Metastatic Colorectal CancerPhase 2NCT01832948
Endostar Combined With mFOLFOX6 for First-line Treatment of Metastatic Colorectal Cancer
A Phase 2 study testing Endostar, Oxaliplatin and Folinic acid in people with Metastatic Colorectal Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
This study is to assess the efficacy and safety of Endostar combined with mFOLFOX6 in untreated metastatic colorectal cancer patients, and to find the markers that may predict the efficacy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Endostar, Oxaliplatin and Folinic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Jan 2015
- 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
- Histologically or cytologically confirmed metastatic colorectal cancer (adenocarcinoma)
- At least one measurable lesion (RECIST criteria)
- Life expectancy ≥ 3 months
- ECOG performance status 0-2
- Adequate hematologic function: ANC ≥ 1.5×109 /L，Hb ≥ 90 g/L，PLT ≥ 100×109 /L
- Adequate renal function: Cr ≤ 1.25×ULN or Creatinine clearance ≥ 60 ml/min
Show all 11Show fewer
- Adequate hepatic function: BIL ≤ 1.5×ULN, ALT/AST ≤ 2.5×ULN, Alkaline phosphatase ≤ 5×ULN
- Patients have not previously received palliative chemotherapy, immunological/ biological treatment
- No adjuvant chemotherapy in last six months
- Target lesion has not received local radiotherapy
- Written informed consent
Who cannot join
- Diagnosis of colorectal neuroendocrine tumor, undifferentiated carcinoma, adenosquamous carcinoma, squamous cell carcinoma
- Evidence of serious or uncontrolled infection
- Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
- Pregnant or lactating women
- Women of childbearing potential refused to practice acceptable methods of birth control to prevent pregnancy
- Allergic to any of the study drug
- Intestinal obstruction, intestinal perforation, or stroke within 3 months
- Participation in other clinical studies
Trial locations and contacts
1 site in 1 country.
Liming Zhu, MD contact
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Liming Zhu, MD, 0571-88122222
Liming Zhu, MD
About this study
Official title: Study of Endostar Combined With mFOLFOX6 for First-line Treatment of Metastatic Colorectal Cancer and Efficacy Prediction
This study is to assess the efficacy and safety of Endostar combined with mFOLFOX6 in untreated metastatic colorectal cancer patients, and to find the markers that may predict the efficacy.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Endostar, Oxaliplatin, Folinic acid, 5-FU
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndostarDrug
OxaliplatinDrug
Folinic acidDrug
5-FUDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Endostar d1-d7 15mg/d Oxaliplatin 85 mg/m2 d6 Folinic acid 400 mg/m2 d6 5-FU 400 mg/m2 d6, and then 5-FU 2,400 mg/m2 INTRAVENOUS over 46 h Receives: Drug: Endostar; Drug: Oxaliplatin; Drug: Folinic acid; Drug: 5-FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Measured: the end of the 3rd cycle
Secondary outcomes (3)
Blood perfusion in tumor tissue
Measured: baseline, the end of the 3rd cycle
Ratio of blood perfusion in tumor tissue to blood perfusion in surrounding normal tissue
Measured: baseline, the end of the 3rd cycle
Incidence of Adverse Events
Measured: up to 1 month after the last cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (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.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- 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
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liming Zhu, MD, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832948
- Sponsor's protocol ID
- 20121201E-mCRC
- Status last verified
- Apr 2013
- First submitted
- 31 Mar 2013
- Last updated
- 16 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Endostar Combined With mFOLFOX6 for First-line Treatment of Metastatic Colorectal Cancer and Efficacy Prediction
- ClinicalTrials.gov ID
- NCT01832948
- Acronym / sponsor ID
- 20121201E-mCRC
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 16 Apr 2013 (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.
This study is to assess the efficacy and safety of Endostar combined with mFOLFOX6 in untreated metastatic colorectal cancer patients, and to find the markers that may predict the efficacy.
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: Endostar, Drug: Oxaliplatin, Drug: Folinic acid, Drug: 5-FUEndostar d1-d7 15mg/d Oxaliplatin 85 mg/m2 d6 Folinic acid 400 mg/m2 d6 5-FU 400 mg/m2 d6, and then 5-FU 2,400 mg/m2 INTRAVENOUS over 46 h |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically or cytologically confirmed metastatic colorectal cancer (adenocarcinoma)
- At least one measurable lesion (RECIST criteria)
- Life expectancy ≥ 3 months
- ECOG performance status 0-2
- Adequate hematologic function: ANC ≥ 1.5×109 /L，Hb ≥ 90 g/L，PLT ≥ 100×109 /L
Key exclusion criteria (8 listed)
- Diagnosis of colorectal neuroendocrine tumor, undifferentiated carcinoma, adenosquamous carcinoma, squamous cell carcinoma
- Evidence of serious or uncontrolled infection
- Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
- Pregnant or lactating women
- Women of childbearing potential refused to practice acceptable methods of birth control to prevent pregnancy
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 |
|---|---|---|
| Endostar | Drug | Treatment |
| Oxaliplatin | Drug | Treatment |
| Folinic acid | Drug | Treatment |
| 5-FU | Drug | Treatment |
Primary outcome
Objective Response Rate (ORR)
Time frame: the end of the 3rd cycle
3 secondary outcomes
Blood perfusion in tumor tissue
Time frame: baseline, the end of the 3rd cycle
Ratio of blood perfusion in tumor tissue to blood perfusion in surrounding normal tissue
Time frame: baseline, the end of the 3rd cycle
Incidence of Adverse Events
Time frame: up to 1 month after the last cycle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2013.
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.
Liming Zhu, MD contact
Liming Zhu, MD principal investigator
Zhejiang Cancer Hospital
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 Endostar, Oxaliplatin and Folinic acid in people with Metastatic Colorectal Cancer, run by Zhejiang Cancer Hospital 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 11 inclusion and 8 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 16 Apr 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 Liming Zhu, MD (0571-88122222), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: the end of the 3rd cycle). 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 16 Apr 2013.