- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00040989
BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer
Phase II Study of BAY 56-3722 in Patients With Recurrent, Unresectable, or Metastatic Renal Cell Carcinoma
RATIONALE: BAY 56-3722 may stop the growth of cancer cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of BAY 56-3722 in treating patients who have recurrent, unresectable, or metastatic kidney cancer.
연구 개요
상세 설명
OBJECTIVES:
- Determine the tumor response rate of patients with recurrent, unresectable, or metastatic renal cell carcinoma treated with BAY 56-3722.
- Determine the duration of response, time to progression, and survival of patients treated with this drug.
- Determine the qualitative and quantitative toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive BAY 56-3722 IV over 30 minutes on days 1-3. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 20-140 patients will be accrued for this study.
연구 유형
단계
- 2 단계
연락처 및 위치
연구 장소
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Arkansas
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Little Rock, Arkansas, 미국, 72205
- University of Arkansas for Medical Sciences
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California
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Los Angeles, California, 미국, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, 미국, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Colorado
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Denver, Colorado, 미국, 80010
- University Of Colorado Cancer Center
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Florida
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Miami, Florida, 미국, 33176
- Oncology-Hematology Group of South Florida
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Georgia
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Atlanta, Georgia, 미국, 30322
- Emory University Hospital - Atlanta
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Decatur, Georgia, 미국, 30033
- Veterans Affairs Medical Center - Atlanta (Decatur)
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Fort Gordon, Georgia, 미국, 30905-5650
- Dwight David Eisenhower Army Medical Center
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Illinois
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Maywood, Illinois, 미국, 60153
- Loyola University Medical Center
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Kansas
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Kansas City, Kansas, 미국, 66160-7353
- University of Kansas Medical Center
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Louisiana
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New Orleans, Louisiana, 미국, 70112
- Tulane University School of Medicine
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Shreveport, Louisiana, 미국, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Dana-Farber Cancer Institute
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Missouri
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Columbia, Missouri, 미국, 65203
- Ellis Fischel Cancer Center - Columbia
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Nebraska
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Omaha, Nebraska, 미국, 68198-3330
- University of Nebraska Medical Center
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New Hampshire
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Lebanon, New Hampshire, 미국, 03756-0002
- Norris Cotton Cancer Center
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New Jersey
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Hackensack, New Jersey, 미국, 07601
- Hackensack University Medical Center
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New Brunswick, New Jersey, 미국, 08903
- Cancer Institute of New Jersey
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New York
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Rochester, New York, 미국, 14642-0001
- University of Rochester Medical Center
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Ohio
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Cleveland, Ohio, 미국, 44195
- Cleveland Clinic Taussig Cancer Center
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Oregon
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Portland, Oregon, 미국, 97239
- Oregon Cancer Institute
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104-4283
- University of Pennsylvania Cancer Center
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South Carolina
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Greenville, South Carolina, 미국, 29615
- Cancer Centers of the Carolinas
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Texas
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Dallas, Texas, 미국, 75390
- Simmons Cancer Center - Dallas
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Houston, Texas, 미국, 77030
- Baylor College of Medicine
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San Antonio, Texas, 미국, 78229-3264
- Cancer Therapy and Research Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
- Histologically confirmed renal cell carcinoma (RCC)
- Recurrent AND unresectable disease OR
- Unresectable disease OR
- Metastatic disease
- At least 1 bidimensionally measurable lesion by CT scan or MRI
- No metastatic brain or meningeal tumors unless more than 3 months since prior surgery and/or gamma knife radiosurgery, 2 subsequent negative imaging studies at least 4 weeks apart, clinically stable, and no concurrent corticosteroids or anticonvulsants
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9 g/dL
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST and ALT less than 2.5 times ULN (5 times ULN if liver metastases present)
- No chronic hepatitis B or C
Renal:
- Creatinine no greater than 1.5 mg/dL
- Calcium normal
Cardiovascular:
- No clinically evident congestive heart failure
- No serious cardiac arrhythmias
- No symptoms of coronary heart disease
- No symptoms of ischemia
Other:
- HIV negative
- No active infections requiring systemic antibacterial, antifungal, or antiviral therapy
- No other malignancy within the past 3 years except carcinoma in situ of the cervix, adequately treated basal cell carcinoma, or superficial bladder tumors (Ta, Tis, or T1)
- No substance abuse
- No medical, psychological, or social conditions that would preclude study
- No known or suspected allergy to study drug or any other study agents
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 6 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior anticancer vaccine therapy
- No prior bone marrow transplantation or stem cell rescue
- More than 4 weeks since prior thalidomide and bevacizumab
- At least 4 weeks since prior interleukin-2 and interferon
- No more than 2 prior regimens
- No concurrent bone marrow transplantation or stem cell rescue
Chemotherapy:
- No prior cytotoxic chemotherapy
- No concurrent cytotoxic chemotherapy
Endocrine therapy:
- See Disease Characteristics
- No prior hormonal therapy for RCC
- No concurrent hormonal therapy for RCC
Radiotherapy:
- See Disease Characteristics
- More than 4 weeks since prior radiotherapy
- No prior radiotherapy to indicator lesion unless progression is documented
Surgery:
- See Disease Characteristics
- More than 3 weeks since prior major surgery
Other:
- At least 4 weeks since prior investigational anticancer drugs
- No other concurrent investigational anticancer drugs
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
공동 작업자 및 조사자
수사관
- 연구 의자: Barbara J. Gitlitz, MD, Jonsson Comprehensive Cancer Center
연구 기록 날짜
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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