Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer
Phase Ib/II Neoadjuvant Trial of the Farnesyltransferase Inhibitor, R115777 With Docetaxel and Capecitabine for Patients With Stage IIIA or IIIB Breast Cancer
연구 개요
상태
상세 설명
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose and recommended dose of capecitabine in combination with docetaxel and tipifarnib in patients with locally advanced or metastatic solid tumors. (Phase Ib) II. Determine the complete pathological and clinical response rate in patients with stage IIIA or IIIB breast cancer treated with this regimen. (Phase II)
SECONDARY OBJECTIVES:
I. Determine the toxicity of this regimen in these patients. II. Determine disease-free and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of capecitabine. Patients in phase II are stratified according to type of breast cancer (inflammatory vs noninflammatory).
Phase Ib: Patients receive oral tipifarnib twice daily and oral capecitabine twice daily on days 1-14 and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Phase II: Patients receive oral tipifarnib twice daily for 6 days. Beginning at least 48 hours after completion of the initial dose of tipifarnib, patients receive treatment as in phase Ib for up to 6 courses at the MTD of capecitabine. Patients in phase Ib are followed at 3 months.
Patients in phase II are followed every 4 months for up to 5 years.
PROJECTED ACCRUAL: A total of 24-53 patients (9-18 for phase Ib and 15-35 for phase II) will be accrued for this study within 14-35 months.
연구 유형
등록 (실제)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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Arizona
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Scottsdale, Arizona, 미국, 85259
- Mayo Clinic in Arizona
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District of Columbia
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Washington, District of Columbia, 미국, 20060
- Howard University Cancer Center CCOP
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Florida
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Jacksonville, Florida, 미국, 32224-9980
- Mayo Clinic in Florida
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Michigan
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Detroit, Michigan, 미국, 48201
- Barbara Ann Karmanos Cancer Institute
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Minnesota
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic
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Missouri
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Saint Louis, Missouri, 미국, 63110
- Washington University School of Medicine
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Wisconsin
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Milwaukee, Wisconsin, 미국, 53201
- University of Wisconsin Medical School
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Histologically or cytologically confirmed solid tumor
- Locally advanced or metastatic
- No known standard therapy that is potentially curative or definitely capable of extending life expectancy
No history of metastatic brain disease within the past 6 months
- Treated metastatic brain disease is allowed provided disease has been stable for more than 6 months and does not require concurrent steroids or anti-seizure medication
Histologically confirmed breast cancer
- Stage IIIA or stage IIIB, including ipsilateral palpable supraclavicular lymph node(s) without other distant metastasis
Invasive disease confirmed by 1 of the following*:
- Incisional biopsy
- Punch biopsy (applicable for clinical T4b tumors)
- Core needle (cutting needle) biopsies
- No distant metastatic disease
Hormone receptor status:
- Not specified
- Male or female
- Performance status - ECOG 0-1
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10.0 g/dL
- Bilirubin no greater than upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2.5 times ULN
- AST no greater than 2.5 times ULN
- Creatinine no greater than 1.25 times ULN
- Creatinine clearance at least 50 mL/min
- No cardiac arrhythmia
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infection requiring antibiotics
- No diabetes
- No symptomatic neurologic condition
- No other uncontrolled serious medical condition
- No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No history of hypersensitivity to intravenous paclitaxel or other medication containing Cremophor EL or polysorbate 80 as a carrier (phase Ib)
Phase Ib only:
- More than 4 weeks since prior immunotherapy
- More than 4 weeks since prior biologic therapy
- No concurrent immunotherapy
Phase Ib and II:
- No concurrent prophylactic filgrastim (G-CSF)
Phase Ib only:
- More than 1 year since prior adjuvant docetaxel before metastatic relapse
- More than 4 weeks since prior chemotherapy and recovered
No prior capecitabine AND docetaxel (in combination or as single agents)
- Prior capecitabine OR docetaxel allowed
- No other concurrent chemotherapy
Phase II only:
- No prior cytotoxic chemotherapy for breast cancer
Phase Ib only:
- More than 3 weeks since prior radiotherapy
- No prior radiotherapy to more than 25% of bone marrow
- No concurrent radiotherapy
Phase II only:
- No prior radiotherapy for breast cancer
Phase Ib only:
- More than 4 weeks since prior major surgery
Phase II only:
- No prior surgery (other than core or incisional biopsy for diagnostic purposes) for breast cancer
Phase Ib only:
- No other ancillary investigational therapy
Phase Ib and II:
- No concurrent sorivudine or brivudine
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 |
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실험적: Treatment (tipifarnib, capecitabine, docetaxel)
Phase Ib: Patients receive oral tipifarnib twice daily and oral capecitabine twice daily on days 1-14 and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Phase II: Patients receive oral tipifarnib twice daily for 6 days. Beginning at least 48 hours after completion of the initial dose of tipifarnib, patients receive treatment as in phase Ib for up to 6 courses at the MTD of capecitabine. |
상관 연구
상관 연구
주어진 IV
다른 이름들:
주어진 PO
다른 이름들:
Given orally (PO)
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Dose-limiting toxicity (DLT) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (Phase I)
기간: 21 days
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21 days
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Pathologic complete response rate (Phase II)
기간: Up to 5 years
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Estimated by the number of patients with a complete pathologic response divided by the total number of evaluable patients.
Ninety-five percent confidence intervals for the true pathologic complete response probability will be calculated according to the approach of Duffy and Santner.
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Up to 5 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Clinical tumor response (complete response [CR] or partial response [PR]) (Phase I)
기간: Up to 5 years
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Clinical responses will be summarized by simple descriptive summary statistics.
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Up to 5 years
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Overall survival
기간: From registration to death due to any cause, assessed up to 5 years
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The distribution of survival time will be estimated using the method of Kaplan-Meier.
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From registration to death due to any cause, assessed up to 5 years
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Toxicity as assessed by the National Cancer Institute (NCI) CTCAE version 3.0
기간: Up to 5 years
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Up to 5 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Philip Philip, Mayo Clinic
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
- NCI-2012-01442 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
- P30CA015083 (미국 NIH 보조금/계약)
- N01CM62205 (미국 NIH 보조금/계약)
- WSU-C-2679
- MAYO-MC0131
- NCI-5599
- CDR0000331694
- MC0131 (기타 식별자: Mayo Clinic)
- 5599 (기타 식별자: CTEP)
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