A Study of Temsirolimus Plus Capecitabine in Patients With Advanced Cancer
A Phase I Study of the mTOR Inhibitor Temsirolimus Plus Capecitabine in Patients With Advanced Malignancies
This study is for people with advanced cancer for which no curative treatment exists.
The purpose of this study is to test the safety and effectiveness of the combination of the drugs Temsirolimus and Capecitabine and see what effects it has on cancer.
Temsirolimus is a drug that is given by vein that targets a protein important for the growth of cancer cells known as mTOR. By inhibiting this protein, Temsirolimus can inhibit cancer cell growth and even lead to their death.
Capecitabine is a more traditional chemotherapy. It is an oral pill that gets converted in the body to the very common chemotherapy known as 5-fluorouracil.
This research is being done because it is not known if the combination of Temsirolimus and Capecitabine will work better than Capecitabine or Temsirolimus alone.
연구 개요
상세 설명
This is a Phase I study designed to assess the safety and clinical activity of temsirolimus in combination with capecitabine in patients with advanced malignancies. Because the toxicities of capecitabine are well established, and based on a previous clinical trial of temsirolimus and continuous infusion 5-fluorouracil, an alternating dose escalation plan will be employed.
The first stage of the study will be performed to identify the maximally tolerated dose of the combination, when capecitabine is given on a every 2 week schedule. The starting dose of temsirolimus will be 15-mg IV on day 1 and 8 plus capecitabine 1000 mg/m2 by mouth twice a day on days 1-7 of a 14 day schedule. Patients will be enrolled in a standard 3+3 dose escalating fashion to a maximum dose of temsirolimus of 25-mg and a maximum dose of capecitabine of 1750 mg/m2 twice a day.
If the maximally tolerated dose is determined for the every 2 week schedule, then in the second stage of the study a similar dose escalation plan will be employed for an every 3 week schedule.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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District of Columbia
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Washington, District of Columbia, 미국, 20057
- Georgetown University Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Histologically proven adenocarcinoma with measurable or evaluable disease
- Disease for which capecitabine is approved or compendia listed
- Advanced unresectable, and/or metastatic disease for which there is no known curative therapy
- Performance status 0-2
- Adequate hepatic, bone marrow, and renal function
Exclusion Criteria:
- Brain metastases not under control for at least 3 months
- Active severe infection or known chronic infection with HIV, hepatitis B virus, or hepatitis C virus
- Cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months
- Life-threatening visceral disease or other severe concurrent disease
- Women who are pregnant or breastfeeding
- Anticipated patient survival under 3 months
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: temsirolimus and capecitabine
Treatment with the combination of temsirolimus and capecitabine
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temsirolimus in escalating doses starting at 15-mg IV on days 1 and 8 of a 14 day cycle capecitabine in escalating doses starting at 1000 mg/m2 by mouth twice a day on days 1-7 of a 14-day cycle
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Identification of the recommended Phase II dose of temsirolimus to be used in combination with capecitabine in patients with advanced malignancies
기간: 1 year
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1 year
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Evaluation of toxicity of the combination of temsirolimus plus capecitabine in patients with advanced malignancies as determined by adverse events observed and lab values
기간: 1 year
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1 year
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To determine the response by radiology scans to temsirolimus and 5-FU-based therapies in patients with advanced malignancies
기간: 9 weeks
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9 weeks
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Comparison of the response rate in patients whose tumors demonstrate activation of the mTOR pathway versus those that do not
기간: 9 weeks
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9 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Michael J Pishvaian, Md, PhD, Georgetown University
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
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