Small Cell Lung CancerPhase 2NCT00912392
Etoposide-Carboplatin Alone or With Endostar for Extensive Disease Small Cell Lung Cancer (ED-SCLC)
A Phase 2 study testing Endostar and Etoposide-Carboplatin in people with Small Cell Lung Cancer, run by Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd at 1 site in China.
Trial summary
Background: The effect of existing treatment modalities of extensive disease small-cell lung cancer (ED-SCLC) is unsatisfactory. Progress of new strategies including more efficient therapy is wanted. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Endostar and Etoposide-Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- May 2009to Dec 2012
- 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 SCLC;
- Age of 18-75 years;
- Life expectancy > 3 months;
- Adequate hematologic, renal, and hepatic function;
- ECOG PS 0-2;
Who cannot join
- Brain metastases;
- Clinically significant cardiovascular disease;
- Presence of hepatic and renal dysfunction;
- Evidence of bleeding diathesis or coagulopathy
- Pregnant or lactating woman;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etoposide-Carboplatin (EC) Versus EC Plus Endostar in Patients With Extensive Disease Small Cell Lung Cancer (ED-SCLC): Randomized, Open Label, Placebo-controlled, Multicentre Study
Background:
The effect of existing treatment modalities of extensive disease small-cell lung cancer (ED-SCLC) is unsatisfactory. Progress of new strategies including more efficient therapy is wanted. Endostar® (Rh-endostatin Injection) may 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® combined with etoposide-carboplatin (EC) chemotherapy in patients with ED-SCLC seeking for more effective treatment.
Read the detailed description
Methods:
In this randomized, open label, placebo-controlled, multicentre trial, 120 patients are planned to be enrolled at random into 2 arms(1:1) from 10 centers between June 2009 and June 2011. The leader units are Shanghai Chest Hospital Affiliated to Shanghai Jiao-Tong University. Main eligibility criteria are histological or cytological diagnosis of ED-SCLC, with an age of 18-75 years. All eligible patients receive etoposide-carboplatin (EC) alone or with endostar® for 4-6 cycles (21 days for 1 cycle). In arm1 patients receive endostar® 7.5mg/m2 on day 1 to day 14, etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1. In arm2 patients receive etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1.
Primary endpoint: progress free survival (PFS).
Secondary endpoint: progress free survival at 6 months, overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR), Response duration, time to progression(TTP) and quality of life (QOL).
- Conditions
- Small Cell Lung Cancer
- Being tested
- Endostar, Etoposide-Carboplatin
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndostarDrug
Endostar® 7.5mg/m2 on day 1 to day 14
Etoposide-CarboplatinDrug
Etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1.
| Study group | Role | What they receive |
|---|---|---|
| Etoposide-Carboplatin with Endostar | Experimental | Endostar® 7.5mg/m2 on day 1 to day 14, etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1. Receives: Drug: Endostar; Drug: Etoposide-Carboplatin |
| Etoposide-Carboplatin | Active comparator | Etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1. Receives: Drug: Etoposide-Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Measured: Oct-30-2012
Secondary outcomes (7)
Progression free survival
Measured: at 6 months
Overall survival (OS)
Measured: Oct-30-2012
Objective response rate (ORR)
Measured: Oct-30-2012
Clinical benefit rate (CBR)
Measured: Oct-30-2012
Response duration
Measured: Oct-30-2012
Time to progression(TTP)
Measured: Oct-30-2012
Quality of life (QOL)
Measured: Oct-30-2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Simcere-Medgenn Bio-pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shun Lu, Dr., Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912392
- Sponsor's protocol ID
- SIM-69
- Status last verified
- Aug 2014
- First submitted
- 1 Jun 2009
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etoposide-Carboplatin (EC) Versus EC Plus Endostar in Patients With Extensive Disease Small Cell Lung Cancer (ED-SCLC): Randomized, Open Label, Placebo-controlled, Multicentre Study
- ClinicalTrials.gov ID
- NCT00912392
- Acronym / sponsor ID
- SIM-69
- Conditions
- Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Shandong Simcere-Medgenn Bio-pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 3 Jun 2009 (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.
Background:
The effect of existing treatment modalities of extensive disease small-cell lung cancer (ED-SCLC) is unsatisfactory. Progress of new strategies including more efficient therapy is wanted. Endostar® (Rh-endostatin Injection) may 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® combined with etoposide-carboplatin (EC) chemotherapy in patients with ED-SCLC seeking for more effective treatment.
Detailed description
Methods:
In this randomized, open label, placebo-controlled, multicentre trial, 120 patients are planned to be enrolled at random into 2 arms(1:1) from 10 centers between June 2009 and June 2011. The leader units are Shanghai Chest Hospital Affiliated to Shanghai Jiao-Tong University. Main eligibility criteria are histological or cytological diagnosis of ED-SCLC, with an age of 18-75 years. All eligible patients receive etoposide-carboplatin (EC) alone or with endostar® for 4-6 cycles (21 days for 1 cycle). In arm1 patients receive endostar® 7.5mg/m2 on day 1 to day 14, etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1. In arm2 patients receive etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1.
Primary endpoint: progress free survival (PFS).
Secondary endpoint: progress free survival at 6 months, overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR), Response duration, time to progression(TTP) and quality of life (QOL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etoposide-Carboplatin with Endostar | Experimental | Drug: Endostar, Drug: Etoposide-CarboplatinEndostar® 7.5mg/m2 on day 1 to day 14, etoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1. |
| Etoposide-Carboplatin | Active comparator | Drug: Etoposide-CarboplatinEtoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically diagnosed SCLC;
- Age of 18-75 years;
- Life expectancy > 3 months;
- Adequate hematologic, renal, and hepatic function;
- ECOG PS 0-2;
Key exclusion criteria (5 listed)
- Brain metastases;
- Clinically significant cardiovascular disease;
- Presence of hepatic and renal dysfunction;
- Evidence of 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 |
|---|---|---|
| EndostarEndostar® 7.5mg/m2 on day 1 to day 14 | Drug | Etoposide-Carboplatin with Endostar |
| Etoposide-CarboplatinEtoposide 60 mg/m2 on day 1 to day 5 and carboplatin AUC 5 on day 1. | Drug | Etoposide-Carboplatin, Etoposide-Carboplatin with Endostar |
Primary outcome
Progression free survival (PFS)
Time frame: Oct-30-2012
7 secondary outcomes
Progression free survival
Time frame: at 6 months
Overall survival (OS)
Time frame: Oct-30-2012
Objective response rate (ORR)
Time frame: Oct-30-2012
Clinical benefit rate (CBR)
Time frame: Oct-30-2012
Response duration
Time frame: Oct-30-2012
Time to progression(TTP)
Time frame: Oct-30-2012
Quality of life (QOL)
Time frame: Oct-30-2012
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 3 Sep 2014.
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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.
Shun Lu, Dr. principal investigator
Shanghai Chest 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 and Etoposide-Carboplatin in people with 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 5 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 3 Sep 2014. 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: Oct-30-2012). 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 3 Sep 2014.