- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00052507
Bortezomib in Treating Patients With Metastatic or Recurrent Colorectal Cancer
A Phase II Study Of PS-341 In Patients With Metastatic Colorectal Cancer
RATIONALE: Bortezomib may interfere with the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have metastatic or recurrent colorectal cancer.
연구 개요
상세 설명
OBJECTIVES:
- Determine the efficacy of bortezomib, in terms of response rate and stable disease rate, in patients with recurrent or metastatic colorectal cancer.
- Determine the toxicity of this drug in these patients.
- Determine the time to progression and response duration in patients treated with this drug.
- Determine whether there is a relationship between levels of transcription factors NF kappa B and HIF-1 alpha and clinical outcome in patients treated with this drug.
OUTLINE: This is an open-label study.
Patients receive bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 2-4 months.
연구 유형
단계
- 2 단계
연락처 및 위치
연구 장소
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Ontario
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Hamilton, Ontario, 캐나다, L8V 5C2
- Cancer Care Ontario-Hamilton Regional Cancer Centre
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London, Ontario, 캐나다, N6A 4L6
- Cancer Care Ontario-London Regional Cancer Centre
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Ottawa, Ontario, 캐나다, K1H 1C4
- Ottawa Regional Cancer Centre
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Toronto, Ontario, 캐나다, M5G 2M9
- Princess Margaret Hospital at University Health Network
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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 adenocarcinoma of the colon or rectum that is incurable with conventional therapy
- Metastatic or recurrent disease
- At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques or at least 10 mm by spiral CT scan
- Disease must be accessible to biopsy
- No known brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1 OR
- Karnofsky 70-100%
Life expectancy
- More than 3 months
Hematopoietic
- Absolute granulocyte count at least 1,500/mm^3
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.25 times upper limit of normal (ULN)
- AST or ALT no greater than 3 times ULN (less than 5 times ULN if liver metastases present)
Renal
- Creatinine no greater than 1.25 times UNL OR
- Creatinine clearance at least 50 mL/min
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled concurrent illness
- No ongoing or active infection
- No other active malignancy within the past 3 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
- No grade 1 or greater peripheral neuropathy due to prior chemotherapy
- No significant traumatic injury within the past 21 days
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No more than 1 line of prior chemotherapy (including any combination of fluorouracil, irinotecan, and/or oxaliplatin) for metastatic disease
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- Prior adjuvant chemotherapy allowed
- No concurrent cytotoxic chemotherapy
Radiotherapy
- More than 4 weeks since prior radiotherapy and recovered
- No prior radiotherapy to measurable target lesion unless disease progression has occurred after radiotherapy
- No concurrent radiotherapy to the sole site of measurable disease
Surgery
- More than 21 days since prior major surgery
Other
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 마스킹: 없음(오픈 라벨)
공동 작업자 및 조사자
수사관
- 연구 의자: Amit M. Oza, MD, Princess Margaret Hospital, Canada
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 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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