Stage III Non-small-Cell Lung CancerPhase 1/2NCT01733589
Recombinant Human Endostatin Continued Pumping Into Vein Combining With CCRT in Unresectable Stage III NSCLC
A Phase 1/2 study testing Recombinant human endostatin, Etoposide (50mg/m2) IV (in the vein) on day 1 to day 5 of a 28-day cycle for 2 cycles and cisplatinum (50mg/m2) IV (in the vein) on day 1 and day 8 of a 28-day cycle for 2 cycles in people with Stage III Non-small-Cell Lung Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
Resistance of hypoxic tumor cells to radiation is a significant reason of failure in the local control of tumors, especially the squamous cell carcinomas. Preclinical models have shown that Endostar may transiently "normalize" the tumor vasculature to make it more efficient for oxygen delivery, thereby providing a… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stage III Non-small-Cell Lung Cancer
- What is being tested?
- Recombinant human endostatin, Etoposide (50mg/m2) IV (in the vein) on day 1 to day 5 of a 28-day cycle for 2 cycles and cisplatinum (50mg/m2) IV (in the vein) on day 1 and day 8 of a 28-day cycle for 2 cycles
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteChina
- Study dates
- Nov 2012to Jun 2015
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- untreated histologic or cytologic of NSCLC verified
- inoperable stage IIIA or IIIB NSCLC
- measurable disease by RECIST
- 18~70 years of age
- an ECOG PS of 0 to 1
- absolute neutrophil count (ANC) of ≥1500/μL, hemoglobin ≥10gm/dL, platelet ≥100,000/μL
Show all 11Show fewer
- serum creatinine ≤1.25 times of upper limit of normal (ULN), calculated creatinine clearance (CrCl) of ≥60ml/min
- bilirubin 1.5×ULN, AST and ALT less than 2.5×ULN, alkaline phosphatase less than 5×ULN
- forced vital capacity in 1 second (FEV1) higher than 0.8 L
- CB6 is normal
- Written informed consent
Who cannot join
- a history of other malignant diseases
- any contraindications for chemoradiotherapy
- distant metastasis
- malignant pleural and/or pericardial effusion
- pregnant or nursing
- preexisting bleeding diatheses or coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Phase I/II Clinical Trial of Recombinant Human Endostatin Continued Pumping Into Vein Combining With Concurrent Chemo-Radiotherapy in the Patients With Unresectable Stage III Non-small-Cell Lung Cancer
Resistance of hypoxic tumor cells to radiation is a significant reason of failure in the local control of tumors, especially the squamous cell carcinomas. Preclinical models have shown that Endostar may transiently "normalize" the tumor vasculature to make it more efficient for oxygen delivery, thereby providing a window of opportunity for enhanced sensitivity to radiation treatment. This study is to evaluate the safety, toxicity, and efficacy of the addition of Endostar Continued Pumping into Vein to the standard CCRT regimen in patients with unresectable stage III NSCLC.
Read the detailed description
Primary
Evaluate the efficacy and safety of Endostar combined with concurrent chemo-radiotherapy (CCRT) in patients with unresectable stage III non-small-cell lung cancer (NSCLC).
Secondary
Measure changes in VEGF and other angiogenic cytokines and antiangiogenic factors in plasma samples from these patients.
Evaluate the application of CT perfusion imaging to determine changes in tumor vascular mophology and function during treatment.
- Conditions
- Stage III Non-small-Cell Lung Cancer
- Being tested
- Recombinant human endostatin, Etoposide (50mg/m2) IV (in the vein) on day 1 to day 5 of a 28-day cycle for 2 cycles, cisplatinum (50mg/m2) IV (in the vein) on day 1 and day 8 of a 28-day cycle for 2 cycles, laboratory biomarker analysis, CT perfusion imaging
- Keywords
- Recombinant human endostatin, Non-small-Cell Lung Cancer, chemoradiotherapy
- 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.
Recombinant human endostatinDrug
Recombinant human endostatin(7.5mg/m2/24h) Continued Pumping Into Vein through 5 days at week 1, 3, 5, and 7,combined with concurrent chemo-radiotherapy.
Etoposide (50mg/m2) IV (in the vein) on day 1 to day 5 of a 28-day cycle for 2 cyclesDrug
cisplatinum (50mg/m2) IV (in the vein) on day 1 and day 8 of a 28-day cycle for 2 cyclesDrug
laboratory biomarker analysisOther
CT perfusion imagingOther
| Study group | Role | What they receive |
|---|---|---|
| Recombinant Human Endostatin | Experimental | All patients received recombinant human endostatin(7.5mg/m2/24h) Continued Pumping Into Vein through 5 days at week 1, 3, 5, and 7. During week 2 through 8, patients received etoposide 50mg/m2 days 1-5 and cisplatin 50mg/m2 on day 1,8, every 4 weeks for two cycles with concurrent thoracic radiation at 60~66Gy in 30~33 fractions for 6~7 weeks. Receives: Drug: Recombinant human endostatin; Drug: Etoposide (50mg/m2) IV (in the vein) on day 1 to day 5 of a 28-day cycle for 2 cycles; Drug: cisplatinum (50mg/m2) IV (in the vein) on day 1 and day 8 of a 28-day cycle for 2 cycles; Other: laboratory biomarker analysis; Other: CT perfusion imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
from beginning treatment to progressive disease or the last follow-up
Measured: 2-year
Secondary outcomes (3)
Response rate
complete response(CR); partial response(PR); stable disease(SD); progressive disease(PD)
Measured: 1 month
overall survival
from date of beginning treatment until date of death
Measured: 5 years
treatment related toxicities
radiation-induced esophagitis; radiation-induced pneumonia
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Fudan University, Peking University Cancer Hospital & Institute, Tianjin Medical University Cancer Institute and Hospital, Shandong Cancer Hospital and Institute, Jiangsu Cancer Institute & Hospital, Fujian Cancer Hospital, The First People's Hospital of Lianyungang
- Responsible party
- Sponsor
- Investigators
- Ming Chen, M.D., Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733589
- Sponsor's protocol ID
- [2012]-10-24
- Status last verified
- Jul 2017
- First submitted
- 2 Nov 2012
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase I/II Clinical Trial of Recombinant Human Endostatin Continued Pumping Into Vein Combining With Concurrent Chemo-Radiotherapy in the Patients With Unresectable Stage III Non-small-Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01733589
- Acronym / sponsor ID
- [2012]-10-24
- Conditions
- Stage III Non-small-Cell Lung Cancer
- Keywords
- Recombinant human endostatin, Non-small-Cell Lung Cancer, chemoradiotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Fudan University, Peking University Cancer Hospital & Institute, Tianjin Medical University Cancer Institute and Hospital, Shandong Cancer Hospital and Institute, Jiangsu Cancer Institute & Hospital, Fujian Cancer Hospital, The First People's Hospital of Lianyungang
- Study start
- Nov 2012 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 27 Nov 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.
Resistance of hypoxic tumor cells to radiation is a significant reason of failure in the local control of tumors, especially the squamous cell carcinomas. Preclinical models have shown that Endostar may transiently "normalize" the tumor vasculature to make it more efficient for oxygen delivery, thereby providing a window of opportunity for enhanced sensitivity to radiation treatment. This study is to evaluate the safety, toxicity, and efficacy of the addition of Endostar Continued Pumping into Vein to the standard CCRT regimen in patients with unresectable stage III NSCLC.
Detailed description
Primary
Evaluate the efficacy and safety of Endostar combined with concurrent chemo-radiotherapy (CCRT) in patients with unresectable stage III non-small-cell lung cancer (NSCLC).
Secondary
Measure changes in VEGF and other angiogenic cytokines and antiangiogenic factors in plasma samples from these patients.
Evaluate the application of CT perfusion imaging to determine changes in tumor vascular mophology and function during treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recombinant Human Endostatin | Experimental | Drug: Recombinant human endostatin, Drug: Etoposide (50mg/m2) IV (in the vein) on day 1 to day 5 of a 28-day cycle for 2 cycles, Drug: cisplatinum (50mg/m2) IV (in the vein) on day 1 and day 8 of a 28-day cycle for 2 cycles, Other: laboratory biomarker analysis, Other: CT perfusion imagingAll patients received recombinant human endostatin(7.5mg/m2/24h) Continued Pumping Into Vein through 5 days at week 1, 3, 5, and 7. During week 2 through 8, patients received etoposide 50mg/m2 days 1-5 and cisplatin 50mg/m2 on day 1,8, every 4 weeks for two cycles with concurrent thoracic radiation at 60~66Gy in 30~33 fractions for 6~7 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- untreated histologic or cytologic of NSCLC verified
- inoperable stage IIIA or IIIB NSCLC
- measurable disease by RECIST
- 18~70 years of age
- an ECOG PS of 0 to 1
Key exclusion criteria (6 listed)
- a history of other malignant diseases
- any contraindications for chemoradiotherapy
- distant metastasis
- malignant pleural and/or pericardial effusion
- pregnant or nursing
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 |
|---|---|---|
| Recombinant human endostatinRecombinant human endostatin(7.5mg/m2/24h) Continued Pumping Into Vein through 5 days at week 1, 3, 5, and 7,combined with concurrent chemo-radiotherapy. | Drug | Recombinant Human Endostatin |
| Etoposide (50mg/m2) IV (in the vein) on day 1 to day 5 of a 28-day cycle for 2 cycles | Drug | Recombinant Human Endostatin |
| cisplatinum (50mg/m2) IV (in the vein) on day 1 and day 8 of a 28-day cycle for 2 cycles | Drug | Recombinant Human Endostatin |
| laboratory biomarker analysis | Other | Recombinant Human Endostatin |
| CT perfusion imaging | Other | Recombinant Human Endostatin |
Primary outcome
progression-free survival
Time frame: 2-year
from beginning treatment to progressive disease or the last follow-up
3 secondary outcomes
Response rate
Time frame: 1 month
overall survival
Time frame: 5 years
treatment related toxicities
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
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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.
Ming Chen, M.D. 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 1/2 study testing Recombinant human endostatin, Etoposide (50mg/m2) IV (in the vein) on day 1 to day 5 of a 28-day cycle for 2 cycles and cisplatinum (50mg/m2) IV (in the vein) on day 1 and day 8 of a 28-day cycle for 2 cycles in people with Stage III Non-small-Cell Lung 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 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: finished, as of the sponsor's last update on 14 Jul 2017. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: 2-year). 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 14 Jul 2017.