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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (예상)
등록
단계
단계
- 2 단계
연락처 및 위치
연구 장소
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Seoul, 대한민국, 120-752
- 모병
- Yonsei Cancer Center at Yonsei University Medical Center
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연락하다:
- Joo-Hang Kim, MD
- 전화번호: 82-2-2228-8131
- 이메일: kjhang@yuhs.ac
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
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Tumor response based on RECIST criteria
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2차 결과 측정
2차 결과 측정
결과 측정 |
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무진행 생존
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전반적인 생존
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방역률
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Response duration in patients with confirmed objective response
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Biomarker analysis
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공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Joo-Hang Kim, MD, Yonsei University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 시작
기본 완료 (예상)
기본 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- CDR0000618003
- YONSEI-4-2008-0160
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