Tirapazamine, Carboplatin, and Paclitaxel in Treating Patients With Advanced Malignant Solid Tumors
Phase I Dose Escalation Study of Tirapazamine (NSC 130181) in Combination With Carboplatin and Paclitaxel in Advanced Malignant 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 tirapazamine, carboplatin, and paclitaxel in treating patients who have advanced malignant solid tumors.
調査の概要
詳細な説明
OBJECTIVES:
- Determine the maximum tolerated dose of tirapazamine in combination with carboplatin and paclitaxel in patients with advanced solid tumors who have or have not received prior chemotherapy.
- Assess the toxicity and preliminary efficacy of this regimen in these patients.
- Determine the pharmacokinetic profile of this regimen in these patients.
- Investigate potential predictors of response by studying patient tissue specimens after receiving this regimen.
OUTLINE: This is a dose-escalation study of tirapazamine. Patients are stratified according to prior chemotherapy status (previously untreated vs previously treated).
Patients receive tirapazamine IV over 2 hours, paclitaxel IV over 3 hours, and carboplatin IV over 30 minutes. Treatment continues every 21 days for a maximum of 8 courses in the absence of unacceptable toxicity or disease progression. Some patients may continue therapy in the absence of unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tirapazamine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. An additional 12 patients in the previously untreated stratum are treated at the MTD.
Patients are followed indefinitely.
PROJECTED ACCRUAL: A total of 36-68 patients (18-34 per stratum) will be accrued for this study within 12-18 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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California
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Duarte、California、アメリカ、91010-3000
- City of Hope Medical Center
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Los Angeles、California、アメリカ、90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Pasadena、California、アメリカ、91105
- City of Hope Medical Group
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Sacramento、California、アメリカ、95817
- University of California Davis 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 or cytologically confirmed advanced or metastatic malignant solid tumor not curable by resection or other standard therapy
No symptomatic brain metastases
- Brain metastases allowed provided controlled with surgical excision and/or radiotherapy
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 3 months
Hematopoietic:
- WBC at least 3,000/mm3
- Absolute neutrophil count at least 1,000/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 2 times upper limit of normal
Renal:
- Creatinine normal
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No New York Heart Association class III or IV congestive heart failure
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study
- No history of allergic reactions to appropriate diuretics or antiemetics administered in conjunction with protocol chemotherapy (e.g., 5-HT3 antagonists)
- No other concurrent uncontrolled illness that would preclude study therapy
- No medical, social, or psychological factors that would preclude study therapy
- No clinically significant hearing loss
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered
- No more than 2 prior chemotherapy regimens
- No prior combination paclitaxel and carboplatin
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- Recovered from prior surgery
Other:
- At least 30 days since other prior investigational drugs
- No other concurrent anticancer therapy
- No other concurrent investigational agents
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
捜査官
- 主任研究者:Stephen Shibata, MD、City of Hope Medical Center
出版物と役立つリンク
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
- 99139
- P30CA033572 (米国 NIH グラント/契約)
- U01CA062505 (米国 NIH グラント/契約)
- CHNMC-PHI-22
- CHNMC-IRB-99139
- NCI-T99-0068
- CDR0000067685 (レジストリ識別子:NCI PDQ)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
カルボプラチンの臨床試験
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Virginia Commonwealth UniversityNational Cancer Institute (NCI)引きこもったステージ IIIA 非小細胞肺がん | ステージ IIIB 非小細胞肺がん | 扁平上皮肺がん | 肺の腺癌 | 大細胞肺がん | ステージ IIA 非小細胞肺がん | ステージ IIB 非小細胞肺がん
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Children's Oncology GroupNational Cancer Institute (NCI)完了脳腫瘍 | 中枢神経系腫瘍アメリカ, カナダ, オーストラリア, スイス, オランダ, ニュージーランド