Safety Study of Individual Paclitaxel Dose Adjustment Based on Pharmacokinetics in Non-Small Cell Lung Cancer (NSCLC)
2014年2月6日 更新者：Caicun Zhou
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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (予想される)
140
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Shanghai
-
Shanghai、Shanghai、中国、200433
- 募集
- Medical Department, Shanghai Pulmonary Hospital
-
副調査官：
- Jie Zhang, MD
-
副調査官：
- Huiwei Qi, MD
-
副調査官：
- Fengying Wu, MD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～75年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
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.
- 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.
Exclusion Criteria:
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.
- 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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：pharmacokinetics group
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 .
|
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.
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.
|
|
アクティブコンパレータ：Body surface area(BSA) group
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.
|
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.
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
CTCAE grade 4 of the blood marrow
時間枠：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
|
24 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Objective response rate
時間枠：Tumor assessment 6-8 weeks after the initiation of chemotherapy
|
The objective tumour response rate will be calculated as the percentage of evaluable patients with complete response (CR) and partial response (PR).
|
Tumor assessment 6-8 weeks after the initiation of chemotherapy
|
|
Progression free survival
時間枠：12 months
|
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.
|
12 months
|
|
Overall survival
時間枠：24 months
|
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.
|
24 months
|
|
Quality of life
時間枠：24 months
|
Data on QoL will be assessed using the Functional Assessment of Cancer Therapy - Lung (FACT-L) for every patients.
|
24 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Caicun Zhou, Ph.D、Tongji University Affiliated Shanghai Pulmonary Hospital
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2014年1月1日
一次修了 (予想される)
2015年12月1日
研究の完了 (予想される)
2016年12月1日
試験登録日
最初に提出
2014年1月27日
QC基準を満たした最初の提出物
2014年2月6日
最初の投稿 (見積もり)
2014年2月10日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年2月10日
QC基準を満たした最後の更新が送信されました
2014年2月6日
最終確認日
2014年2月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- SPAP
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。