Colorectal NeoplasmsPhase 2NCT00813137
FOLFOX4 Combined With Endostar in Patients With Advanced Colorectal Cancer
A Phase 2 study testing Folfox4 plus recombinant human endostatin (Endostar) in people with Colorectal Neoplasms, run by Simcere Pharmaceutical Co., Ltd at 2 sites in China.
Trial summary
FOLFOX4 plus Avastin has been suggested as firstline regimen for advanced colorectal cancer by NCCN, a new angiogenesis inhibitor, known as Endostar(Recombinant Human Endostatin), prolonged the overall survival, time to progression and improved response rate in metastatic lung cancer in a large phase III clinical… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Folfox4 plus recombinant human endostatin (Endostar)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- Oct 2008to Oct 2010
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically or cytologically confirmed metastatic CRC
- Measurable disease according to Response Criteria In Solid Tumours (RECIST)
- Performance Status 0 - 2 according to ECOG (Eastern Cooperative Oncology Group) Performance Status
- Age 18~75
- Life expectancy > 3 months
- Signed informed consent (IC)
- Adequate haematological and biological functions
Who cannot join
- Pregnant or lactating women
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drugs
- Neuropathy, brain, or leptomeningeal involvement
- Treatment with any biologic, cytotoxic, radiation , or hormonal therapy within four weeks.
- Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia
- Uncontrolled significant comorbid conditions and previous radiotherapy
Trial locations and contacts
2 sites in 1 country.
Yang Ling, M.D. Ph.D. contact
China2 sites, 1 recruiting
- Recruiting
The Affiliated Changzhou Tumor Hospital of Suzhou University
Changzhou, Jiangsu, 213000
Joe, M.D., joeton@21cn.com
Yang Ling, M.D, Ph.D
- Active, not recruiting
The Affiliated Zhongda Hospital of Southeast University
Nanjing, Jiangsu
About this study
Official title: A Multi-center Study of Folfox4 Combined With Recombinant Human Endostatin(Endostar)in Advanced Colorectal Cancer
FOLFOX4 plus Avastin has been suggested as firstline regimen for advanced colorectal cancer by NCCN, a new angiogenesis inhibitor, known as Endostar(Recombinant Human Endostatin), prolonged the overall survival, time to progression and improved response rate in metastatic lung cancer in a large phase III clinical trial in china, so we design this trial to evaluate the safty and efficacy of FolFox4 plus Endostar in patients with advanced colorectal cancer
Read the detailed description
Endostar is free supported by Shangdong Simcere Medgene biotech co.,Ltd. Endostar combination with Chemotherapy has been the first line treatment regimen to advanced NSCLC. Clinical data proved that Endostar was a wild spectrum and safe antiangiogenesis factor which could suppress almost 65 kinds of tumor mass in animal models and affect about 12 percent human genome. China NCCN colon or rectal cancer clinical practice guideline recommends Chemotherapy plus angiogenesis inhibitor as the first line treatment scheme. So we design FOLFOX4 plus Endostar to treat advanced colorectal cancer to research the RR and safety. We believe this treatment regimen may be a new approach to the advanced colorectal cancer patients.
- Conditions
- Colorectal Neoplasms
- Being tested
- Folfox4 plus recombinant human endostatin (Endostar)
- Keywords
- Colorectal Cancer, chemotherapy, recombinant human endostatin
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folfox4 plus recombinant human endostatin (Endostar)Drug
Also called endostar, Folfox4, L-OHP, CF
Endostar 15mg iv drip D1~7, D15~21, Oxaliplatin 85mg/m2 iv drip D1,15, CF 200mg/m2 iv drip D1,2,15,16, 5-Fu 400mg/m2 iv D1,2,15,16, 5-Fu 600mg/m2 civ D1,2,15,16
| Study group | Role | What they receive |
|---|---|---|
| Folfox4 plus Endostar | Experimental | Not described Receives: Drug: Folfox4 plus recombinant human endostatin (Endostar) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression
Measured: every two cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2010 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Simcere Pharmaceutical Co., Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Changzhou Tumor Hospital of Suzhou University
- Investigators
- Yang Ling, M.D, Ph.D, Principal investigator, The Affiliated Changzhou Tumor Hospital of Suzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813137
- Sponsor's protocol ID
- simcere0803
- Status last verified
- Dec 2009
- First submitted
- 19 Dec 2008
- Last updated
- 8 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Study of Folfox4 Combined With Recombinant Human Endostatin(Endostar)in Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00813137
- Acronym / sponsor ID
- simcere0803
- Conditions
- Colorectal Neoplasms
- Keywords
- Colorectal Cancer, chemotherapy, recombinant human endostatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Simcere Pharmaceutical Co., LtdUniversity, hospital or other
- Collaborators
- The Affiliated Changzhou Tumor Hospital of Suzhou University
- Study start
- Oct 2008
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 22 Dec 2008 (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.
FOLFOX4 plus Avastin has been suggested as firstline regimen for advanced colorectal cancer by NCCN, a new angiogenesis inhibitor, known as Endostar(Recombinant Human Endostatin), prolonged the overall survival, time to progression and improved response rate in metastatic lung cancer in a large phase III clinical trial in china, so we design this trial to evaluate the safty and efficacy of FolFox4 plus Endostar in patients with advanced colorectal cancer
Detailed description
Endostar is free supported by Shangdong Simcere Medgene biotech co.,Ltd. Endostar combination with Chemotherapy has been the first line treatment regimen to advanced NSCLC. Clinical data proved that Endostar was a wild spectrum and safe antiangiogenesis factor which could suppress almost 65 kinds of tumor mass in animal models and affect about 12 percent human genome. China NCCN colon or rectal cancer clinical practice guideline recommends Chemotherapy plus angiogenesis inhibitor as the first line treatment scheme. So we design FOLFOX4 plus Endostar to treat advanced colorectal cancer to research the RR and safety. We believe this treatment regimen may be a new approach to the advanced colorectal cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Folfox4 plus Endostar | Experimental | Drug: Folfox4 plus recombinant human endostatin (Endostar) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with histologically or cytologically confirmed metastatic CRC
- Measurable disease according to Response Criteria In Solid Tumours (RECIST)
- Performance Status 0 - 2 according to ECOG (Eastern Cooperative Oncology Group) Performance Status
- Age 18~75
- Life expectancy > 3 months
Key exclusion criteria (6 listed)
- Pregnant or lactating women
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study drugs
- Neuropathy, brain, or leptomeningeal involvement
- Treatment with any biologic, cytotoxic, radiation , or hormonal therapy within four weeks.
- Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia
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 |
|---|---|---|
| Folfox4 plus recombinant human endostatin (Endostar)Also: endostar, Folfox4, L-OHP, CFEndostar 15mg iv drip D1~7, D15~21, Oxaliplatin 85mg/m2 iv drip D1,15, CF 200mg/m2 iv drip D1,2,15,16, 5-Fu 400mg/m2 iv D1,2,15,16, 5-Fu 600mg/m2 civ D1,2,15,16 | Drug | Folfox4 plus Endostar |
Primary outcome
Time to progression
Time frame: every two cycles
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2009.
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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.
Yang Ling, M.D. Ph.D. contact
Yang Ling, M.D, Ph.D principal investigator
The Affiliated Changzhou Tumor Hospital of Suzhou University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Folfox4 plus recombinant human endostatin (Endostar) in people with Colorectal Neoplasms, run by Simcere Pharmaceutical Co., Ltd at 2 sites 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 6 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 8 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Yang Ling, M.D. Ph.D. (medilyn2001@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to progression (time frame: every two cycles). 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 8 Dec 2009.