Advanced NSCLCPhase 4NCT00813332
Second-line Therapy Study of Combined Chemotherapy and Endostar to Patients With Non-Small Cell Lung Cancer(NSCLC)
A Phase 4 study testing Endostar(rh recombinant endostatin) plus Docetaxel in people with Advanced NSCLC and Recurrent NSCLC, run by Simcere Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
The purpose of this study is to compare the efficacy and safety of Endostar (Recombinant Human Endostatin) combined with Docetaxel and single Docetaxel through multi-center, double-blinding, randomized controlled, phase Ⅳ clinical trial for NSCLC cases who have obvious progressive disease or intolerant adverse effects… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced NSCLC, Recurrent NSCLC
- What is being tested?
- Endostar(rh recombinant endostatin) plus Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Oct 2008to Oct 2010
- Phase
- Phase 4
- 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
- Age 18-75 years old, males or females;
- Patients with NSCLC confirmed by histopathology or cytology who need second-line chemotherapy, including progressive disease cases during or in 3 months posterior to end of first-line chemotherapy( at least 4 cycles done) and cases with intolerant adverse effects in first-line chemotherapy( at least 4 cycles done); neo-adjuvant chemotherapy and targeted therapy(EFGR-TKIs) not to be served as first-line chemotherapy; 3 months of clearance needed for neo-adjuvant chemotherapy and 1 month for targeted and first-line chemotherapy;
- Local advanced and metastatic cases with tumor foci that can be evaluated by CT, MRI or PET-CT; at least one diameter ≥ 1 cm (including metastatic lymph nodes) confirmed by CT scan or ≥ 1 cm by spin CT or PET-CT );
- No contraindication for chemotherapy, with normal peripheral hemogram, renal and hepatic function: Peripheral hemogram: WBC≥4.0×109/L，PLT≥80×109/L，Hgb≥90g/L； Renal function: serum BUN and creatinine ≤1.0×UNL; Hepatic function: transaminase≤1.5×UNL, BIL≤×UNL;
- Karnofsky performance scale≥60 or ECOG performance scale≤ 2; expected survival time≥3 months;
- No allergic history to biological agents and taxane agents;
- Patients are voluntary to participate and sign the informed contents.
Who cannot join
- Pregnant or breast-feeding females; or females who have reproductive ability but do not take contraception method;
- With severe acute infection uncontrolled; purulent or chronic infection with wounds difficult to recover;
- With history of severe heart diseases, including congestive heart failure, uncontrolled arrhythmia with high risk, unstable angina pectoris, myocardial infarction, severe cardiac valvular diseases and refractory hypertension;
- Patients with uncontrolled neurological, mental disease or psychosis, patients with poor compliance that cannot coordinate the therapy or describe the treatment response;
- Uncontrolled brain metastasis patients with obvious manifestations of intracranial hypertension or neurological and mental disorders;
- Uncontrolled diabetes and contraindication to corticoid agents;
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- Obvious hemorrhage tendency;
- Allergic to any drug in the trial;
- Patients with a second tumor;
- Patients participating in other clinical trials;
- Patients treated by Endostar or Docetaxel (excluding neo-chemotherapy) included combination chemotherapy previously;
- Foci to be evaluated for response in trial treated by radiation in 6 months.
- Other conditions that are regarded for exclusion by the trialists.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital of Tianjin Medical University
Tianjin, 300060
Kai LI, Professor, 0086-22-81351613, likai5@medmail.com.cn,likqupp@yahoo.com
Zhao YAN, Doctor, 0086-22-23948638(Fax23524155), yanzhaotj@126.com
About this study
Official title: A Double Blind , Randomized, Multicenter Study of Second Line Treatment of Endostar（rh Recombined Endostatin）With Single Docetaxel In NSCLC Patients
The purpose of this study is to compare the efficacy and safety of Endostar (Recombinant Human Endostatin) combined with Docetaxel and single Docetaxel through multi-center, double-blinding, randomized controlled, phase Ⅳ clinical trial for NSCLC cases who have obvious progressive disease or intolerant adverse effects in first-line chemotherapy.
Read the detailed description
The combinative therapy of Endostar, Vinorelbine and cisplatin has been shown to increase response rate and survival in patients (pts) with advanced NSCLC and is sFDA-approved for this indication. However, there are limited data on the safety and efficacy of Endostar in combination with other widely used chemotherapy doublets for 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. In this clinical trial, there will be 160 patients enrollment, giving Docetaxel (75mg/m2,iv, d1, every 3 weeks) plus Endostar(7.5mg/m2/day, iv, d1-d14, every 3 weeks) or Docetaxel with placebo. We'll evaluate the efficacy and safety of the Docetaxel plus Endostar treatment to NSCLC and hope to provide a promising regimen to advanced lung cancer patients.
- Conditions
- Advanced NSCLC, Recurrent NSCLC
- Being tested
- Endostar(rh recombinant endostatin) plus Docetaxel, Placebo plus Docetaxel
- Keywords
- Endostar, NSCLC, Docetaxel, Combined therapy, second-line chemotherapy
- 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(rh recombinant endostatin) plus DocetaxelDrug
Also called Experimental group
7.5mg/m2, IV( in the vein) on day1-14 of each 21-28 day cycle. Number of cycles: until progression or unacceptable toxicity develops.
Placebo plus DocetaxelDrug
Also called control group
Placebo plus Docetaxel
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Endostar combined with Docetaxel for Advanced NSCLC: All eligible patients will receive Endostar in combination with Docetaxel chemotherapy for 2 cycles (21 days for each cycle) and cases of good response(CR+PR+SD) will continue treatment for 2 cycles. Endostar treatment will continue after completion of first 4 cycles until disease progression. Receives: Drug: Endostar(rh recombinant endostatin) plus Docetaxel |
| 2 | Placebo comparator | Docetaxel combined with placebo for Advanced NSCLC: All eligible patients will receive placebo in combination with Docetaxel chemotherapy for 2 cycles (21 days for each cycle) and cases of good response(CR+PR+SD) will continue treatment for 2 cycles. Placebo will continue after completion of first 4 cycles until disease progression. Receives: Drug: Placebo plus Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival time,survival rate for 1 year
Measured: two years (2010.10)
Secondary outcomes (1)
Tumor response rate, disease controlled rate and adverse effects.
Measured: 1 year (2009.10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2009 (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 Advanced NSCLCStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Simcere Pharmaceutical Co., Ltd
- Sponsor type
- University, hospital or other
- Investigators
- Kai LI, professor, Principal investigator, Cancer Hospital of Tianjin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813332
- Sponsor's protocol ID
- simcere002
- Other IDs
- simcere0802
- Status last verified
- Dec 2009
- First submitted
- 19 Dec 2008
- Last updated
- 25 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind , Randomized, Multicenter Study of Second Line Treatment of Endostar（rh Recombined Endostatin）With Single Docetaxel In NSCLC Patients
- ClinicalTrials.gov ID
- NCT00813332
- Acronym / sponsor ID
- simcere002
- Conditions
- Advanced NSCLC, Recurrent NSCLC
- Keywords
- Endostar, NSCLC, Docetaxel, Combined therapy, second-line chemotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Simcere Pharmaceutical Co., LtdUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 23 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.
The purpose of this study is to compare the efficacy and safety of Endostar (Recombinant Human Endostatin) combined with Docetaxel and single Docetaxel through multi-center, double-blinding, randomized controlled, phase Ⅳ clinical trial for NSCLC cases who have obvious progressive disease or intolerant adverse effects in first-line chemotherapy.
Detailed description
The combinative therapy of Endostar, Vinorelbine and cisplatin has been shown to increase response rate and survival in patients (pts) with advanced NSCLC and is sFDA-approved for this indication. However, there are limited data on the safety and efficacy of Endostar in combination with other widely used chemotherapy doublets for 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. In this clinical trial, there will be 160 patients enrollment, giving Docetaxel (75mg/m2,iv, d1, every 3 weeks) plus Endostar(7.5mg/m2/day, iv, d1-d14, every 3 weeks) or Docetaxel with placebo. We'll evaluate the efficacy and safety of the Docetaxel plus Endostar treatment to NSCLC and hope to provide a promising regimen to advanced lung cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Endostar(rh recombinant endostatin) plus DocetaxelEndostar combined with Docetaxel for Advanced NSCLC: All eligible patients will receive Endostar in combination with Docetaxel chemotherapy for 2 cycles (21 days for each cycle) and cases of good response(CR+PR+SD) will continue treatment for 2 cycles. Endostar treatment will continue after completion of first 4 cycles until disease progression. |
| 2 | Placebo comparator | Drug: Placebo plus DocetaxelDocetaxel combined with placebo for Advanced NSCLC: All eligible patients will receive placebo in combination with Docetaxel chemotherapy for 2 cycles (21 days for each cycle) and cases of good response(CR+PR+SD) will continue treatment for 2 cycles. Placebo will continue after completion of first 4 cycles until disease progression. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-75 years old, males or females;
- Patients with NSCLC confirmed by histopathology or cytology who need second-line chemotherapy, including progressive disease cases during or in 3 months posterior to end of first-line chemotherapy( at least 4 cycles done) and cases with intolerant adverse effects in first-line chemotherapy( at least 4 cycles done); neo-adjuvant chemotherapy and targeted therapy(EFGR-TKIs) not to be served as first-line chemotherapy; 3 months of clearance needed for neo-adjuvant chemotherapy and 1 month for targeted and first-line chemotherapy;
- Local advanced and metastatic cases with tumor foci that can be evaluated by CT, MRI or PET-CT; at least one diameter ≥ 1 cm (including metastatic lymph nodes) confirmed by CT scan or ≥ 1 cm by spin CT or PET-CT );
- No contraindication for chemotherapy, with normal peripheral hemogram, renal and hepatic function: Peripheral hemogram: WBC≥4.0×109/L，PLT≥80×109/L，Hgb≥90g/L； Renal function: serum BUN and creatinine ≤1.0×UNL; Hepatic function: transaminase≤1.5×UNL, BIL≤×UNL;
- Karnofsky performance scale≥60 or ECOG performance scale≤ 2; expected survival time≥3 months;
Key exclusion criteria (13 listed)
- Pregnant or breast-feeding females; or females who have reproductive ability but do not take contraception method;
- With severe acute infection uncontrolled; purulent or chronic infection with wounds difficult to recover;
- With history of severe heart diseases, including congestive heart failure, uncontrolled arrhythmia with high risk, unstable angina pectoris, myocardial infarction, severe cardiac valvular diseases and refractory hypertension;
- Patients with uncontrolled neurological, mental disease or psychosis, patients with poor compliance that cannot coordinate the therapy or describe the treatment response;
- Uncontrolled brain metastasis patients with obvious manifestations of intracranial hypertension or neurological and mental disorders;
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(rh recombinant endostatin) plus DocetaxelAlso: Experimental group7.5mg/m2, IV( in the vein) on day1-14 of each 21-28 day cycle. Number of cycles: until progression or unacceptable toxicity develops. | Drug | 1 |
| Placebo plus DocetaxelAlso: control groupPlacebo plus Docetaxel | Drug | 2 |
Primary outcome
Progression-free survival time,survival rate for 1 year
Time frame: two years (2010.10)
1 secondary outcome
Tumor response rate, disease controlled rate and adverse effects.
Time frame: 1 year (2009.10)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2010.
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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.
Kai LI, professor principal investigator
Cancer Hospital of Tianjin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Endostar(rh recombinant endostatin) plus Docetaxel in people with Advanced NSCLC and Recurrent NSCLC, run by Simcere Pharmaceutical Co., Ltd 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 13 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 25 Jan 2010. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Kai LI, Professor (0086-22-81351613, likai5@medmail.com.cn, likqupp@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival time,survival rate for 1 year (time frame: two years (2010.10)). 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 25 Jan 2010.