Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
Phase II Trial of O6Benzylguanine and BCNU in Patients With Colon and Rectal Carcinoma
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 II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic colorectal cancer.
調査の概要
詳細な説明
OBJECTIVES:
- Determine the response rate of patients with metastatic colorectal carcinoma treated with O6-benzylguanine and carmustine.
- Evaluate tumor tissue biochemical and immunohistochemical predictors of response in patients treated with this regimen.
- Correlate carcinoembryonic antigen levels in the peripheral blood with response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive O6-benzylguanine (BG) IV over 1 hour and carmustine IV over 1 hour (beginning 1 hour after completion of BG infusion) on day 1. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 19-36 patients will be accrued for this study within 1.7-3 years.
研究の種類
入学 (実際)
段階
- フェーズ2
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:
- Diagnosis of metastatic colorectal carcinoma
- Bidimensionally measurable disease
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- WBC at least 4,000/mm^3
- Granulocyte count at least 1,500/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin greater than 8 g/dL
Hepatic:
- Bilirubin no greater than 1.2 mg/dL
- AST and ALT less than 2.5 times upper limit of normal (ULN)
- PT no greater than ULN (not on anticoagulation therapy)
Renal:
- Creatinine no greater than 1.5 mg/dL
- Creatine clearance greater than 60 mL/min
Pulmonary:
- DLCO at least 60%
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months after study
- No other concurrent active malignancies
- Prior malignancies presumed to be cured allowed
- No other concurrent uncontrolled severe medical problem that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 6 months since prior adjuvant chemotherapy without disease recurrence
- No more than 1 prior chemotherapy regimen for metastatic disease
Endocrine therapy:
- Not specified
Radiotherapy:
- Prior adjuvant radiotherapy allowed
- No prior radiotherapy to more than 25% of total bone marrow
Surgery:
- Not specified
Other:
- No other prior therapy for advanced disease
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 response rate of patients with metastatic colorectal carcinoma treated with O6-benzylguanine and carmustine.
時間枠:Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity.
|
Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity.
|
協力者と研究者
捜査官
- スタディチェア:Smitha Krishnamurthi, MD、Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
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
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。
大腸がんの臨床試験
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O6-benzylguanineの臨床試験
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Duke UniversitySchering-Plough; Keryx / AOI Pharmaceuticals, Inc.完了
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Duke UniversityNational Institutes of Health (NIH); Keryx / AOI Pharmaceuticals, Inc.完了
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Duke UniversityPharmacia; Keryx / AOI Pharmaceuticals, Inc.完了
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Southwest Oncology GroupNational Cancer Institute (NCI)完了
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Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI)完了
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University of ChicagoNational Cancer Institute (NCI)完了
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)完了
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National Cancer Institute (NCI)完了
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National Cancer Institute (NCI)完了