Bortezomib Plus Gemcitabine and Carboplatin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
A Phase I Study Of PS-341 In Combination With Gemcitabine And Carbloplatin In Selected Stage IIIB Or IV Non-Small Cell Lung Cancer
연구 개요
상태
상세 설명
PRIMARY OBJECTIVES:
I. Determine the safety and feasibility of combining bortezomib with gemcitabine and carboplatin in patients with advanced or recurrent non-small cell lung cancer.
II. Determine the maximum tolerated dose of bortezomib administered in combination with gemcitabine and carboplatin in these patients.
III. Correlate results from laboratory studies on patient tissue and serum specimens with potential predictors of response in patients treated with this regimen.
IV. Determine, preliminarily, the response of patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of bortezomib.
Patients receive gemcitabine IV over 30 minutes on days 1 and 8, carboplatin IV over 15-30 minutes on day 1, followed 1 hour later by bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with a clinical or radiographic response may continue receiving bortezomib beyond 6 courses.
Cohorts of 3-6 patients receive escalating doses of bortezomib 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. Once the MTD is determined, at least 10 additional patients with chemotherapy-naive disease receive treatment as above with the MTD of bortezomib.
Patients are followed for survival.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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California
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Duarte, California, 미국, 91010
- City of Hope
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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 non-small cell lung cancer
- Selected stage IIIB (malignant pleural effusion) or stage IV disease
- Recurrent disease after first-line therapy allowed
Patients who received prior platinum-based chemotherapy must have no disease progression during or within 3 months after completion of therapy
- Patients who are enrolled at the maximum tolerated dose must have chemotherapy-naïve disease
- Evaluable disease
- Asymptomatic brain metastases allowed if treated with surgical resection or radiotherapy, neurologically stable, and off steroids for at least 4 weeks
- Performance status - Karnofsky 60-100%
- More than 3 months
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 mg/dL
- AST no greater than 2.5 times upper limit of normal
- Creatinine normal
- Creatinine clearance at least 50 mL/min
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No peripheral neuropathy grade 2 or greater
- No prior allergic reactions to compounds of similar chemical or biological composition to bortezomib or other agents used in this study
- No concurrent ongoing or active infection
- No other concurrent uncontrolled illness
- No psychiatric illness or social situation that would preclude study compliance
- No concurrent routine filgrastim (G-CSF)
- See Disease Characteristics
- No more than 1 prior chemotherapy regimen
- At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
- No prior gemcitabine
- See Disease Characteristics
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy and recovered
- See Disease Characteristics
- More than 30 days since prior investigational drugs
- No prior bortezomib
- No concurrent anticonvulsant therapy
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent investigational or commercial agents or therapies with intent to treat malignancy
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 (gemcitabine hydrochloride, carboplatin, bortezomib)
Patients receive gemcitabine IV over 30 minutes on days 1 and 8, carboplatin IV over 15-30 minutes on day 1, followed 1 hour later by bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients with a clinical or radiographic response may continue receiving bortezomib beyond 6 courses.
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상관 연구
주어진 IV
다른 이름들:
주어진 IV
다른 이름들:
주어진 IV
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Toxicities at each dose level, graded using the CTC version 2.0
기간: 18 weeks
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Summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity, (by NCI Common Toxicity Criteria and nadir or maximum values for the laboratory measures, time of onset (i.e.
course number), duration, and reversibility or outcome.
Tables will be created to summarize these toxicities and side effects by dose and course.
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18 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Response rate, assessed by standard RECIST criteria
기간: Up to 2 years
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Summarized by exact binomial confidence intervals.
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Up to 2 years
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Survival
기간: From registration to time of death due to any cause, assessed up to 2 years
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Summarized with Kaplan-Meier plots.
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From registration to time of death due to any cause, assessed up to 2 years
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Time to failure
기간: Up to 2 years
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Summarized with Kaplan-Meier plots.
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Up to 2 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Angela Davies, City of Hope Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 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-2012-02503
- N01CM17101 (미국 NIH 보조금/계약)
- PHI-40
- CDR0000258189 (레지스트리 식별자: PDQ (Physician Data Query))
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