Sorafenib and Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Chemotherapy
A Multicenter, Open-label, Phase II Study of Sorafenib in Combination With Erlotinib in Non-small Cell Lung Cancer (NSCLC) Refractory to One or Two Prior Chemotherapy Regimens
RATIONALE: Sorafenib and erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Giving sorafenib together with erlotinib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving sorafenib together with erlotinib works in treating patients with stage IIIB or stage IV non-small cell lung cancer that has not responded to chemotherapy.
調査の概要
状態
条件
詳細な説明
OBJECTIVES:
Primary
- To assess the response rate of sorafenib tosylate in combination with erlotinib hydrochloride in patients with stage IIIB-IV non-small cell lung cancer refractory to 1 or 2 prior chemotherapy regimens.
Secondary
- To assess the response duration in patients treated with this regimen.
- To assess the disease control rate in patients treated with this regimen.
- To assess the progression-free survival of patients treated with this regimen.
- To assess the overall survival of patients treated with this regimen.
- To assess the safety and tolerability of this regimen in these patients.
- To analyze biomarkers, including evaluation of EGFR expression, mutational analysis of EGFR and K-ras, and immunohistochemical analysis of EGFR downstream pathway (phospho-EGFR, phospho-AKT, phospho-Erk, phospho-STAT3).
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib hydrochloride once daily and oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Tissue samples are analyzed at the nucleic acid level for EGFR mutation (exon 18-21) and K-ras mutation (exon 2), DNA mutations via PCR, presence of EGFR protein by IHC, and downstream effectors of EGFR activation by IHC.
After completion of study therapy, patients are followed periodically.
研究の種類
入学 (予想される)
段階
- フェーズ2
連絡先と場所
研究場所
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-
-
Seoul、大韓民国、120-752
- 募集
- Yonsei Cancer Center at Yonsei University Medical Center
-
コンタクト:
- Joo-Hang Kim, MD
- 電話番号:82-2-2228-8131
- メール:kjhang@yuhs.ac
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer
- Advanced (stage IIIB-IV) or recurrent disease
- Must have failed 1 or 2 prior chemotherapy regimens, including platinum-containing regimen
At least 1 unidimensionally measurable lesion > 10 mm by spiral CT scan or > 20 mm by conventional CT scan
- Previously irradiated lesions cannot be included as sites of measurable disease unless clear tumor progression has been documented in the lesions since the end of radiotherapy
No known or suspected brain metastases
- Patients with clinical signs or symptoms that are suspicious of brain metastasis must have a pre-treatment CT scan or MRI of the brain
- Patients with prior brain metastases are eligible provided they have completed their treatment for brain metastases, no longer require corticosteroids, and are asymptomatic
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- WBC 4,000-12,000/μL
- Neutrophil ≥ 1,500/μL
- Platelet count ≥ 100,000/μL
- Hemoglobin ≥ 9.0 g/dL
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.0 times ULN
- Alkaline phosphatase ≤ 2.0 times ULN
- Serum creatinine ≤ 1.5 times ULN
- Not pregnant or nursing
- No active clinically serious infections
- No prior or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1), or any cancer curatively treated > 5 years before study
- Able to swallow oral medications
- No substance abuse or medical, psychological, or social conditions that may interfere with participation in the study or evaluation of the study results
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from all prior therapy
- No prior anti-EGFR targeted therapy
- At least 4 weeks since prior surgery
At least 4 weeks since prior and no concurrent radiotherapy
- No prior radiotherapy to the whole pelvis or chest or to ≥ 25% of the bone marrow
- No other concurrent anticancer agents (e.g., chemotherapy or immunotherapy agents) which might affect evaluation of study treatment
研究計画
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
- マスキング:なし(オープンラベル)
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 |
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Tumor response based on RECIST criteria
|
二次結果の測定
結果測定 |
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無増悪生存
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全生存
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疾病制御率
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Response duration in patients with confirmed objective response
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Biomarker analysis
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Joo-Hang Kim, MD、Yonsei University
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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。
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