- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00003281
Topotecan and Paclitaxel in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer
Phase II Trial of Topotecan and Paclitaxel in Previously Treated Patients With Relapsed Small Cell Lung Cancer
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.
PURPOSE: Phase II trial to study the effectiveness of topotecan and paclitaxel in treating patients who have recurrent or refractory small cell lung cancer.
연구 개요
상세 설명
OBJECTIVES:
- Determine the toxicity of combination topotecan and paclitaxel in previously treated patients with small cell lung cancer.
- Determine the response rate and survival in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to length of time since prior treatment (less than 3 months (stratum A) vs 3 months or more (stratum B)). Stratum A closed to accrual effective 06/20/2000.
Patients receive topotecan IV over 30 minutes on days 1-3 and paclitaxel IV over 3 hours on day 3. Courses repeat every 4 weeks.
Patients who achieve partial response or stable disease continue treatment in the absence of complete response or disease progression. Patients who develop disease progression in the CNS only should receive whole brain radiotherapy and then continue treatment. Patients who achieve complete remission receive a maximum of 6 courses of treatment. Patients may then undergo prophylactic cranial irradiation and/or thoracic radiotherapy at the discretion at the attending physician.
Patients are followed every 3 months for 2 years and then at 3 years after study.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Arizona
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Scottsdale, Arizona, 미국, 85259-5404
- CCOP - Scottsdale Oncology Program
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Illinois
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Peoria, Illinois, 미국, 61602
- CCOP - Illinois Oncology Research Association
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Urbana, Illinois, 미국, 61801
- CCOP - Carle Cancer Center
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Iowa
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Cedar Rapids, Iowa, 미국, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, 미국, 50309-1016
- CCOP - Iowa Oncology Research Association
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Sioux City, Iowa, 미국, 51101-1733
- Siouxland Hematology-Oncology
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Kansas
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Wichita, Kansas, 미국, 67214-3882
- CCOP - Wichita
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Louisiana
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New Orleans, Louisiana, 미국, 70121
- CCOP - Ochsner
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Minnesota
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Duluth, Minnesota, 미국, 55805
- CCOP - Duluth
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, 미국, 56303
- CentraCare Health Plaza
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Nebraska
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Omaha, Nebraska, 미국, 68131
- CCOP - Missouri Valley Cancer Consortium
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North Dakota
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Bismarck, North Dakota, 미국, 58501
- Medcenter One Health System
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Grand Forks, North Dakota, 미국, 58201
- Altru Health Systems
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Ohio
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Toledo, Ohio, 미국, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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Pennsylvania
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Danville, Pennsylvania, 미국, 17822-2001
- CCOP - Geisinger Clinic and Medical Center
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South Dakota
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Rapid City, South Dakota, 미국, 57709
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, 미국, 57104
- CCOP - Sioux Community Cancer Consortium
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Saskatchewan
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Regina, Saskatchewan, 캐나다, S4T 7T1
- Allan Blair Cancer Centre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
- Stratum A (less than 3 months since prior therapy) closed to accrual effective 06/20/2000)
Histologically or cytologically confirmed recurrent or refractory small cell lung cancer
- Only 1 prior regimen allowed (an alternating regimen with cyclophosphamide/doxorubicin/vincristine and etoposide/cisplatin is acceptable)
- No mixed histology
- Measurable or evaluable disease that has not been in the field of prior radiotherapy
- No uncontrolled CNS metastases (treated CNS metastases eligible)
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Hematopoietic:
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR
- Direct bilirubin normal
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No unstable angina pectoris
- No uncontrolled congestive heart failure
- No myocardial infarction within the past 3 months
Other:
- No uncontrolled infections
- No other concurrent malignancy except skin cancer or localized prostate cancer
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- No prior topoisomerase I inhibitor (e.g., topotecan or irinotecan) or taxane (e.g., paclitaxel or docetaxel)
- At least 3 months since other prior chemotherapy
Radiotherapy:
- See Disease Characteristics
- At least 2 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- At least 3 weeks since any prior major surgery
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: topotecan + paclitaxel + radiotherapy
Patients receive topotecan IV over 30 minutes on days 1-3 and paclitaxel IV over 3 hours on day 3. Courses repeat every 4 weeks. Patients who achieve partial response or stable disease continue treatment in the absence of complete response or disease progression. Patients who develop disease progression in the CNS only should receive whole brain radiotherapy and then continue treatment. Patients who achieve complete remission receive a maximum of 6 courses of treatment. Patients may then undergo prophylactic cranial irradiation and/or thoracic radiotherapy at the discretion at the attending physician. Patients are followed every 3 months for 2 years and then at 3 years after study. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
응답률
기간: 최대 5년
|
최대 5년
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
활착
기간: 최대 5년
|
최대 5년
|
공동 작업자 및 조사자
간행물 및 유용한 링크
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 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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