CCI-779 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Phase II Trial of CCI-779 in Locally Advanced or Metastatic Pancreatic Cancer
調査の概要
詳細な説明
PRIMARY OBJECTIVES:
I. Determine the overall survival at 6 months in patients with locally advanced or metastatic pancreatic cancer treated with CCI-779.
SECONDARY OBJECTIVES:
I. Determine time to progression, progression-free survival, overall survival, and tumor response rate in patients with measurable disease treated with this drug.
II. Correlate biomarkers of response with clinical response in patients treated with this drug.
III. Determine the safety and toxicity of this drug in these patients.
OUTLINE: This is an open-label study.
Patients receive CCI-779 IV over 30 minutes once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 13 months.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
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Texas
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Houston、Texas、アメリカ、77030
- M D Anderson Cancer Center
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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 adenocarcinoma of the pancreas
- Locally advanced or metastatic disease
- Radiographic evidence of disease
- No known brain metastases
- Performance status - ECOG 0-2
- More than 3 months
- WBC ≥ 3,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
- Creatinine ≤ 1.5 mg/dL
- Creatinine clearance ≥ 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
- Fasting serum cholesterol ≤ 350 mg/dL
- Fasting triglycerides ≤ 400 mg/dL
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No other concurrent uncontrolled illness
- No concurrent prophylactic hematopoietic colony-stimulating factors
- No prior chemotherapy for metastatic pancreatic cancer
More than 2 months since prior adjuvant or neoadjuvant chemoradiotherapy for resected pancreatic cancer
- Must have radiographic evidence of recurrent disease
More than 2 months since prior chemoradiotherapy for locally advanced pancreatic cancer
- Must have radiographic evidence of disease progression
- See Chemotherapy
- See Chemotherapy
- No other concurrent investigational or commercial agents or therapies for the malignancy
- No other concurrent anticancer therapy
- No concurrent combination antiretroviral therapy for HIV-positive patients
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 |
|---|---|
|
実験的：Treatment (temsirolimus)
Patients receive CCI-779 IV over 30 minutes once weekly.
Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
相関研究
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 |
|---|---|---|
|
Overall survival (OS)
時間枠：6 months
|
The method of Thall and Simon will be employed.
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6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall response rate defined as the number of patients who achieved CR or PR divided by the number of patients treated
時間枠：Up to 2 years
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95% confidence interval will be presented
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Up to 2 years
|
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Duration of response
時間枠：From the time of objective response to the time of progressive disease, assessed up to 2 years
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From the time of objective response to the time of progressive disease, assessed up to 2 years
|
|
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Time to progression (TTP)
時間枠：From the time of the study entry to the time of relapse or progression, assessed up to 2 years
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From the time of the study entry to the time of relapse or progression, assessed up to 2 years
|
|
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Systemic and local adverse events assessed using the established National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
時間枠：Up to 2 years
|
Descriptive statistics (mean, standard deviation, median, and range) will be displayed for relevant laboratory parameters.
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Up to 2 years
|
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Levels of PTEN, AKT, and PI3K
時間枠：Up to 2 years
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Expression levels will be correlated with patient survival duration using Cox proportional hazard regression analysis
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Up to 2 years
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Expression and phosphorylation status of p70s6k
時間枠：Up to 7 days
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Descriptive statistics will be applied to report the mean, duration of the effects on p70s6k phosphorylation.
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Up to 7 days
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協力者と研究者
捜査官
- 主任研究者：Henry Xiong、M.D. Anderson Cancer 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
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