Small Cell Lung CancerPhase 2NCT02171325
Study of Different Doses of Irinotecan and Cisplatin for First-line Extensive-stage Small-cell Lung Cancer Treatment
A Phase 2 study testing irinotecan in people with Small Cell Lung Cancer, run by Guangdong Association of Clinical Trials at 1 site in China.
Trial summary
The purpose of this study is to identify the appropriate dose of irinotecan by dose escalation(dose climbing) test. The study would provide rationale for regimen decision in a future phase III clinical trial, in which irinotecan combined with cisplatin(IP) will be selected as therapeutic drugs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- irinotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Jun 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years, male and female
- Histologically or cytologically confirmed extensive stage .small cell lung cancer(SCLC )（except metastases only as pleural effusion）
- No prior chemotherapy
- Metastatic lesion had been treated more than 14 days by palliative radiation therapy or surgery
- With measurable tumor lesions (Non-irradiated parts),(RECIST 1.1: Without radiotherapy ,the longest diameter is more than 10mm by CT or MRI ,except that lymph nodes need short diameter need more then 15mm, and the lesions can be accurately evaluated repeatedly measurable)
- Eastern Cooperative Oncology Group(ECOG) Performance Status 0-1
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- Expected survival ≥ 3months
- Marrow,kidney, liver,heart and lung are well -functioning,and absolute count of
- absolute neutrophil coun(ANC) ≥ 2.0 × 109 / L
- blood platelet(PLT) ≥ 100 × 109 / L
- Hb≥ 90g / L
- conjugative bilirubin(CB)≤ upper limit of normal(ULN) × 1.5
- Aspartate transaminase(AST )(glutamic oxalacetic transaminase,GOT): ≤ upper limit of normal(ULN )× 2.5
- Alanine aminotransferase(ALT)(Glutamate Pyruvate Transaminase,GPT): ≤ ULN × 2.5
- Serum creatinine: ≤ ULN or calculated creatinine clearance≥ 60 ml / min
- (PT INR) ≤ ULN × 1.5
- ECG: no abnormalities in need of treatment
- No pregnancy or no pregnancy demand at the end of the study within six months
- Must provide written informed consent.
Who cannot join
- Patient have platinum compounds allergy history
- Patient with active ulcer disease or chronic enteritis patients
- Primary lesion(s) has (have) been treated by Surgery or radiation
- Patient had received Immune drugs treatment for anti-lung cancer indications or anti-cancer Chinese traditional medicine treatment within two weeks
- Patients with interstitial pneumonia or pulmonary fibrosis
- Brain metastasis requiring treatment
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- Patient with bronchus or bronchial stenosis or blockage and superior vena cava syndrome caused by serious invasion
- Patients with severe infections, severe abnormal secretion of (Anti Diuretic Hormone,ADH) syndrome, poorly controlled diabetes, severe complications requiring treatment vena cava syndrome
- Severe cardiovascular disease: hypertension that medical treatment can not be controlled , unstable angina, myocardial infarction within the last June a history of congestive heart failure> 3 (NYHA) and severe arrhythmia
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jilin cancer hospital
Changchun, Jilin, 130000
ying cheng, doctor, 86-43185871902, jl.cheng@163.com
About this study
Official title: A Phase Ⅱ Study of Different Doses of Irinotecan and Cisplatin for First-line Extensive-stage Small-cell Lung Cancer Treatment
The purpose of this study is to identify the appropriate dose of irinotecan by dose escalation(dose climbing) test. The study would provide rationale for regimen decision in a future phase III clinical trial, in which irinotecan combined with cisplatin(IP) will be selected as therapeutic drugs.
Read the detailed description
To determine the Maximum Tolerated Dose (MTD) and Limiting Toxicity (DLTs) of irinotecan in patients with extensive stage small cell lung cancer treated with irinotecan plus cisplatin
- Conditions
- Small Cell Lung Cancer
- Being tested
- irinotecan
- Keywords
- irinotecan, Small Cell Lung Cancer
- 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.
irinotecanDrug
60 mg/m2、65mg/m2、70mg/m2、75mg/m2、80mg/m2、85mg/m2、90mg/m2、95mg/m2、100mg/m2
| Study group | Role | What they receive |
|---|---|---|
| irinotecan | Experimental | irinotecan； 60 mg/m2、65mg/m2、70mg/m2、75mg/m2、80mg/m2、85mg/m2、90mg/m2、95mg/m2、100mg/m2 Receives: Drug: irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limiting Toxicity (DLT )in the irinotecan
Measured: up to 18 weeks
Secondary outcomes (1)
Maximum Tolerated Dose(MTD)in the irinotecan
Measured: up to 18weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Association of Clinical Trials
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ying cheng, doctor, Principal investigator, Jilin Provincial Tumor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171325
- Sponsor's protocol ID
- CTONG1402
- Status last verified
- Feb 2021
- First submitted
- 16 Jun 2014
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅱ Study of Different Doses of Irinotecan and Cisplatin for First-line Extensive-stage Small-cell Lung Cancer Treatment
- ClinicalTrials.gov ID
- NCT02171325
- Acronym / sponsor ID
- CTONG1402
- Conditions
- Small Cell Lung Cancer
- Keywords
- irinotecan, Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Guangdong Association of Clinical TrialsUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 24 Jun 2014 (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 identify the appropriate dose of irinotecan by dose escalation(dose climbing) test. The study would provide rationale for regimen decision in a future phase III clinical trial, in which irinotecan combined with cisplatin(IP) will be selected as therapeutic drugs.
Detailed description
To determine the Maximum Tolerated Dose (MTD) and Limiting Toxicity (DLTs) of irinotecan in patients with extensive stage small cell lung cancer treated with irinotecan plus cisplatin
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| irinotecan | Experimental | Drug: irinotecanirinotecan； 60 mg/m2、65mg/m2、70mg/m2、75mg/m2、80mg/m2、85mg/m2、90mg/m2、95mg/m2、100mg/m2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age 18 to 65 years, male and female
- Histologically or cytologically confirmed extensive stage .small cell lung cancer(SCLC )（except metastases only as pleural effusion）
- No prior chemotherapy
- Metastatic lesion had been treated more than 14 days by palliative radiation therapy or surgery
- With measurable tumor lesions (Non-irradiated parts),(RECIST 1.1: Without radiotherapy ,the longest diameter is more than 10mm by CT or MRI ,except that lymph nodes need short diameter need more then 15mm, and the lesions can be accurately evaluated repeatedly measurable)
Key exclusion criteria (9 listed)
- Patient have platinum compounds allergy history
- Patient with active ulcer disease or chronic enteritis patients
- Primary lesion(s) has (have) been treated by Surgery or radiation
- Patient had received Immune drugs treatment for anti-lung cancer indications or anti-cancer Chinese traditional medicine treatment within two weeks
- Patients with interstitial pneumonia or pulmonary fibrosis
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 |
|---|---|---|
| irinotecan60 mg/m2、65mg/m2、70mg/m2、75mg/m2、80mg/m2、85mg/m2、90mg/m2、95mg/m2、100mg/m2 | Drug | irinotecan |
Primary outcome
Limiting Toxicity (DLT )in the irinotecan
Time frame: up to 18 weeks
1 secondary outcome
Maximum Tolerated Dose(MTD)in the irinotecan
Time frame: up to 18weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Individual participant dataSharing planned: No
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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.
ying cheng, doctor principal investigator
Jilin Provincial Tumor 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 irinotecan in people with Small Cell Lung Cancer, run by Guangdong Association of Clinical Trials 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 19 inclusion and 9 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 3 Feb 2021. 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 ying cheng, doctor (86-43185871902, jl.cheng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limiting Toxicity (DLT )in the irinotecan (time frame: up to 18 weeks). 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 Feb 2021.