Advanced Non-small Cell Lung CancerPhase 2NCT00708812
Paclitaxel Plus Carboplatin With or Without Endostar in Patients With Advanced Non-small Cell Lung Cancer
A Phase 2 study testing Endostar(Recombinant Human Endostatin Injection) and paclitaxel-carboplatin in people with Advanced Non-small Cell Lung Cancer, run by Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd at 1 site in China.
Trial summary
In this randomized, double-blind, placebo-controlled, multicentre trial, 126 patients between July 5, 2007 and July 30, 2008 were enrolled from 10 centers. The leader units are Shanghai Chest Hospital Affiliated to Shanghai Jiao-Tong University and Shanghai Changzheng Hospital. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Non-small Cell Lung Cancer
- What is being tested?
- Endostar(Recombinant Human Endostatin Injection) and paclitaxel-carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- Jul 2007to Dec 2009
- 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, previously untreated stage IIIB or IV NSCLC
- age of 18-75 years
- at least one measurable lesion (RECIST)
- patients evaluated as SD or above after 1 cycle (21 days) of TC chemotherapy .
- adequate hematologic, cardiac, renal, and hepatic function
- ECOG PS 0-2
Who cannot join
- symptomatic brain metastases
- bone metastases with complications
- major organ dysfunction
- bleeding diathesis or coagulopathy
- pregnant or lactating woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Paclitaxel Plus Carboplatin (TC) Versus TC Plus Endostar in Patients With Advanced Non-small Cell Lung Cancer(NSCLC): a Randomized, Double-blind, Placebo-controlled, Multicentre Study
In this randomized, double-blind, placebo-controlled, multicentre trial, 126 patients between July 5, 2007 and July 30, 2008 were enrolled from 10 centers. The leader units are Shanghai Chest Hospital Affiliated to Shanghai Jiao-Tong University and Shanghai Changzheng Hospital. All eligible patients received 1 cycle (21 days) of TC chemotherapy. After chemotherapy, patients evaluated as SD (Stable Disease) or above were randomized to receive endostar plus TC or TC alone for 3 cycles, 21 days as one cycle.
- Conditions
- Advanced Non-small Cell Lung Cancer
- Being tested
- Endostar(Recombinant Human Endostatin Injection), paclitaxel-carboplatin
- Keywords
- Non-small Cell Lung Cancer, Endostar, Paclitaxel, 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(Recombinant Human Endostatin Injection)Drug
Endostar 7.5mg/m2 on d8-d21 in each 21-day cycle
paclitaxel-carboplatinDrug
paclitaxel, 175mg/m2, iv, d1, q3w; carboplatin, AUC 5, iv, d1, q3w
| Study group | Role | What they receive |
|---|---|---|
| The control group | Active comparator | paclitaxel-carboplatin Receives: Drug: paclitaxel-carboplatin |
| The treatment group | Experimental | paclitaxel-carboplatin plus Endostar Receives: Drug: Endostar(Recombinant Human Endostatin Injection); Drug: paclitaxel-carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
Measured: every 2 months until disease progression
Secondary outcomes (2)
Objective Response Rate (ORR)
Measured: the end of each cycle
Overall Survival (OS)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2008 (estimated)
- Study startJul 2007
- Primary completionSep 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00708812
- Sponsor's protocol ID
- XYL014
- Status last verified
- Jul 2011
- First submitted
- 21 Jun 2008
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paclitaxel Plus Carboplatin (TC) Versus TC Plus Endostar in Patients With Advanced Non-small Cell Lung Cancer(NSCLC): a Randomized, Double-blind, Placebo-controlled, Multicentre Study
- ClinicalTrials.gov ID
- NCT00708812
- Acronym / sponsor ID
- XYL014
- Conditions
- Advanced Non-small Cell Lung Cancer
- Keywords
- Non-small Cell Lung Cancer, Endostar, Paclitaxel, Carboplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Shandong Simcere-Medgenn Bio-pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 2 Jul 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.
In this randomized, double-blind, placebo-controlled, multicentre trial, 126 patients between July 5, 2007 and July 30, 2008 were enrolled from 10 centers. The leader units are Shanghai Chest Hospital Affiliated to Shanghai Jiao-Tong University and Shanghai Changzheng Hospital. All eligible patients received 1 cycle (21 days) of TC chemotherapy. After chemotherapy, patients evaluated as SD (Stable Disease) or above were randomized to receive endostar plus TC or TC alone for 3 cycles, 21 days as one cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The control group | Active comparator | Drug: paclitaxel-carboplatinpaclitaxel-carboplatin |
| The treatment group | Experimental | Drug: Endostar(Recombinant Human Endostatin Injection), Drug: paclitaxel-carboplatinpaclitaxel-carboplatin plus Endostar |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- histologically or cytologically confirmed, previously untreated stage IIIB or IV NSCLC
- age of 18-75 years
- at least one measurable lesion (RECIST)
- patients evaluated as SD or above after 1 cycle (21 days) of TC chemotherapy .
- adequate hematologic, cardiac, renal, and hepatic function
Key exclusion criteria (5 listed)
- symptomatic brain metastases
- bone metastases with complications
- major organ dysfunction
- bleeding diathesis or coagulopathy
- pregnant or lactating woman
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(Recombinant Human Endostatin Injection)Endostar 7.5mg/m2 on d8-d21 in each 21-day cycle | Drug | The treatment group |
| paclitaxel-carboplatinpaclitaxel, 175mg/m2, iv, d1, q3w; carboplatin, AUC 5, iv, d1, q3w | Drug | The control group, The treatment group |
Primary outcome
Progression-free Survival (PFS)
Time frame: every 2 months until disease progression
2 secondary outcomes
Objective Response Rate (ORR)
Time frame: the end of each cycle
Overall Survival (OS)
Time frame: 2 years
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 21 Jul 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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(Recombinant Human Endostatin Injection) and paclitaxel-carboplatin in people with Advanced Non-small Cell Lung Cancer, run by Shandong Simcere-Medgenn Bio-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 6 inclusion and 5 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 21 Jul 2011. 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?
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 (PFS) (time frame: every 2 months until disease progression). 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 21 Jul 2011.