- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00258284
Capecitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer
Phase II Trial of Capecitabine (Xeloda) and Weekly Docetaxel (Taxotere) in Metastatic Androgen Independent Prostate Carcinoma
RATIONALE: Drugs used in chemotherapy, such as capecitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving capecitabine together with docetaxel works in treating patients with metastatic prostate cancer.
연구 개요
상세 설명
OBJECTIVES:
Primary
- Determine the response rate in patients with androgen-independent metastatic adenocarcinoma of the prostate treated with capecitabine and docetaxel.
Secondary
- Determine the toxicity of this regimen in these patients.
- Determine the progression-free survival, time to treatment failure, and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Michigan
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Detroit, Michigan, 미국, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
- Metastatic disease
- Androgen-independent disease
Progressive disease, as documented by ≥ 1 of the following criteria:
Rising prostate-specific antigen (PSA) despite androgen deprivation therapy and anti-androgen withdrawal
- Demonstrates a rising PSA trend with 2 successive elevations ≥ 1 week apart
- Measurable disease progression
Nonmeasurable disease progression, defined as the following:
- PSA ≥ 5 ng/mL
- New areas of bone metastases on bone scan
Serum testosterone ≤ 0.5 ng/mL (castrate level)
- Concurrent luteinizing hormone-releasing hormone agonist therapy required for medically castrated patients
PATIENT CHARACTERISTICS:
Performance status
- Zubrod 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- Absolute neutrophil count ≥ 1,500/ mm^3
- Hemoglobin ≥ 8.0 g/dL
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin normal
Transaminases meeting 1 of the following criteria:
- AST and/or ALT ≤ 2.5 times upper limit of normal (ULN) if alkaline phosphatase (AP) normal
- AP ≤ 4 times ULN if AST and/or ALT normal
Renal
- Creatinine clearance ≥ 50 mL/min OR
- Creatinine ≤ 2 mg/dL
Cardiovascular
- No congestive heart failure
- No second- or third-degree heart block
- No myocardial infarction within the past 3 months
Other
- Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- No other malignancy within the past 2 years except adequately treated skin cancer or other cancer in complete remission
- No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- No peripheral neuropathy ≥ grade 2
PRIOR CONCURRENT THERAPY:
Chemotherapy
- No prior chemotherapy for metastatic disease
Endocrine therapy
- See Disease Characteristics
- More than 4 weeks since prior flutamide
- More than 6 weeks since prior bicalutamide or nilutamide
Radiotherapy
- At least 4 weeks since prior radiotherapy
Other
- At least 28 days since prior investigational drugs for prostate cancer
- No other concurrent anti-cancer therapy
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 & Capecitabine
Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR
|
Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR
다른 이름들:
Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 5-18.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients achieving a complete response (CR) receive 2 additional courses of therapy beyond CR
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Response rate by RECIST criteria after every 2 courses
기간: at cycle 2 and every other cycle thereafter
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at cycle 2 and every other cycle thereafter
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Toxicity at 30 days after last treatment
기간: Every week during treatment cycles
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Every week during treatment cycles
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Progression-free survival
기간: Every 2 cycles
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Every 2 cycles
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Time to treatment failure
기간: Every 2 cycles
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From date of registration to date of progressive disease, or date patient is taken off study for any other reason.
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Every 2 cycles
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Overall survival
기간: Every 2 cycles
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Every 2 cycles
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Effect of treatment on biological correlates (thymidine phosphorylase, dihydropyrimidine dehydrogenase, thymidylate synthase)
기간: Every week during treatment cycles
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Every week during treatment cycles
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공동 작업자 및 조사자
수사관
- 연구 의자: Ulka N. Vaishampayan, MD, Barbara Ann Karmanos Cancer Institute
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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