Colorectal CancerPhase 2NCT01529164
Efficacy and Safety Study of Recombinant Endostatin Combined With Chemotherapy to Treat Advanced Colorectal Cancer
A Phase 2 study testing Endostatins (Endostar), Oxaliplatin and Leucovorin in people with Colorectal Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Studies suggest that the addition of antiangiogenic agents to conventional therapeutic strategies, e.g., chemotherapy, radiation, or other tumor-targeting agents, will increase clinical efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Endostatins (Endostar), Oxaliplatin and Leucovorin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- Oct 2011to Sep 2014
- 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
- Signed informed consent (IC)
- Age greater than or equal to 18 years
- Histologically or cytologically confirmed metastatic or recurrent colorectal tumors with no previous treatment for advanced disease.
- At least one measurable lesion according to the RECIST criteria which has not been irradiated (i.e. newly arising lesions in previously irradiated areas are accepted). Minimum indicator lesion size: > 10 mm measured by spiral CT or >20mm measured by conventional techniques
- ECOG performance status 0-1
- Life expectancy > 3 months
- ECG is normal
Who cannot join
- Pregnant or lactating woman
- Any prior oxaliplatin treatment, with the exception of adjuvant therapy given > 12 months prior to the beginning of study therapy,and any prior 5-fluorouracil treatment, with the exception of adjuvant therapy given > 6 months prior to the beginning of study therapy
- Any prior endostatin treatment
- known hypersensitivity to 5-fluorouracil,oxaliplatin,leucovorin
- History of persistent neurosensory disorder including but not limited to peripheral neuropathy
- known DPD deficiency
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- Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer
- Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) within the last 6 months
- Any of the following laboratory values:
- Abnormal hematologic values (neutrophils < 1.5 x 109/L, platelet count < 100 x 109/L)
- Urine protein: creatinine ratio >/= 1.0, Impaired renal function with estimated creatinine clearance < 30 ml/min
- Serum bilirubin > 1.5 x upper normal limit. ALT, AST > 2.5 x upper normal limit (or > 5 x upper normal limit in the case of liver metastases)
- Alkaline phosphatase > 2.5 x upper normal limit (or > 5 x upper normal limit in the case of liver metastases or > 10 x upper normal limit in the case of bone disease)
- use of full-dose anticoagulants or thrombolytics
- known CNS metastases
- serious nonhealing wound, ulcer, or bone fracture
- clinically significant bleeding diathesis or coagulopathy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer hospital & Institute,Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Wen Zhang, MD, 86-10-87788145, wenwen0605@163.com
Lin Yang, MD, 86-10-87788118, lyang69@sina.com.cn
About this study
Official title: Phase II Study of Recombinant Endostatin Combined With Modified FOLFOX6 in Advanced Colorectal Cancer
Studies suggest that the addition of antiangiogenic agents to conventional therapeutic strategies, e.g., chemotherapy, radiation, or other tumor-targeting agents, will increase clinical efficacy. For advanced colorectal cancer,the antiangiogenic agent bevacizumab has become an important treatment option and its combination with chemotherapy is now being one of the standard first line therapy. This phase II study was conducted to determine the efficacy and safety of another antiangiogenesis inhibitor rh-endostatin plus mFOLFOX6 in advanced colorectal cancer.
Read the detailed description
Rh-Endostatin (Endostar; Simcere Pharmaceutical Co., Ltd, JiangSu,China) is a humanized recombinant endostatin which is a direct angiogenesis inhibitor targeting the microvascular endothelial cells (ECs). A pivotal phase III study completed in China demonstrated that the addition of rh-endostatin to navelbine plus cisplatin conferred clinically significant improvements in overall survival (OS), progression-free survival (PFS), as well as response rate (RR), in patients with previously untreated metastatic non small cell lung cancer (NSCLC). In vitro, the combination of Endostatin and fluorouracil showed synergistic activity in inhibiting colon cancer. MFolfox6 was standard first-line regimen in advanced colorectal cancer. The investigators carried out a phase II trial to investigate the activity and safety of rh-endostatin plus mFOLFOX in patients with metastatic colorectal cancer.
- Conditions
- Colorectal Cancer
- Being tested
- Endostatins (Endostar), Oxaliplatin, Leucovorin, 5-fluorouracil
- Keywords
- endostatin, chemotherapy, antiangiogenesis agent, colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endostatins (Endostar)Drug
Also called Endostar
7.5mg/m2 iv d1-10,repeat every 14 days,until progression or occurrence of untolerated toxicity
OxaliplatinDrug
Also called Eloxatin
85mg/m2 iv d1 ,repeat every 14 days,until progression or occurrence of untolerated toxicity
LeucovorinDrug
200mg/m2 iv d1 ,repeat every 14 days
5-fluorouracilDrug
400mg/m2 iv bolus,then 2400mg/m2 continuous infusion for 46 hours,repeated every 14 days,until progression or occurrence of untolerated toxicity
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Not described Receives: Drug: Endostatins (Endostar); Drug: Oxaliplatin; Drug: Leucovorin; Drug: 5-fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
From date of treatment was administered until the date of first documented response according to RECIST criteria
Measured: 3 years
Secondary outcomes (3)
progression free survival
From date of chemotherapy was administered until the date of first documented progression or date of death from any cause, whichever came first, assessed every 8 weeks.
Measured: 3 years
overall survival
From date of treatment was administered until the date of death from any cause, assessed every 3 months.
Measured: 3 years
Number of participants with adverse events
assessed from the date of treatment to 1 month after stop treatment
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startOct 2011
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Simcere Pharmaceutical Co., Ltd
- Responsible party
- Principal investigator, Lin Yang, Chinese Academy of Medical Sciences
- Investigators
- Lin Yang, MD, Principal investigator, Cancer hospital&institute,Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529164
- Sponsor's protocol ID
- CH-GI-023
- Status last verified
- Nov 2013
- First submitted
- 4 Feb 2012
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Recombinant Endostatin Combined With Modified FOLFOX6 in Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01529164
- Acronym / sponsor ID
- CH-GI-023
- Conditions
- Colorectal Cancer
- Keywords
- endostatin, chemotherapy, antiangiogenesis agent, colorectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Simcere Pharmaceutical Co., Ltd
- Study start
- Oct 2011
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 8 Feb 2012 (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.
Studies suggest that the addition of antiangiogenic agents to conventional therapeutic strategies, e.g., chemotherapy, radiation, or other tumor-targeting agents, will increase clinical efficacy. For advanced colorectal cancer,the antiangiogenic agent bevacizumab has become an important treatment option and its combination with chemotherapy is now being one of the standard first line therapy. This phase II study was conducted to determine the efficacy and safety of another antiangiogenesis inhibitor rh-endostatin plus mFOLFOX6 in advanced colorectal cancer.
Detailed description
Rh-Endostatin (Endostar; Simcere Pharmaceutical Co., Ltd, JiangSu,China) is a humanized recombinant endostatin which is a direct angiogenesis inhibitor targeting the microvascular endothelial cells (ECs). A pivotal phase III study completed in China demonstrated that the addition of rh-endostatin to navelbine plus cisplatin conferred clinically significant improvements in overall survival (OS), progression-free survival (PFS), as well as response rate (RR), in patients with previously untreated metastatic non small cell lung cancer (NSCLC). In vitro, the combination of Endostatin and fluorouracil showed synergistic activity in inhibiting colon cancer. MFolfox6 was standard first-line regimen in advanced colorectal cancer. The investigators carried out a phase II trial to investigate the activity and safety of rh-endostatin plus mFOLFOX in patients with metastatic colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: Endostatins (Endostar), Drug: Oxaliplatin, Drug: Leucovorin, Drug: 5-fluorouracil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent (IC)
- Age greater than or equal to 18 years
- Histologically or cytologically confirmed metastatic or recurrent colorectal tumors with no previous treatment for advanced disease.
- At least one measurable lesion according to the RECIST criteria which has not been irradiated (i.e. newly arising lesions in previously irradiated areas are accepted). Minimum indicator lesion size: > 10 mm measured by spiral CT or >20mm measured by conventional techniques
- ECOG performance status 0-1
Key exclusion criteria (17 listed)
- Pregnant or lactating woman
- Any prior oxaliplatin treatment, with the exception of adjuvant therapy given > 12 months prior to the beginning of study therapy,and any prior 5-fluorouracil treatment, with the exception of adjuvant therapy given > 6 months prior to the beginning of study therapy
- Any prior endostatin treatment
- known hypersensitivity to 5-fluorouracil,oxaliplatin,leucovorin
- History of persistent neurosensory disorder including but not limited to peripheral neuropathy
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 |
|---|---|---|
| Endostatins (Endostar)Also: Endostar7.5mg/m2 iv d1-10,repeat every 14 days,until progression or occurrence of untolerated toxicity | Drug | treatment |
| OxaliplatinAlso: Eloxatin85mg/m2 iv d1 ,repeat every 14 days,until progression or occurrence of untolerated toxicity | Drug | treatment |
| Leucovorin200mg/m2 iv d1 ,repeat every 14 days | Drug | treatment |
| 5-fluorouracil400mg/m2 iv bolus,then 2400mg/m2 continuous infusion for 46 hours,repeated every 14 days,until progression or occurrence of untolerated toxicity | Drug | treatment |
Primary outcome
response rate
Time frame: 3 years
From date of treatment was administered until the date of first documented response according to RECIST criteria
3 secondary outcomes
progression free survival
Time frame: 3 years
overall survival
Time frame: 3 years
Number of participants with adverse events
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2013.
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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.
Lin Yang, MD principal investigator
Cancer hospital&institute,Chinese Academy of Medical Sciences
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 Endostatins (Endostar), Oxaliplatin and Leucovorin in people with Colorectal Cancer, run by Chinese Academy of 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 17 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 27 Nov 2013. 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 Wen Zhang, MD (86-10-87788145, wenwen0605@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: 3 years). 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 27 Nov 2013.