Non-Small Cell Lung CancerPhase 3NCT02058433
Safety Study of Individual Paclitaxel Dose Adjustment Based on Pharmacokinetics in Non-Small Cell Lung Cancer (NSCLC)
A Phase 3 study testing dosage of paclitaxel in people with Non-Small Cell Lung Cancer, run by Caicun Zhou at 1 site in China.
Trial summary
Platinum-based doublets including paclitaxel, gemcitabine, or docetaxel are standard 1st regimens in Non-Small Cell Lung Cancer(NSCLC). The traditional method of individualizing cytotoxic drug dose is by using body surface area(BSA), which is not correlated with the ability of an individual to metabolize or excrete… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- dosage of paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Dec 2016
- Phase
- Phase 3
- 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
- For inclusion in the study treatment period patients must fulfil all of the following criteria:
- Provision of informed consent.
- Male or female aged 18 years and over.
- Histologically or cytologically confirmed non-small cell lung carcinoma.
- Locally advanced Stage not amenable to local therapy (e.g. pleural effusion) or metastatic disease.
- No prior chemotherapy, biological (including targeted therapies such as Epidermal Growth Factor Receptor(EGFR) and Vascular Epidermal Growth Factor (VEGF) inhibitors) or immunological therapy. Patients who are willing to accept with paclitaxel and carboplatin as adjuvant chemotherapy will be eligible.
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- World Health Organization (WHO) performance status (PS) of 0 to 2.
- Females of child-bearing potential must have negative serum pregnancy test. Sexually active males and females (of childbearing potential) willing to practice contraception during the study.
- Laboratory values within the range, as defined below, within two weeks of randomization:
- Absolute neutrophils count(ANC)≥2.0×109/L
- Platelets≥100×109/L
- Serum bilirubin≤2×ULN; Aspartate transaminase(AST) and alanine tansaminase (ALT) ≤2.5×ULN(≤5×ULN if liver metastases)
- Creatinine clearance≥60ml/min
- Measurable disease according to Response Evaluation Criteria in Solid Tumors(RECIST) criteria with at least one measurable lesion not previously irradiated.
- Life expectancy ≥12 weeks.
Who cannot join
- Any of the following is regarded as a criterion for exclusion from the study:
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease).
- Newly diagnosed Central Nervous System (CNS) metastases that have not yet been definitively treated with surgery and/or radiation.
- Known severe hypersensitivity to carboplatin, paclitaxel or any of the excipients of these products.Known severe hypersensitivity to pre-medications required for treatment with carboplatin / paclitaxel doublet chemotherapy.
- Prior treatment with paclitaxel.
- Current treatment with target drug and biological therapy.
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- Pregnant or lactating woman.
- Prior chemotherapy, biological (including targeted therapies such as Epidermal Growth Factor Receptor(EGFR) and Vascular Epidermal Growth Factor (VEGF) inhibitors) or immunological therapy were received even if treatment was not paclitaxel and was completed in 4 weeks before day1 of study treatment.
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
- Life expectancy of less than 12 weeks.
- Unable to tolerate carboplatin / paclitaxel doublet chemotherapy, as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Medical Department, Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Jie Zhang, MD, 13501878890, zhangjie2172@163.com
Caicun Zhou, PH.D
About this study
Official title: Phase 3, Randomized, Open-label Study of the Safety of Individual Paclitaxel Dose Adjustment Based on Pharmacokinetic Follow up Versus Conventional Dosage in First-line Treatment in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Platinum-based doublets including paclitaxel, gemcitabine, or docetaxel are standard 1st regimens in Non-Small Cell Lung Cancer(NSCLC). The traditional method of individualizing cytotoxic drug dose is by using body surface area(BSA), which is not correlated with the ability of an individual to metabolize or excrete cytotoxic drugs, because it is not related to liver function and is poorly correlated with glomerular filtration rate, and does not seem to be a determinant of toxicity. Pharmacokinetic parameters such as area under the curve have been shown to correlate with toxicity. The advantages of using a fixed dose of antineoplastic agents for all of the patients are obvious. Pharmacokinetically guided treatment would avoid severe adverse effects, which has not been sufficiently investigated in advanced NSCLC.First, the investigators monitor the blood concentrations of paclitaxel and neutropenia blood toxicity after chemotherapy with paclitaxel and carboplatin in patients of NSCLC and verify suitable paclitaxel therapeutic window for Chinese patients. Then the investigators compare safety and efficacy between individual paclitaxel dose adjustment based on the therapeutic window compared with conventional dosage.
Read the detailed description
Primary end point: Common Terminology Criteria for Adverse Events(CTCAE) grade 4.
Secondary end point:Objective Response Rate(ORR),Progression Free Survival(PFS),Overall Survival(OS),Quality Of Life(QOL) etc.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- dosage of paclitaxel
- Keywords
- Chemotherapy, Individual Paclitaxel dose, pharmacokinetics
- 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.
dosage of paclitaxelOther
Based on pharmacokinetics. Observe the toxicity in an individual patient after a fixed Paclitaxel dose depending on BSA and then the dosage of Paclitaxel is adjusted depending on pharmacokinetics follow up to avoid excess toxicity in subsequent cycles.
dosage of paclitaxelOther
Based on body surface area. The dosage of Paclitaxel is based on the BSA of the patient. Paclitaxel/carboplatin up to 4 cycles or disease progression or intolerable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| pharmacokinetics group | Experimental | Based on pharmacokinetics. Observe safety and efficacy. In first cycle a fixed Paclitaxel dose depends on BSA. In subsequent cycles the dosage of Paclitaxel will be adjusted depending on pharmacokinetics follow up . Receives: Other: dosage of paclitaxel |
| Body surface area(BSA) group | Active comparator | Based on body surface area. The dosage of Paclitaxel is based on the BSA of the patient. Paclitaxel/carboplatin up to 4 cycles or disease progression or intolerable toxicity. Receives: Other: dosage of paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
CTCAE grade 4 of the blood marrow
Record the number of CTCAE grade 4 of the blood marrow such as Leukocytes, Neutrophils,Platelets and Hemoglobin in two treatment groups since the initiation of chemotherapy
Measured: 24 months
Secondary outcomes (4)
Objective response rate
The objective tumour response rate will be calculated as the percentage of evaluable patients with complete response (CR) and partial response (PR).
Measured: Tumor assessment 6-8 weeks after the initiation of chemotherapy
Progression free survival
Progression Free Survival (PFS) is defined as the time from randomization to the first documentation of objective disease progression (PD) or death from any cause.
Measured: 12 months
Overall survival
Overall survival(OS) is defined as the interval between the date of randomization and the date of patient death due to any cause, or the last date the patient was known to be alive.
Measured: 24 months
Quality of life
Data on QoL will be assessed using the Functional Assessment of Cancer Therapy - Lung (FACT-L) for every patients.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Caicun Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Caicun Zhou, Tongji University
- Investigators
- Caicun Zhou, Ph.D, Principal investigator, Tongji University Affiliated Shanghai Pulmonary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058433
- Sponsor's protocol ID
- SPAP
- Status last verified
- Feb 2014
- First submitted
- 27 Jan 2014
- Last updated
- 10 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang J, Zhou F, Qi H, Ni H, Hu Q, Zhou C, Li Y, Baburina I, Courtney J, Salamone SJ. Randomized study of individualized pharmacokinetically-guided dosing of paclitaxel compared with body-surface area dosing in Chinese patients with advanced non-small cell lung cancer. Br J Clin Pharmacol. 2019 Oct;85(10):2292-2301. doi: 10.1111/bcp.13982. Epub 2019 Jun 14.
PubMed 31077432
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Randomized, Open-label Study of the Safety of Individual Paclitaxel Dose Adjustment Based on Pharmacokinetic Follow up Versus Conventional Dosage in First-line Treatment in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT02058433
- Acronym / sponsor ID
- SPAP
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Chemotherapy, Individual Paclitaxel dose, pharmacokinetics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Caicun ZhouUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 10 Feb 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.
Platinum-based doublets including paclitaxel, gemcitabine, or docetaxel are standard 1st regimens in Non-Small Cell Lung Cancer(NSCLC). The traditional method of individualizing cytotoxic drug dose is by using body surface area(BSA), which is not correlated with the ability of an individual to metabolize or excrete cytotoxic drugs, because it is not related to liver function and is poorly correlated with glomerular filtration rate, and does not seem to be a determinant of toxicity. Pharmacokinetic parameters such as area under the curve have been shown to correlate with toxicity. The advantages of using a fixed dose of antineoplastic agents for all of the patients are obvious. Pharmacokinetically guided treatment would avoid severe adverse effects, which has not been sufficiently investigated in advanced NSCLC.First, the investigators monitor the blood concentrations of paclitaxel and neutropenia blood toxicity after chemotherapy with paclitaxel and carboplatin in patients of NSCLC and verify suitable paclitaxel therapeutic window for Chinese patients. Then the investigators compare safety and efficacy between individual paclitaxel dose adjustment based on the therapeutic window compared with conventional dosage.
Detailed description
Primary end point: Common Terminology Criteria for Adverse Events(CTCAE) grade 4.
Secondary end point:Objective Response Rate(ORR),Progression Free Survival(PFS),Overall Survival(OS),Quality Of Life(QOL) etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pharmacokinetics group | Experimental | Other: dosage of paclitaxelBased on pharmacokinetics. Observe safety and efficacy. In first cycle a fixed Paclitaxel dose depends on BSA. In subsequent cycles the dosage of Paclitaxel will be adjusted depending on pharmacokinetics follow up . |
| Body surface area(BSA) group | Active comparator | Other: dosage of paclitaxelBased on body surface area. The dosage of Paclitaxel is based on the BSA of the patient. Paclitaxel/carboplatin up to 4 cycles or disease progression or intolerable toxicity. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- For inclusion in the study treatment period patients must fulfil all of the following criteria:
- Provision of informed consent.
- Male or female aged 18 years and over.
- Histologically or cytologically confirmed non-small cell lung carcinoma.
- Locally advanced Stage not amenable to local therapy (e.g. pleural effusion) or metastatic disease.
Key exclusion criteria (11 listed)
- As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease).
- Newly diagnosed Central Nervous System (CNS) metastases that have not yet been definitively treated with surgery and/or radiation.
- Known severe hypersensitivity to carboplatin, paclitaxel or any of the excipients of these products.Known severe hypersensitivity to pre-medications required for treatment with carboplatin / paclitaxel doublet chemotherapy.
- Prior treatment with paclitaxel.
- Current treatment with target drug and biological therapy.
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 |
|---|---|---|
| dosage of paclitaxelBased on pharmacokinetics. Observe the toxicity in an individual patient after a fixed Paclitaxel dose depending on BSA and then the dosage of Paclitaxel is adjusted depending on pharmacokinetics follow up to avoid excess toxicity in subsequent cycles. | Other | pharmacokinetics group |
| dosage of paclitaxelBased on body surface area. The dosage of Paclitaxel is based on the BSA of the patient. Paclitaxel/carboplatin up to 4 cycles or disease progression or intolerable toxicity. | Other | Body surface area(BSA) group |
Primary outcome
CTCAE grade 4 of the blood marrow
Time frame: 24 months
Record the number of CTCAE grade 4 of the blood marrow such as Leukocytes, Neutrophils,Platelets and Hemoglobin in two treatment groups since the initiation of chemotherapy
4 secondary outcomes
Objective response rate
Time frame: Tumor assessment 6-8 weeks after the initiation of chemotherapy
Progression free survival
Time frame: 12 months
Overall survival
Time frame: 24 months
Quality of life
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2014.
- Derived from this study: PubMed 31077432Zhang J, Zhou F, Qi H, Ni H, Hu Q, Zhou C, Li Y, Baburina I, Courtney J, Salamone SJ. Randomized study of individualized pharmacokinetically-guided dosing of paclitaxel compared with body-surface area dosing in Chinese patients with advanced non-small cell lung cancer. Br J Clin Pharmacol. 2019 Oct;85(10):2292-2301. doi: 10.1111/bcp.13982. Epub 2019 Jun 14.
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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.
Caicun Zhou, Ph.D principal investigator
Tongji University Affiliated Shanghai Pulmonary Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dosage of paclitaxel in people with Non-Small Cell Lung Cancer, run by Caicun Zhou 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 15 inclusion and 11 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 10 Feb 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Jie Zhang, MD (13501878890, zhangjie2172@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CTCAE grade 4 of the blood marrow (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02058433, which also lists 1 linked publication.
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 10 Feb 2014.