- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00006257
SU5416 and Paclitaxel in Treating Patients With Advanced Cancer
Phase I Trial of SU5416 in Combination With Weekly Paclitaxel in Patients With Advanced Malignancies
RATIONALE: Drugs such as SU5416 may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining SU5416 with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining SU5416 and paclitaxel in treating patients who have advanced cancer.
연구 개요
상세 설명
OBJECTIVES:
- Determine the maximum tolerated dose of SU5416 when combined with paclitaxel in patients with advanced malignancies.
- Determine the toxicities and pharmacokinetics of this regimen in these patients.
- Determine the effects of this regimen on a variety of histological and molecular biomarkers of angiogenesis, including in vitro activity assays of endothelial cell proliferation, migration, and invasion.
OUTLINE: This is a dose escalation study of SU5416.
Patients receive SU5416 IV over 1 hour twice weekly during the first week. During subsequent courses, SU5416 is administered on days 1, 4, 8, 11, 15, 18, 22, and 25. Paclitaxel begins on the second week of therapy and is administered IV over 1 hour on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of SU5416 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study within 12-18 months.
연구 유형
단계
- 1단계
연락처 및 위치
연구 장소
-
-
California
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Duarte, California, 미국, 91010-3000
- Cancer Center and Beckman Research Institute, City of Hope
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Los Angeles, California, 미국, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Sacramento, California, 미국, 95817
- University of California Davis 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 proven advanced malignancy for which no satisfactory treatment exists
Must have tumor accessible by biopsy
- Minimum of 1 baseline biopsy required
- No brain metastases or primary CNS tumor
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- WHO 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- SGOT and SGPT less than 2 times upper limit of normal unless due to presence of tumor
- Bilirubin normal
Renal:
- Creatinine no greater than 1.5 mg/dL
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- No uncompensated coronary artery disease by ECG or physical examination
- No myocardial infarction or severe unstable/angina within the past 6 months
- No severe peripheral vascular disease associated with diabetes mellitus
- No severe deep vein or arterial thrombosis within the past 3 months
Pulmonary:
- No pulmonary embolism within the past 3 months
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No unstable or severe concurrent medical condition
- No active uncontrolled infection
- No history of allergic reaction to paclitaxel or Cremophor
- No greater than grade 1 peripheral neuropathy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior SU5416
Chemotherapy:
- No prior paclitaxel
- Greater than 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered
Endocrine therapy:
- Not specified
Radiotherapy:
- Greater than 4 weeks since prior radiotherapy and recovered
Surgery:
- See Disease Characteristics
Other:
- Recovered from any prior investigational agents
- No other concurrent investigational agents
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
공동 작업자 및 조사자
수사관
- 연구 의자: Przemyslaw W. Twardowski, MD, City of Hope Comprehensive Cancer Center
연구 기록 날짜
연구 주요 날짜
연구 시작
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
- CDR0000068191
- P30CA033572 (미국 NIH 보조금/계약)
- U01CA062505 (미국 NIH 보조금/계약)
- CHNMC-PHI-30
- CHNMC-IRB-99098
- NCI-T99-0086
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