Non-small Cell Lung CancerPhase 2NCT01669707
Endostar Durative Transfusion Combining With Gemcitabine-Cisplatin to Treat Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Endostar -Continued Pumping into+GP and Endostar -injecting into +GP in people with Non-small Cell Lung Cancer, run by Beijing Chest Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether Endostar pumping into vein with Gemcitabine-Cisplatin are more effective than Endostar with Gemcitabine-Cisplatin regularly in the treatment of Non-Small Cell Lung Cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Endostar -Continued Pumping into+GP and Endostar -injecting into +GP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Apr 2011to Sep 2020
- 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 diagnosed NSCLC;
- primary treatment,inoperable stage IIIB/IV NSCLC;
- Age of 18-75years; Gender Not Required;
- Adequate hematologic, renal, and hepatic function ,Specific index as follows:
- liver function: S-Bilirubin ≤1.5 ULN ; Transaminase≤2 ULN. renal function: S-Creatinine ≤1.2 ULN; blood urea nitrogen ≤1.2 ULN . ULN: upper normal limit. Marrow Hemopoietic Function: WBC≥4.0×10^9/l, ANC≥2.0×10^9/l platelet count ≥100×10^9/l, Hb≥100 g/l;
- ECOG PS 0-2,Life expectancy ≥ 3 months; endure more than two cycle chemotherapy;
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- The patients have explicit lung tumor lesions and the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, MRI);
- No history of serious drug allergy;
- Informed consent should be obtained before treatment.
Who cannot join
- Symptomatic brain metastases with cognitive disorder,bone metastases with complications;
- Major organ dysfunction and Serious Heart Disease( congestive heart-failure,incontrollable high-risk arrhythmia,unstable angina, valvular disease, myocardial infarct and Resistant hypertension,);
- Serious complications and investigator consider it is unsuited enrolling;
- Pregnant or lactating women;
- Allergic to research drug;
- participating in other experimental trials and receive the treatment in four weeks;
- The position that is for observing curative effect have a radiotherapy.
Trial locations and contacts
1 site in 1 country.
Liyan Xu, MD contact
China1 site, 1 recruiting
- Recruiting
The Beijing Chest Hospital
Beijing
Liyan Xu, MD, xuliyan2009@yahoo.cn
Liyan Xu, MD
About this study
The purpose of this study is to determine whether Endostar pumping into vein with Gemcitabine-Cisplatin are more effective than Endostar with Gemcitabine-Cisplatin regularly in the treatment of Non-Small Cell Lung Cancer (NSCLC).
Read the detailed description
Endostar have anti-tumor activity by against vascular endothelial growth factor for initial treatment. This study was designed to evaluate the safety and efficacy of Endostar Continued vein-pumping Combining with Gemcitabine-Cisplatin (GP)chemotherapy in patients with NSCLC,and seeking for more effective injection.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Endostar -Continued Pumping into+GP, Endostar -injecting into +GP
- Keywords
- Endostar, advanced Non-small cell lung cancer, Continued Pumping into vein, Gemcitabine, Carboplatin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endostar -Continued Pumping into+GPDrug
Gemcitabine(G):1000mg/m2 intravenous injection on d1,8 q3w; Cisplatin (P):75mg d1 q3w; Endostar:7.5 mg/m2 Continued Pumping into vein with saline,Each pump use 120 hours and the dosage is 7.5mg/m2*5 ,on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle,Continued using 2-4cycles.
Endostar -injecting into +GPDrug
Gemcitabine(G):1000mg/m2 intravenous injection on d1,8 q3w; Cisplatin (P):75mg iv on d1 q3w; Endostar:7.5 mg/m2 injecting into vein for 4 hours with saline on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle.Continued using 2-4cycles
| Study group | Role | What they receive |
|---|---|---|
| Endostar -Continued Pumping into+GP | Experimental | Endostar that is Continued Pumping into vein Combining With Gemcitabine -Cisplatin Receives: Drug: Endostar -Continued Pumping into+GP |
| Endostar -injecting into +GP | Active comparator | Endostar that is injecting into vein with Gemcitabine -Cisplatin Receives: Drug: Endostar -injecting into +GP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Measured: two years
Secondary outcomes (3)
Overall survival (OS)
Measured: two years
Clinical benefit rate (CBR)
Measured: two years
Number of Participants With Adverse Events(AE) as a Measure of Safety and Tolerability
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startApr 2011
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liyan Xu, Beijing Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669707
- Sponsor's protocol ID
- BeijingCH001
- Status last verified
- Sep 2018
- First submitted
- 13 Aug 2012
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endostar Durative Transfusion Combining With Gemcitabine-Cisplatin to Treat Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT01669707
- Acronym / sponsor ID
- BeijingCH001
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Endostar, advanced Non-small cell lung cancer, Continued Pumping into vein, Gemcitabine, Carboplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing Chest HospitalUniversity, hospital or other
- Study start
- Apr 2011 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 21 Aug 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.
The purpose of this study is to determine whether Endostar pumping into vein with Gemcitabine-Cisplatin are more effective than Endostar with Gemcitabine-Cisplatin regularly in the treatment of Non-Small Cell Lung Cancer (NSCLC).
Detailed description
Endostar have anti-tumor activity by against vascular endothelial growth factor for initial treatment. This study was designed to evaluate the safety and efficacy of Endostar Continued vein-pumping Combining with Gemcitabine-Cisplatin (GP)chemotherapy in patients with NSCLC,and seeking for more effective injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endostar -Continued Pumping into+GP | Experimental | Drug: Endostar -Continued Pumping into+GPEndostar that is Continued Pumping into vein Combining With Gemcitabine -Cisplatin |
| Endostar -injecting into +GP | Active comparator | Drug: Endostar -injecting into +GPEndostar that is injecting into vein with Gemcitabine -Cisplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically diagnosed NSCLC;
- primary treatment,inoperable stage IIIB/IV NSCLC;
- Age of 18-75years; Gender Not Required;
- Adequate hematologic, renal, and hepatic function ,Specific index as follows:
- liver function: S-Bilirubin ≤1.5 ULN ; Transaminase≤2 ULN. renal function: S-Creatinine ≤1.2 ULN; blood urea nitrogen ≤1.2 ULN . ULN: upper normal limit. Marrow Hemopoietic Function: WBC≥4.0×10^9/l, ANC≥2.0×10^9/l platelet count ≥100×10^9/l, Hb≥100 g/l;
Key exclusion criteria (7 listed)
- Symptomatic brain metastases with cognitive disorder,bone metastases with complications;
- Major organ dysfunction and Serious Heart Disease( congestive heart-failure,incontrollable high-risk arrhythmia,unstable angina, valvular disease, myocardial infarct and Resistant hypertension,);
- Serious complications and investigator consider it is unsuited enrolling;
- Pregnant or lactating women;
- Allergic to research drug;
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 -Continued Pumping into+GPGemcitabine(G):1000mg/m2 intravenous injection on d1,8 q3w; Cisplatin (P):75mg d1 q3w; Endostar:7.5 mg/m2 Continued Pumping into vein with saline,Each pump use 120 hours and the dosage is 7.5mg/m2*5 ,on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle,Continued using 2-4cycles. | Drug | Endostar -Continued Pumping into+GP |
| Endostar -injecting into +GPGemcitabine(G):1000mg/m2 intravenous injection on d1,8 q3w; Cisplatin (P):75mg iv on d1 q3w; Endostar:7.5 mg/m2 injecting into vein for 4 hours with saline on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle.Continued using 2-4cycles | Drug | Endostar -injecting into +GP |
Primary outcome
Progression free survival (PFS)
Time frame: two years
3 secondary outcomes
Overall survival (OS)
Time frame: two years
Clinical benefit rate (CBR)
Time frame: two years
Number of Participants With Adverse Events(AE) as a Measure of Safety and Tolerability
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
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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.
Liyan Xu, MD contact
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 -Continued Pumping into+GP and Endostar -injecting into +GP in people with Non-small Cell Lung Cancer, run by Beijing Chest 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 9 inclusion and 7 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 Sep 2018. 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 Liyan Xu, MD (xuliyan2009@yahoo.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: two 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 5 Sep 2018.