SU5416 and Paclitaxel in Treating Patients With Recurrent, Locally Advanced or Metastatic Cancer of the Head and Neck
A Phase I Pharmacokinetic, Pharmacodynamic, and Clinical Study of the Combination of the Angiogenesis Inhibitor SU5416 and Paclitaxel in Recurrent or Metastatic Carcinoma of the Head and Neck
RATIONALE: SU5416 may stop the growth of head and neck cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining SU5416 with chemotherapy may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of SU5416 and paclitaxel in treating patients who have recurrent, locally advanced, or metastatic cancer of the head and neck.
調査の概要
詳細な説明
OBJECTIVES:
- Determine the maximum tolerated dose and safety of SU5416 and paclitaxel in patients with recurrent or metastatic head and neck cancer.
- Determine the antiangiogenesis effect of this combination regimen in these patients.
- Determine the toxicity, pharmacodynamic effects, and pharmacokinetic parameters of this combination.
OUTLINE: This is a dose escalation study.
Patients receive paclitaxel IV over one hour on day 1 and SU5416 IV over one hour on days 1 and 4. Treatment continues weekly in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of paclitaxel and SU5416 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose limiting toxicities.
PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study within 9-15 months.
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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Ohio
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Cleveland、Ohio、アメリカ、44106-5065
- Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive 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
DISEASE CHARACTERISTICS:
- Metastatic or loco-regionally recurrent malignancy of the head and neck (including salivary gland and thyroid) that is incurable by surgery or radiotherapy
- At least two distinct tumor masses OR
- One tumor mass at least 3 cm in diameter
- No brain metastases
- No pulmonary metastases as only site of disease
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- WBC at least 3,500/mm3
- Granulocyte count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin greater than 9.0 g/dL
Hepatic:
- PT and PTT normal OR
- INR ratio less than 1.1
- Bilirubin less than 1.5 mg/dL
- AST and ALT less than 2 times upper limit of normal
Renal:
- Creatinine less than 1.5 mg/dL
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- No New York Heart Association class III or IV heart disease
- No uncompensated coronary artery disease
- No history of myocardial infarction or severe or unstable angina within the past 6 months
- No severe peripheral vascular disease
- No deep venous thrombosis or arterial thrombosis within the past 6 months
- No known hypercoagulable syndrome with predisposition to venous or arterial clots
Pulmonary:
- No pulmonary embolism within the past 6 months
Other:
- No prior cerebral hemorrhage
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 3 weeks since palliative chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
- At least 4 weeks since combined chemoradiotherapy and recovered
- Must be recovered from prior taxanes
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior large field radiotherapy and recovered
Surgery:
- Not specified
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)
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 |
時間枠 |
|---|---|
|
Determine the maximum tolerated dose and safety of SU5416 and paclitaxel.
時間枠:Treatment continues weekly in the absence of disease progression or unacceptable toxicity.
|
Treatment continues weekly in the absence of disease progression or unacceptable toxicity.
|
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 (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
キーワード
- 原発不明の再発転移性扁平上皮頸部がん
- 潜在的な原発性扁平上皮癌を伴う転移性扁平上皮頸部癌
- III期の口腔腺様嚢胞癌
- 唇および口腔の再発性扁平上皮癌
- 再発性口腔がん
- 口腔粘膜表皮癌の再発
- 口腔の再発性腺様嚢胞癌
- 中咽頭の再発性扁平上皮癌
- 中咽頭の再発性リンパ上皮腫
- 上咽頭の再発性扁平上皮癌
- 上咽頭の再発性リンパ上皮腫
- 下咽頭の再発性扁平上皮癌
- 喉頭の再発性扁平上皮癌
- 再発性喉頭疣贅癌
- 副鼻腔および鼻腔の再発扁平上皮癌
- 副鼻腔および鼻腔の再発性神経芽細胞腫
- 再発唾液腺がん
- 甲状腺未分化がん
- 再発性副鼻腔および鼻腔の逆さ乳頭腫
- 再発下咽頭がん
- 甲状腺髄様がん
- 再発甲状腺がん
- ステージ III 濾胞性甲状腺がん
追加の関連 MeSH 用語
その他の研究ID番号
- CWRU1399
- U01CA062502 (米国 NIH グラント/契約)
- P30CA043703 (米国 NIH グラント/契約)
- CWRU-1399
- NCI-T99-0084
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