- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01016769
Temsirolimus + Weekly Paclitaxel + Carboplatin for Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)
A Phase I/II Study of Temsirolimus + Weekly Paclitaxel + Carboplatin for Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)
연구 개요
연구 유형
등록 (실제)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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New Jersey
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Basking Ridge, New Jersey, 미국, 07939
- Memorial Sloan Kettering Cancer Center at Basking Ridge
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New York
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Commack, New York, 미국, 11725
- Memorial Sloan Kettering Cancer Center @ Suffolk
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New York, New York, 미국, 10065
- Memorial Sloan Kettering Cancer Center
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Rockville Centre, New York, 미국
- Memorial Sloan Kettering at Mercy Medical Center
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Sleepy Hollow, New York, 미국, 10591
- Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients must have microscopically confirmed head and neck squamous cell carcinoma (HNSCC), recurrent and/or metastatic.
- Confirmation of HNSCC may be obtained from the primary site or metastatic disease.
- Patients must be at least 18 years of age.
- Karnofsky Performance status must be ≥ 70%.
- Disease must be measurable by RECIST criteria.
- At least 6 weeks must have elapsed from previous radiation therapy. Patient must have recovered from the acute toxic effects of treatment prior to study enrollment.
- Adequate organ function, as follows:
- Adequate bone marrow reserve: absolute neutrophil count (ANC) ≥ 1.5 X 109/L, platelets ≥ 100 X 109/L, and hemoglobin ≥ 9 g/dL.
- Hepatic: total bilirubin within normal limits (≤ 1.0 mg/dL); alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5 X ULN (upper limit of normal)
- Renal: Serum creatinine ≤ 1.3 mg/dL. Patients with serum creatinine > 1.3 mg/dL may be eligible if creatinine clearance (CrCl) ≥ 45 mL/min based on the standard Cockroft and Gault formula.
- Patients of childbearing potential must have a negative serum pregnancy test within 14 days of treatment. Patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.
- Patients must sign an informed consent document.
Exclusion Criteria:
- Previous exposure to temsirolimus or other mTOR inhibitors
- More than 2 prior cytotoxic regimens in the recurrent/metastatic disease setting
- History of any brain metastases
- Patients who require concomitant medications that are metabolized by hepatic CYP3A4, due to potential drug-drug interaction with temsirolimus
- Patients with known active interstitial pneumonitis
- Active infection or serious underlying medical condition that would impair the patient's ability to receive protocol treatment.
- Women who are pregnant or lactating
- Other active malignancy, other than indolent malignancies which the investigator determines are unlikely to interfere with treatment and safety analysis
- Diagnosis of Nasopharyngeal cancer is excluded.
- Patients with multifocal peripheral sensory alterations or paresthesias (including tingling) interfering with function, per patient report (example: activities of daily living)
- Therapeutic anticoagulation with Coumadin (warfarin)
- Hypertriglyceridemia ≥ grade 2 (CTCAE version 3.0).
- Impaired lung function: O2 saturation 88% or less at rest on room air by Pulse Oximetry. If O2 saturation is ≤ 88% at rest, further pulmonary function tests (PFTs) should be ordered to confirm normal pulmonary function and eligibility.
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: Temsirolimus + Weekly Paclitaxel + Carboplatin
In Part 1 (Phase I) of the study, the primary endpoint is to establish the phase II recommended dose for the combination of temsirolimus + weekly paclitaxel + carboplatinPart 1 (Phase I) features a standard 3 + 3 phase I dose escalation design. Up to 3 dose levels are planned in the Phase I portion of the study. In Part 2 (Phase II) of the study, the primary endpoint is to determine the objective response rate (CR or PR) after two cycles (approximately 6 weeks) of treatment with the combination of temsirolimus + weekly paclitaxel + carboplatin as palliative therapy for recurrent or metastatic HNSCC. A two-stage design will be employed. |
Temsirolimus Per dose escalation scheme Level 1 (15 mg) 2 (20 mg) Level 3 (25 mg) IVPB 30 minutes weekly (3 weeks on, 1 week off) days 1 and 8. Paclitaxel 80 mg/m2 IVPB 1 hour weekly (2 weeks on, 1 week off) days 1 and 8. Carboplatin AUC 1.5 IVPB 30 minutes days 1 and 8. On Day 15 of each cycle, patients begin the rest week. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Phase II Recommended Dose for the Combination of Temsirolimus + Weekly Paclitaxel + Carboplatin.
기간: 2 years
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2 years
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To Determine the Objective Response Rate (CR or PR) After Two Cycles of Treatment With the Combination of Temsirolimus + Weekly Paclitaxel + Carboplatin as Palliative Therapy for Recurrent or Metastatic HNSCC
기간: 6 weeks
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Evaluation of target lesions: Complete Response - disappearance of all target lesions Partial Response - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter Progressive Disease - at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one of more new lesions Stable Disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started |
6 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
중앙값 전체 생존
기간: 2 년
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2 년
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Number of Participants Who Experienced Adverse Events
기간: 2 years
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Safety will be assessed in terms of AEs according to CTCAE version 3.0
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2 years
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Number of Participants With Potential Molecular Markers of Resistance to mTOR Inhibition
기간: 2 years
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2 years
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 09-131
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. .
Temsirolimus + Weekly Paclitaxel + Carboplatin에 대한 임상 시험
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Wenjun Cheng아직 모집하지 않음조직학적 유형에 따른 신생물 | 부위별 신생물 | 암종 | 신생물, 선상 및 상피 | 생식기 신생물, 여성 | 내분비계 질환 | 난소 질환 | 난소 신생물 | 나팔관 신생물 | 암종, 난소 상피 | 혈관신생 | 생식기 질환, 여성 | 항종양제 | 안로티닙 | 티로신 키나제 억제제
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Peking UniversityMerck Sharp & Dohme LLC; Cancer Institute and Hospital, Chinese Academy of Medical Sciences 그리고 다른 협력자들모병
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Shanghai Chest Hospital아직 모집하지 않음
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Shanghai Henlius Biotech아직 모집하지 않음