Lung CancerPhase 2NCT00465907
Study of Weekly Paclitaxel, Carboplatin and Irinotecan to Treat Lung Cancer
A Phase 2 study testing Paclitaxel, Carboplatin and Irinotecan in people with Lung Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in Singapore.
Trial summary
Evaluate the efficacy and toxicity of the weekly combination chemotherapy of Paclitaxel, Carboplatin and Irinotecan in Stage IIIb and IV NSCLC with malignant pleural effusion Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Paclitaxel, Carboplatin and Irinotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSingapore
- Study dates
- May 2003to Feb 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological diagnosis of non-small cell lung cancer.
- Malignant pleural effusion proven by cytological examination.
- Patient must have stage IIIB or IV disease with malignant pleural effusion.
- We plan to recruit 16 patients who have smoked cigarettes of at least 20 pack per year, 16 patients who do not smoke but have been exposed to second hand smoking by living with a person who has smoked 20 pack per year cigarette in the same household and 16 patients who are non-smokers (never smoked) and no second hand smoking exposure in the same household. The accrual will be stopped once the number of patients is reached in each group.
- ECOG PS 0, 1 or 2.
- Measurable disease (in addition to malignant pleural effusion).
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- No prior chemotherapy for metastatic or recurrent disease. Patient may have surgery or radiation or combined chemoradiation, or neoadjuvant chemotherapy at primary diagnosis. This kind of chemotherapy will not be counted as patient has had prior chemotherapy for metastatic or recurrent NSCLC.
- WBC > 3500/uL and ANC > 2,000/uL, platelet > 100,000/uL AST/ALT < 3 X UNL, bilirubin < 1.5 mg/dL ( or < 35 uM), creatinine < 1.5 mg/dL (or < 125uM for men and 90uM for women).
- Age > 18
- No history of congestive heart failure, myocardial infarction or life-threatening arrhythmia (such as ventricular tachycardia, supraventricular tachycardia, brachycardia < 40/min or atrial fibrillation or flutter with ventricular rate > 150/min) within 6 months of entry.
- Signed informed consent
- Negative mammogram and ovaries examination by CT scans and no history of breast cancer or ovarian cancer in female patients.
- Negative pregnancy test in female menstruating patient within one week of starting chemotherapy and use of effective contraceptive methods during study.
- Patients with brain metastasis will be eligible provided their neurological abnormality is stable or improved after whole brain radiation, stereostatic radiosurgery or gamma knife treatment and/or dexamethasone for 3 weeks and patients fulfil all other eligibility criteria.
Who cannot join
- ECOG performance status 3 or worse.
- Any prior chemotherapy regimen for metastatic or recurrent diseases.
- No measurable disease, even after drainage of pleural effusion.
- ANC < 1,999/uL or Bilirubin > 1.5 mg/dL (or > 35uM)
- Plt < 100,000/uL or
- ALT/AST > 3 x UNL
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- Creatinine > 1.5mg/dL (or > 125uM)
- Patient has history of congestive heart failure, myocardial infarction or life-threatening arrhythmia (such as ventricular tachycardia, supraventricular tachycardia, atrial fibrillation/flutter with ventricular rate > 150/min or bradycardia < 40/min) within 6 months before entry.
- Prior history of breast cancer or ovarian cancer in female patients or any cancer except cured cervical carcinoma in-situ or skin cancer.
- Fasting blood sugar > 200 mg/dL (> 14uM) except in patients on dexamethasone for brain metastases.
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Johns Hopkins Singapore International Medical Center
Singapore, 308433
About this study
Official title: Phase II Study of Weekly Paclitaxel, Carboplatin and Irinotecan in Patients With Advanced Non-Small Cell Lung Cancer Nad Malignant Pleural Effusion
Evaluate the efficacy and toxicity of the weekly combination chemotherapy of Paclitaxel, Carboplatin and Irinotecan in Stage IIIb and IV NSCLC with malignant pleural effusion
Read the detailed description
Lung cancer is the leading cancer death in many countries of the world including Singapore. Non-small cell lung cancer (NSCLC) consists of 80-85% of lung cancers, and is a major health problem. The main etiology of lung cancer is well recognized and established to be cigarette smoking which accounts for up to 80% of the cases in the western countries. Due to success of anti-smoking campaign, we anticipate to see less smoking related lung cancer and more non-smoking related lung cancer which is rising rapidly. For eg, currently in Singapore, smoking only accounts for 50-60% of all lung cancers, this is particularly true in female patients, as smoking occured in 30-40% of female lung cancer patients only.
It is unclear if there is any significant difference in the fundamental biology between smoking and non-smoking related lung cancers, particularly in areas of natural course of disease, genetic changes of tumor cells, clinical presentation, response to treatment or survival. These are potential aspects for further investigation.
- Conditions
- Lung Cancer
- Being tested
- Paclitaxel, Carboplatin and Irinotecan
- Keywords
- lung cancer with malignant pleural effusion
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel, Carboplatin and IrinotecanDrug
Paclitaxel-60mg/m2 weekly for 3 weeks Carboplatin - AUC 1.5, weekly for 3 weeks Irinotecan - 60mg/m2, weekly for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel, Carboplatin and Irinotecan | Experimental | Study of Weekly Paclitaxel, Carboplatin and Irinotecan in patients with Non-Small Cell Lung Carcinoma Receives: Drug: Paclitaxel, Carboplatin and Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy and toxicity of the weekly combination chemotherapy of paclitaxel, carboplatin and irinotecan in Stage IIIB and IV NSCLC patients with malignant pleural effusion
Measured: 3 years
Secondary outcomes (2)
To determine the pharmacokinetics and pharmacodynamics of paclitaxel and irinotecan in the blood and pleural effusion.
Measured: 3 years
To compare the gene expression pattern of non-small cell lung cancer from cigarette-smoking, passive smoking and no tobacco exposure patients before and after chemotherapy.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2007 (estimated)
- Study startMay 2003
- Primary completionMar 2008
- Study completionFeb 2014
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- 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
- 7 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alex Chang, MD, Principal investigator, Johns Hopkins Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465907
- Sponsor's protocol ID
- JS 0312
- Other IDs
- NA_00037282
- Status last verified
- Feb 2019
- First submitted
- 23 Apr 2007
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Weekly Paclitaxel, Carboplatin and Irinotecan in Patients With Advanced Non-Small Cell Lung Cancer Nad Malignant Pleural Effusion
- ClinicalTrials.gov ID
- NCT00465907
- Acronym / sponsor ID
- JS 0312
- Conditions
- Lung Cancer
- Keywords
- lung cancer with malignant pleural effusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- May 2003
- Primary completion
- Mar 2008 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 25 Apr 2007 (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.
Evaluate the efficacy and toxicity of the weekly combination chemotherapy of Paclitaxel, Carboplatin and Irinotecan in Stage IIIb and IV NSCLC with malignant pleural effusion
Detailed description
Lung cancer is the leading cancer death in many countries of the world including Singapore. Non-small cell lung cancer (NSCLC) consists of 80-85% of lung cancers, and is a major health problem. The main etiology of lung cancer is well recognized and established to be cigarette smoking which accounts for up to 80% of the cases in the western countries. Due to success of anti-smoking campaign, we anticipate to see less smoking related lung cancer and more non-smoking related lung cancer which is rising rapidly. For eg, currently in Singapore, smoking only accounts for 50-60% of all lung cancers, this is particularly true in female patients, as smoking occured in 30-40% of female lung cancer patients only.
It is unclear if there is any significant difference in the fundamental biology between smoking and non-smoking related lung cancers, particularly in areas of natural course of disease, genetic changes of tumor cells, clinical presentation, response to treatment or survival. These are potential aspects for further investigation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel, Carboplatin and Irinotecan | Experimental | Drug: Paclitaxel, Carboplatin and IrinotecanStudy of Weekly Paclitaxel, Carboplatin and Irinotecan in patients with Non-Small Cell Lung Carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histological or cytological diagnosis of non-small cell lung cancer.
- Malignant pleural effusion proven by cytological examination.
- Patient must have stage IIIB or IV disease with malignant pleural effusion.
- We plan to recruit 16 patients who have smoked cigarettes of at least 20 pack per year, 16 patients who do not smoke but have been exposed to second hand smoking by living with a person who has smoked 20 pack per year cigarette in the same household and 16 patients who are non-smokers (never smoked) and no second hand smoking exposure in the same household. The accrual will be stopped once the number of patients is reached in each group.
- ECOG PS 0, 1 or 2.
Key exclusion criteria (10 listed)
- ECOG performance status 3 or worse.
- Any prior chemotherapy regimen for metastatic or recurrent diseases.
- No measurable disease, even after drainage of pleural effusion.
- ANC < 1,999/uL or Bilirubin > 1.5 mg/dL (or > 35uM)
- Plt < 100,000/uL or
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 |
|---|---|---|
| Paclitaxel, Carboplatin and IrinotecanPaclitaxel-60mg/m2 weekly for 3 weeks Carboplatin - AUC 1.5, weekly for 3 weeks Irinotecan - 60mg/m2, weekly for 3 weeks | Drug | Paclitaxel, Carboplatin and Irinotecan |
Primary outcome
To evaluate the efficacy and toxicity of the weekly combination chemotherapy of paclitaxel, carboplatin and irinotecan in Stage IIIB and IV NSCLC patients with malignant pleural effusion
Time frame: 3 years
2 secondary outcomes
To determine the pharmacokinetics and pharmacodynamics of paclitaxel and irinotecan in the blood and pleural effusion.
Time frame: 3 years
To compare the gene expression pattern of non-small cell lung cancer from cigarette-smoking, passive smoking and no tobacco exposure patients before and after chemotherapy.
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
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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.
Alex Chang, MD principal investigator
Johns Hopkins Singapore
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 Paclitaxel, Carboplatin and Irinotecan in people with Lung Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in Singapore.
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 14 inclusion and 10 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: stopped early, as of the sponsor's last update on 11 Feb 2019. 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 Singapore. 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 was stopped early (reason given: Low accrual). Results are not available in the source record.
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?
To evaluate the efficacy and toxicity of the weekly combination chemotherapy of paclitaxel, carboplatin and irinotecan in Stage IIIB and IV NSCLC patients with malignant pleural effusion (time frame: 3 years). 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 11 Feb 2019.