR)
Time frame: 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
Overall survival (OS)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
Related trials for Metastatic Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xu Jianming, M.D. principal investigator
307 Hospital of PLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Novaferon and Capecitabine in people with Metastatic Colorectal Cancer, run by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xu Jianming, M.D. (+861051128358, jmxu2003@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate(ORR) (time frame: every 6 weeks until disease progression,assessed up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2016.