Surgery and Intrapleural Docetaxel in Treating Patients With Malignant Pleural Effusion
Phase I Trial of Intrapleural Docetaxel Administered Via an Implantable Catheter in Subjects With a Malignant Pleural Effusion
RATIONALE: Giving drugs, such as docetaxel, directly into the pleura after surgery to drain the pleural effusion may help keep fluid from building up again.
PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of intrapleural docetaxel given after surgery in patients with malignant pleural effusion.
연구 개요
상세 설명
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of intrapleural docetaxel in patients with malignant pleural effusion.
Secondary
- Determine the toxicity profile of this drug in these patients.
- Determine the pharmacokinetics of this drug in plasma and pleural fluid from these patients.
- Determine the response in patients treated with this drug.
OUTLINE: This is a dose-escalation study.
Patients undergo thorascopic surgery to drain the malignant pleural effusion. An intrapleural catheter (Pleurx catheter) is then inserted for subsequent docetaxel instillation. Approximately 24 hours after surgery, patients receive docetaxel intrapleurally over 3 minutes via the Pleurx catheter. The Pleurx catheter is then clamped for 4 hours and the patient is placed in several different positions to ensure uniform distribution of docetaxel throughout the pleural cavity.
Cohorts of 3-6 patients receive escalating doses of intrapleural docetaxel 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.
After completion of study treatment, patients are followed at weeks 1 and 3 and then monthly thereafter.
PROJECTED ACCRUAL: Approximately 8-24 patients will be accrued for this study.
연구 유형
등록 (예상)
단계
- 1단계
연락처 및 위치
연구 장소
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Virginia
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Charlottesville, Virginia, 미국, 22908
- University of Virginia 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 confirmed malignant pleural effusion (MPE)
- Symptomatic disease
Candidate for thoracoscopic surgery for treatment of MPE
- No known or suspected ipsilateral pleurodesis that would preclude surgery
- No bilateral MPEs
- No progressive extrapleural disease that is untreatable and/or resistant to systemic treatment
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 8.0 g/dL
Hepatic
- ALT and/or AST ≤ 1.5 times upper limit of normal (ULN) (if alkaline phosphatase normal) OR
- Alkaline phosphatase ≤ 2.5 times ULN (if ALT and/or AST normal)
- Bilirubin normal
- INR ≤ 1.5
Renal
- Creatinine ≤ 1.8 mg/dL
Other
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment
- No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- No peripheral neuropathy > grade 1
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No concurrent systemic chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
|---|
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Maximum tolerated dose by adverse event evaluation 1 month after treatment
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2차 결과 측정
결과 측정 |
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Pharmacokinetics by serum and pleural fluid analyses through 1 month
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Clinical response by chest x-ray response and survival
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공동 작업자 및 조사자
수사관
- 수석 연구원: David R. Jones, MD, University of Virginia
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 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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