Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
Single Center Open-Label Non-Comparative Phase I Dose Finding Study Of Weekly Flavopiridol In Combination With Weekly Docetaxel In Patients With Advanced Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining flavopiridol with docetaxel in treating patients who have advanced solid tumors.
調査の概要
詳細な説明
OBJECTIVES:
- Determine the maximum tolerated dose of flavopiridol when administered in combination with 2 different doses of docetaxel in patients with advanced solid tumors.
- Determine the clinical pharmacokinetics of this regimen in these patients.
- Determine, preliminarily, the therapeutic activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of flavopiridol.
Patients receive docetaxel IV over 30 minutes followed at least 4 hours later by flavopiridol IV over 1 hour on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Separate MTDs of flavopiridol are determined when flavopiridol is combined with 2 different doses of docetaxel. A total of 10 patients are treated at each flavopiridol MTD.
Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 6-56 patients will be accrued for this study.
研究の種類
段階
- フェーズ 1
連絡先と場所
研究場所
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New York
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New York、New York、アメリカ、10021
- Memorial Sloan-Kettering 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:
- Histologically confirmed advanced solid tumor that is refractory to standard therapy or for which no standard therapy exists
- Measurable or evaluable disease
- No symptomatic or untreated CNS metastases or primary CNS neoplasm
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 70-100%
Life expectancy
- Not specified
Hematopoietic
- WBC at least 3,500/mm3
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin at least 8 g/dL
Hepatic
- Bilirubin no greater than upper limit of normal (ULN)
- SGOT/SGPT no greater than 2.5 times ULN if alkaline phosphatase no greater than ULN OR
- Alkaline phosphatase no greater than 2.5 times ULN if SGOT/SGPT no greater than ULN
Renal
- Creatinine no greater than 1.5 mg/dL
Cardiovascular
- No history of cardiac arrhythmias
- No congestive heart failure
- No myocardial infarction within the past 6 months
Other
- No concurrent serious or uncontrolled infection
- No diabetes not adequately controlled with medication
- No peripheral neuropathy greater than grade 1
- No known allergy to docetaxel or other medications formulated in Polysorbate 80
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 4 weeks since prior immunotherapy
Chemotherapy
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- Prior taxanes allowed
- No prior flavopiridol
Endocrine therapy
- At least 4 weeks since prior hormonal therapy
Radiotherapy
- At least 4 weeks since prior radiotherapy
Surgery
- Not specified
Other
- Recovered from prior therapy
- No prior enrollment in this study
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
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
追加の関連 MeSH 用語
その他の研究ID番号
- AVENTIS-HMR1275A/1501
- MSKCC-02034
- NCI-G02-2106
- CDR0000256563 (レジストリ識別子：PDQ (Physician Data Query))
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