Bortezomib and Cetuximab in Treating Patients With Advanced Solid Tumors
Phase I Study of Bortezomib (Velcade) and Cetuximab (Erbitux) for Patients With Solid Tumors Expressing EGFR
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving bortezomib together with cetuximab may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with cetuximab in treating patients with advanced solid tumors.
調査の概要
詳細な説明
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of bortezomib when given together with cetuximab in patients with advanced solid tumors expressing epidermal growth factor receptor (EGFR).
Secondary
- To obtain preliminary information about the anti-tumor activity of bortezomib and cetuximab.
OUTLINE: This is a dose-escalation study of bortezomib.
Patients receive bortezomib intravenously (IV) on days 1 and 8 and cetuximab IV over 60-90 minutes on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After the maximum tolerated dose (MTD) is determined, an additional 10 patients are treated at the MTD.
After completion of study treatment, patients are followed periodically for up to 1 year.
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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Minnesota
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Minneapolis、Minnesota、アメリカ、55455
- Masonic Cancer Center at University of Minnesota
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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:
Diagnosis of solid tumor that overexpresses epidermal growth factor receptor (EGFR) including, but not limited to, the following:
- Breast cancer
- Lung cancer
- Colon cancer
- Pancreatic cancer
- Head and neck cancer
- Kidney cancer
- Sarcoma
Advanced disease
- Must have failed or become intolerant to prior standard therapy and is no longer likely to respond to such therapy
- Measurable or nonmeasurable disease
- ECOG performance status 0-1
- ANC ≥ 1,500/mm³
- Platelet count > 100,000/mm³
- Hemoglobin > 9 g/dL
- Bilirubin < 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase < 3.0 times ULN (5.0 times ULN if liver has tumor involvement)
- Aspartate aminotransferase (AST) and alanine aminotransferase (*ALT) < 3.0 times upper limit of normal (ULN) (5.0 times ULN if liver has tumor involvement)
- Creatinine clearance > 30 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- Recovered from all prior therapy
- Prior systemic chemotherapy, immunotherapy, or biological therapy allowed
- At least 14 days since prior radiotherapy or systemic therapy
- At least 30 days since prior investigational agents
- At least 14 days since other prior investigational drugs (for reasons other than the treatment of cancer)
Exclusion Criteria:
- Untreated or symptomatic central nervous system (CNS) metastases
- Concurrent serious systemic disorders (e.g., active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study
- Uncontrolled diabetes
- Myocardial infarction within the past 6 months
- New York Heart Association (NYHA) class III or IV heart failure
- Uncontrolled angina
- Severe uncontrolled ventricular arrhythmias
- Evidence of acute ischemia or active conduction system abnormalities by ECG
- Peripheral neuropathy Common Terminology Criteria for Adverse Events (CTCAE) grade > 2
- Known hypersensitivity to bortezomib, boron, or mannitol
- Serious medical or psychiatric illness likely to interfere with study participation
- Prior bortezomib and/or cetuximab
- Concurrent filgrastim (G-CSF) or other hematologic support during course 1 of study treatment
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：非ランダム化
- 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：Bortezomib and Cetuximab
The starting dose of bortezomib will be 1.3 mg/m2 with a 0.1 increment increase with each successive dose level to a maximum of 2.0 mg/m2.
A loading dose of cetuximab will be given on day 1 (400 mg/m2) followed by a weekly dose of 250 mg/m2.
|
A loading dose of cetuximab will be given on day 1 (400 mg/m2) followed by a weekly dose of 250 mg/m2.
他の名前：
The starting dose of bortezomib will be 1.3 mg/m2 with a 0.1 increment increase with each successive dose level to a maximum of 2.0 mg/m2.
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 |
|---|---|---|
|
Maximum tolerated dose (MTD) of bortezomib
時間枠：At end of Cycle 1 (Week 3)
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The standard Phase I design will be used to determine the maximum tolerated dose of bortezomib when given with weekly cetuximab.
The MTD is defined as the highest dose studied for which the incidence of dose limiting toxicity (DLT) was less than 33%.
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At end of Cycle 1 (Week 3)
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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 |
|---|---|---|
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Disease response as measured by RECIST criteria
時間枠：At Week 4
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The best overall response is the best response recorded from registration until disease progression/recurrence, taking as reference for progressive disease the smallest measurements recorded since registration.
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At Week 4
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協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (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 (実際)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- CDR0000586671
- UMN-2005LS037 (その他の識別子：CPRC, University of Minnesota)
- MILLENNIUM-X05160 (その他の識別子：Millennium Pharm Inc.)
- UMN-0506M7030372 (その他の識別子：IRB, University of Minnesota)
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