- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00041015
Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
An Open-Label, Multicenter, Randomized, Phase III Study Comparing Oral Topotecan/Cisplatin Versus Etoposide/Cisplatin As Treatment For Chemotherapy-Naive Patients With Extensive Disease - Small Cell Lung
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating extensive-stage small cell lung cancer.
PURPOSE: Randomized phase III trial to compare different chemotherapy regimens in treating patients who have extensive-stage small cell lung cancer.
연구 개요
상세 설명
OBJECTIVES:
- Compare the overall survival of patients with chemotherapy-naive extensive stage small cell lung cancer treated with cisplatin and oral topotecan vs cisplatin and etoposide.
- Compare the response rates, response duration, and time to progression in patients treated with these regimens.
- Compare the tolerability of these regimens in these patients.
- Compare the patient-perceived disease status and well being in patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to gender, ECOG performance status (0 vs 1 vs 2), lactate dehydrogenase (less than 1.5 times upper limit of normal (ULN) vs 1.5 times ULN or greater), and country. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral topotecan once daily on days 1-5 and cisplatin IV on day 5.
- Arm II: Patients receive cisplatin IV on day 1 and etoposide IV over at least 30 minutes on days 1-3.
Treatment in both arms repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, prior to each course, at 4 weeks after study, and then every 4 weeks for 16 weeks.
Patients are followed at 4 weeks, every 4 weeks for 16 weeks, and then every 3 months thereafter.
PROJECTED ACCRUAL: Approximately 760 patients (380 per treatment arm) will be accrued for this study within 18 months.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
-
-
Ohio
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Cleveland, Ohio, 미국, 44106-5065
- Ireland Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed extensive stage small cell lung carcinoma (SCLC)
- No prior chemotherapy for SCLC OR
- No chemotherapy within 5 years of diagnosis of SCLC
- Prior radiotherapy to measurable or nonmeasurable disease field allowed provided radiotherapy was completed at least 6 weeks ago and the disease is demonstrated to be progressing
No clinical signs or symptoms of brain and/or leptomeningeal metastases by CT scan or MRI
- Brain and/or leptomeningeal metastases that are asymptomatic on neurologic exam are allowed provided metastases do not require corticosteroid therapy to control symptoms
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Hemoglobin at least 9.0 g/dL
- WBC at least 3,500/mm3
- Platelet count at least 100,000/mm3
- Neutrophil count at least 1,500/mm3
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- SGOT and SGPT no greater than 2 times the upper limit of normal (ULN) (5 times ULN if liver metastases present)
- Alkaline phosphatase no greater than 2 times ULN (5 times ULN if liver metastases present)
Renal:
- Creatinine no greater than 1.5 mg/dL
- Creatinine clearance at least 60 mL/min
- No pre-existing renal impairment that would preclude cisplatin use
Gastrointestinal:
No clinical evidence of any gastrointestinal (GI) conditions including:
- Removal of a portion of the stomach
- History of recent obstruction of the GI tract
- GI autonomic neuropathy
- Ulcerative colitis
- Crohn's disease
- Malabsorption syndrome
- Treatment with cyclosporine that would alter absorption or GI motility
- No other conditions that would preclude absorption of oral topotecan
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception for 3 months prior to study, during, and for at least 1 month after study
- No active infection
- No other prior or concurrent malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or localized low-grade prostate cancer
- No other concurrent severe medical problems that would expose the patient to extreme risk or preclude study compliance
- No prior allergic reactions to compounds chemically related to study drugs
- No pre-existing hearing impairment that would preclude cisplatin use
- No overall medical condition for which study drugs would be inappropriate
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent immunotherapy for SCLC
Chemotherapy:
- See Disease Characteristics
- No other concurrent chemotherapy for SCLC
Endocrine therapy:
- See Disease Characteristics
- No concurrent hormonal therapy for SCLC
Radiotherapy:
- See Disease Characteristics
- At least 24 hours since prior radiotherapy with no expected bone marrow suppression
- Recovered from prior palliative radiotherapy (e.g, nausea and vomiting from radiation of the epigastrium)
- No concurrent radiotherapy for SCLC
- No concurrent radiotherapy for palliation of bone metastases or CNS lesions unless approved by the investigator
Surgery:
- At least 3 weeks since prior major surgery (a shorter period is allowed if deemed in the best interest of the patient)
Other:
- More than 30 days or 5 half-lives (whichever is longer) since prior investigational drugs
- No other concurrent investigational therapy for SCLC
- No concurrent cyclosporine
- No concurrent drugs that would preclude absorption of oral topotecan
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: oral topotecan plus cisplatin IV
oral topotecan once daily on days 1-5 and cisplatin IV on day 5
|
|
실험적: Cisplatin IV plus etoposide IV
Cisplatin IV on day 1 and etoposide IV over at least 30 minutes
|
공동 작업자 및 조사자
수사관
- 연구 의자: Nathan Levitan, MD, Case Comprehensive Cancer Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- SKF1501
- CWRU-070144
- SB-389
- SB-SKF-104864A
- SB-SKF-1501
- NCI-G02-2092
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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