Proteomic Profiling in Predicting Response in Patients Receiving Erlotinib for Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
2017年5月12日 更新者：Leora Horn, MD、Vanderbilt-Ingram Cancer Center
A Feasibility Study Investigating Translational Science in Chemotherapy-Naive Patients With Stage IIIb or IV Non-Small Cell Lung Cancer (NSCLC) Treated With the EGFR-TKI, Erlotinib
RATIONALE: Studying samples of tumor tissue, blood, and urine in the laboratory from patients receiving erlotinib may help doctors predict how patients will respond to treatment.
PURPOSE: The phase II trial is studying proteomic profiling to see how well it predicts response in patients receiving erlotinib for stage IIIB, stage IV, or recurrent non-small cell lung cancer.
調査の概要
状態
完了
条件
詳細な説明
OBJECTIVES:
Primary
- To define a pre-treatment tumor proteomic profile that predicts response, stable disease, or progressive disease in patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer treated with erlotinib hydrochloride.
Secondary
- To test and refine a pre-treatment serum proteomic expression pattern that predicts response to erlotinib hydrochloride and/or carboplatin and paclitaxel after failing treatment with erlotinib hydrochloride.
- To test and refine tumor proteomic profiles that predict response to carboplatin and paclitaxel after failing treatment with erlotinib hydrochloride.
- To analyze individual and pattern(s) of erlotinib hydrochloride-induced genomic and proteomic biomarker changes in relation to response or non-response to treatment.
- To correlate the efficacy and toxicity of erlotinib hydrochloride with expression of EGFR, EGFR pathway, ErbB family, and other related biomarkers.
- To determine a set of biomarkers to be evaluated in tumor tissue or surrogate tissues prior to treatment with erlotinib hydrochloride to enable patient selection for therapy.
- To estimate response rate and progression-free and overall survival of patients treated with erlotinib hydrochloride as initial therapy.
- To characterize the safety profile of erlotinib hydrochloride in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib hydrochloride once daily until disease progression.
At the time of disease progression, patients receive standard chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 15-30 minutes on day 1. Patients with non-squamous cell non-small cell lung cancer also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses.
Tumor tissue, plasma, serum, and urine samples are collected at baseline for proteomics analysis.
After the completion of study treatment, patients are followed every 8 weeks.
研究の種類
介入
入学 (実際)
116
段階
- フェーズ2
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
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Florida
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Gainesville、Florida、アメリカ、32610-0232
- University of Florida Shands Cancer Center
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Georgia
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Atlanta、Georgia、アメリカ、30308
- Emory University
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Michigan
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Ann Arbor、Michigan、アメリカ、48109-0942
- University of Michigan Comprehensive Cancer Center
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Tennessee
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Nashville、Tennessee、アメリカ、37232-6838
- Vanderbilt-Ingram Cancer Center
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Nashville、Tennessee、アメリカ、37064
- Vanderbilt-Ingram Cancer Center - Cool Springs
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Nashville、Tennessee、アメリカ、37064
- Vanderbilt-Ingram Cancer Center at Franklin
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Texas
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Houston、Texas、アメリカ、77030-4009
- M. D. Anderson Cancer Center at University of Texas
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-
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～120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
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following criteria:
- Stage IIIB (with pleural effusion) or stage IV disease
- Recurrent disease after prior surgery
- Measurable or evaluable disease is desirable but not required
No untreated symptomatic brain metastases
- Patients who are neurologically unstable despite radiotherapy for the brain metastases are not eligible
- No requirement for steroids to control neurological symptoms
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- ANC ≥ 1,500/mm³
- Hemoglobin ≥ 9 g/dL
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 2.0 mg/dL
- Total bilirubin ≤ 1.5 mg/dL
- Normal hemostasis by history
- PT/PTT within 0.5 seconds of normal range
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Willing to undergo biopsy procedures
- No known severe hypersensitivity to erlotinib hydrochloride or any of the excipients of this product
- No other concurrent malignancies or malignancies diagnosed within the past 5 years, except basal cell carcinoma or cervical cancer in situ
No significant cardiac disease, including any of the following:
- NYHA class III or IV heart disease
- Uncontrolled dysrhythmia
- Myocardial infarction within the past 6 months
No evidence of clinically active interstitial lung disease
- Chronic stable radiographic changes that are asymptomatic allowed
- No evidence of any other severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
- No evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial
No uncontrolled hypertension
- Blood pressure must be ≤ 150/90 mmHg on a stable antihypertensive regimen
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 6 months since prior adjuvant chemotherapy
- No unresolved chronic toxicity > CTC grade 2 from prior anticancer therapy (except alopecia)
- More than 30 days since prior non-approved or investigational drugs
- No prior chemotherapy for advanced NSCLC
- No concurrent phenytoin, carbamazepine, rifampin, barbiturates, or St. John's wort
- No concurrent administration of other drugs known to inhibit EGFR
- No other concurrent anti-neoplastic or anti-tumor agents, including chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy
- No other concurrent investigational agents
- Concurrent cardioprotective doses of aspirin, as recommended by the physician, for cardiovascular disease allowed
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：なし
- 介入モデル：単一グループの割り当て
- 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：Treatment
Erlotinib followed by paclitaxel + carboplatin (+ bevacizumab in non-squamous) at the time disease progression.
|
血液および組織の採取。
15 mg/m2 given through a vein for every 3 weeks
AUC = 6 given through a vein on day 1 of each cycle.
150 mg taken by mouth daily
200 mg/m2 given through a vein on day 1 of each cycle.
Blood and tissue collection.
Blood and tissue collection.
Blood and tissue collection.
|
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 |
時間枠 |
|---|---|
|
Pre-treatment Tumor Proteomic Profile as a Predictor of Response, Stable Disease, or Progressive Disease
時間枠：End of treatment date
|
End of treatment date
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pre-treatment Serum Proteomic Expression Pattern as a Predictor of Response to Erlotinib Hydrochloride and/or Carboplatin and Paclitaxel After Failing Treatment With Erlotinib Hydrochloride
時間枠：End of treatment date
|
End of treatment date
|
|
|
Tumor Proteomic Profiles as Predictors of Response to Carboplatin and Paclitaxel After Failing Treatment With Erlotinib Hydrochloride
時間枠：End of treatment date
|
End of treatment date
|
|
|
Analysis of Individual and Pattern(s) of Erlotinib Hydrochloride-induced Genomic and Proteomic Biomarker Changes in Relation to Response or Non-response to Treatment
時間枠：End of treatment date
|
End of treatment date
|
End of treatment date
|
|
Correlation of the Efficacy and Toxicity of Erlotinib Hydrochloride With Expression of EGFR, EGFR Pathway, ErbB Family, and Other Related Biomarkers
時間枠：End of treatment date
|
End of treatment date
|
|
|
Determination of a Set of Biomarkers to be Evaluated in Tumor Tissue or Surrogate Tissues Prior to Treatment With Erlotinib Hydrochloride to Enable Patient Selection for Therapy
時間枠：End of treatment date
|
End of treatment date
|
|
|
Response Rate for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC
時間枠：Through study completion, an average of 1 year
|
Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD.
The response rate is calculated as the percentage of PR+CR among patients assessed for response.
|
Through study completion, an average of 1 year
|
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Progression-free Survival (PFS) for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC
時間枠：Through study completion, an average of 1 year
|
PFS is defined as the time from on erlotinib treatment date to progression or death (whichever comes first) before cross-over to PC or PC+B.
For those did not progressed nor died, they were censored at the last follow up (either the off erlotinib treatment date or lost follow up date).
The median survival time and 95% confidence interval were estimated using Kaplan-meier method.
|
Through study completion, an average of 1 year
|
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Number of Patients With Worst-grade Toxicities Per Grade
時間枠：Through study completion, an average of 1 year
|
The intensity of the AE will be graded according to the Common Toxicity Criteria (CTC) of the (US) National Cancer Institute (NCI) - Cancer Therapy Evaluation Program (CTEP) [version 3.0 of December 2003] (Appendix B). Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE |
Through study completion, an average of 1 year
|
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Overall Survival for Erlotinib Initial Therapy in Chemotherapy-naïve Patients With Advanced NSCLC
時間枠：Through study completion, an average of 1 year
|
The overall survival time is defined as the time from on treatment to death.
Patients were censored of they were alive at the last follow up date.
The median survival time and its confidence interval were estimated using Kaplan-meier method.
|
Through study completion, an average of 1 year
|
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。
捜査官
- スタディチェア：David Carbone, M.D., Ph.D.、Vanderbilt-Ingram Cancer Center
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
2007年10月1日
一次修了 (実際)
2011年9月1日
研究の完了 (実際)
2013年12月1日
試験登録日
最初に提出
2007年10月26日
QC基準を満たした最初の提出物
2007年10月26日
最初の投稿 (見積もり)
2007年10月30日
学習記録の更新
投稿された最後の更新 (実際)
2017年6月8日
QC基準を満たした最後の更新が送信されました
2017年5月12日
最終確認日
2017年5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
- VICC-THO-0640
- P30CA068485 (米国 NIH グラント/契約)
- VU-VICC-THO-0640
- VU-VICC-070494
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。