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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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California
-
Duarte、California、アメリカ、91010
- City of Hope
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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相関研究
与えられた IV
他の名前：
与えられた IV
他の名前：
与えられた IV
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Toxicities at each dose level, graded using the CTC version 2.0
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Response rate, assessed by standard RECIST criteria
時間枠：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
時間枠：From registration to time of death due to any cause, assessed up to 2 years
|
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
時間枠：Up to 2 years
|
Summarized with Kaplan-Meier plots.
|
Up to 2 years
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協力者と研究者
捜査官
- 主任研究者：Angela Davies、City of Hope Medical Center
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
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