Nab-Paclitaxel, Cisplatin, and Cetuximab With Concurrent Radiation Therapy for Locally Advanced Head and Neck Cancer
A Phase I/II Study of Nab-paclitaxel, Cisplatin and Cetuximab With Concurrent Radiation Therapy for Local-regionally Advanced Head-and-neck Squamous Cell Carcinoma
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Paclitaxel albumin-stabilized nanoparticle formulation may make tumor cells more sensitive to radiation therapy. Giving radiation therapy and paclitaxel albumin-stabilized nanoparticle formulation together with cisplatin and cetuximab may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with cisplatin, cetuximab, and radiation therapy to see how well they work in treating patients with locally advanced stage III or stage IV head and neck cancer.
調査の概要
状態
条件
詳細な説明
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle formulation when combined with cisplatin, cetuximab, and radiotherapy in patients with local-regionally advanced squamous cell carcinoma of the head and neck. (Phase I)
- To evaluate the disease-free survival of patients treated with this regimen. (Phase II)
Secondary
- To identify dose-limiting toxicities in these patients treated with this regimen. (Phase I)
- To assess the safety and tolerability of this regimen. (Phases I and II)
- To assess progression-free survival and survival of patients treated with this regimen. (Phase I)
- To assess overall survival in patients treated with this regimen. (Phase II)
- To assess response rates in patients treated with this regimen. (Phases I and II)
OUTLINE: This is a multicenter, phase I dose-escalation study of paclitaxel albumin-stabilized nanoparticle formulation followed by a phase II study.
Patients receive cetuximab IV over 120 minutes in week 1. Patients then receive cetuximab IV over 60 minutes, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes, and cisplatin IV over 60 minutes once weekly in weeks 2-8. Patients also undergo 3D conformal or intensity-modulated radiotherapy over 30 minutes on days 1-5 in weeks 2-8.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 4 years.
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
-
-
Texas
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Dallas、Texas、アメリカ、75204
- Baylor Research Institute
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Dallas、Texas、アメリカ、75239
- University of Texas Southwestern Medical Center
-
-
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
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma of the oropharynx, hypopharynx, or larynx
- Diagnosis based on the primary lesion and/or lymph nodes
- Stage III or IV disease (T2, N2-3, M0 or T3-4, any N, M0)
- No primary tumor of the oral cavity, nasopharynx, sinuses, or salivary glands
- No distant metastasis by chest x-ray, CT scan, or PET/CT scan within the past 6 weeks
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-1
- ANC > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Hemoglobin > 9.0 g/dL (transfusion or other intervention to achieve hemoglobin > 8.0 g/dL allowed)
- Bilirubin ≤ 1.5 mg/dL
- AST, ALT, and AP ≤ 2.5 times upper limit of normal
- Serum creatinine ≤ 1.5 mg/dL
- Creatinine clearance ≥ 50 mL/min
None of the following electrolyte abnormalities grade 3-4 by CTCAE v 3.0:
- Calcium < 7 mg/dL or > 12.5 mg/dL
- Glucose < 40 mg/dL or > 250 mg/dL
- Magnesium < 0.9 mg/dL or > 3 mg/dL
- Potassium < 3 mmol/L or > 6 mmol/L
- Sodium < 130 mmol/L or > 155 mmol/L
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other prior invasive malignancy, except for nonmelanomatous skin cancer, unless disease-free for ≥ 3 years
- No prior allergic reaction to study drugs
No active cardiac disease, defined as any of the following:
- Unstable angina
- Uncontrolled hypertension
- Myocardial infarction within the past 6 months (unless successfully treated with coronary artery bypass graft or percutaneous transluminal coronary angioplasty)
- Uncontrolled arrhythmia
- Congestive heart failure
- Three or more heart-related hospitalizations within the past year
- No severe chronic obstructive pulmonary disease requiring ≥ 3 hospitalizations within the past year
- No AIDS
- No pre-existing peripheral sensory neuropathy ≥ grade 2
- No concurrent medical illnesses that would impair patient tolerance to therapy or limit survival
PRIOR CONCURRENT THERAPY:
No prior systemic chemotherapy for this cancer
- Prior systemic chemotherapy for a different cancer allowed
- No prior radiotherapy to the region of this cancer that would result in overlap of radiotherapy fields
- No prior initial surgical treatment (excluding diagnostic biopsy of the primary site or nodal sampling of neck disease)
- At least 48 hours since prior and no concurrent granulocytic growth factors (e.g., filgrastim [G-CSF]) during radiotherapy
- No concurrent erythropoietic growth factors (e.g., darbepoetin, erythropoietin)
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:arm one
Nab-Paclitaxel, Cisplatin, Cetuximab, intensity-modulated radiation therapy
|
Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor
Cisplatin is an anti-cancer chemotherapy drug
他の名前:
paclitaxel albumin-stabilized nanoparticle formulation
他の名前:
intensity-modulated radiation therapy
|
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 |
---|---|---|
Phase I Maximum Tolerated Dose of Nab-Paclitaxel
時間枠:90 days
|
Seven participants were assigned nab-paclitaxel in dose of 25mg/m^2.
Five participants were assigned nab-paclitaxel in dose of 20mg/m^2.
|
90 days
|
Phase II 2-year Progression-free Survival
時間枠:2 year
|
Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The primary endpoint of 2-year progression-free survival was measured from the date of enrollment to the first occurrence of new metastatic lesion, objective tumor progression, or death. |
2 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Phase II 2-year Local Control
時間枠:2 year
|
Local control is defined as the arrest cancer growth at the site of origin.
Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions
|
2 year
|
Phase II 2-year Overall Survival
時間枠:2 year
|
median follow-up 24 months for 34 patients
|
2 year
|
協力者と研究者
捜査官
- 主任研究者:Hak Choy, MD、Simmons Cancer Center
研究記録日
主要日程の研究
研究開始 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- STU 072010-046
- SCCC-112008-019
- CDR0000634258
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