Gemcitabine Plus Docetaxel in Treating Patients With Unresectable or Metastatic Liver Cancer
Phase II Trial of Gemcitabine and Docetaxel in Patients With Unresectable or Metastatic Hepatocellular Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus docetaxel in treating patients who have unresectable or metastatic liver cancer.
연구 개요
상세 설명
OBJECTIVES:
- Assess the six-month overall survival of patients with unresectable or metastatic hepatocellular carcinoma treated with gemcitabine and docetaxel.
- Determine tumor response and time to progression in this patient population treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Assess the pharmacokinetics of docetaxel in patients treated with this regimen.
OUTLINE: Patients receive docetaxel IV over 15-60 minutes and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks. Patients achieving complete response after 2 courses of therapy receive 2 additional courses of therapy. Patients with stable disease or partial response continue therapy until disease progression.
Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
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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Florida
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Jacksonville, Florida, 미국, 32224
- Mayo Clinic
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Georgia
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Atlanta, Georgia, 미국, 30342-1701
- CCOP - Atlanta Regional
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Hawaii
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Honolulu, Hawaii, 미국, 96813
- MBCCOP - Hawaii
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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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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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North Dakota
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Bismarck, North Dakota, 미국, 58501-5505
- Medcenter One Health System
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Ohio
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Toledo, Ohio, 미국, 43623-3456
- CCOP - Toledo Community Hospital
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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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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:
- Histologically confirmed unresectable or metastatic hepatocellular carcinoma not amenable to combined radiotherapy and chemotherapy or orthotopic liver transplantation
- Measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension as at least 20 mm
- Evidence of disease progression by serial imaging or biochemical evidence of a rising alpha-fetoprotein by serial testing
No history of brain or other CNS metastases not amenable to local therapy
- Locally treatable CNS lesions (i.e., lesions treatable with surgery or radiosurgery) allowed if no evidence of CNS progression for at least 4 weeks after completion of therapy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10.0 g/dL
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST no greater than 2.5 times ULN
Renal
- Creatinine no greater than 1.5 times ULN
Other
- No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior hypersensitivity reaction to taxanes or other drugs formulated with polysorbate 80
- No grade 2 or greater peripheral neuropathy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 4 weeks since prior biologic therapy or immunotherapy
- No concurrent immunotherapy
Chemotherapy
- See Disease Characteristics
- Prior chemotherapy (excluding gemcitabine) for radiosensitization allowed
- At least 4 weeks since prior chemotherapy
- At least 6 months since prior chemoembolization
- No prior chemotherapy for metastatic disease
- No other concurrent chemotherapy
Endocrine therapy
- At least 4 weeks since prior hormonal therapy
Radiotherapy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
- No prior radiotherapy to 25% or more of bone marrow
- No concurrent radiotherapy
Surgery
- See Disease Characteristics
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: docetaxel + gemcitabine
Patients receive docetaxel IV over 15-60 minutes and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks. Patients achieving complete response after 2 courses of therapy receive 2 additional courses of therapy. Patients with stable disease or partial response continue therapy until disease progression. Patients are followed every 3 months for 1 year and then every 6 months for 4 years. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
six-month overall survival
기간: at 6 months
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at 6 months
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
진행 시간
기간: 최대 5년
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최대 5년
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tumor response
기간: Up to 5 years
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Up to 5 years
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Alberts SR, Reid JM, Morlan BW, Farr GH Jr, Camoriano JK, Johnson DB, Enger JR, Seay TE, Kim GP. Gemcitabine and docetaxel for hepatocellular carcinoma: a phase II North Central Cancer Treatment Group clinical trial. Am J Clin Oncol. 2012 Oct;35(5):418-23. doi: 10.1097/COC.0b013e318219863b.
- Kim GP, Alberts SR, Tschetter LK, et al.: Gemcitabine and docetaxel in patients with measurable unresectable or metastatic hepatocellular carcinoma (HCC), a North Central Cancer Treatment Group (NCCTG) phase II trial. [Abstract] J Clin Oncol 22 (Suppl 14): A-4270, 380s, 2004.
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
- NCCTG-N0041
- NCI-2012-02349 (레지스트리 식별자: CTRP (Clinical Trials Reporting System))
- CDR0000068019 (레지스트리 식별자: PDQ (Physician Data Query))
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