Rebeccamycin Analog in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
A Phase II Study of Rebeccamycin Analogue NSC 655649 in Patients With Metastatic Colorectal Cancer (IMT Codes 23988, 23989, 23993)
調査の概要
詳細な説明
OBJECTIVES:
I. Determine the objective response rate of patients with metastatic or locally recurrent colorectal cancer treated with rebeccamycin analogue.
II. Determine the toxicity of this regimen in this patient population. III. Determine the effect of this regimen on progression-free and overall survival in these patients.
OUTLINE: This is a multicenter study.
Patients receive rebeccamycin analogue IV once on day 1. Treatment repeats every 21 days for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
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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Georgia
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Atlanta、Georgia、アメリカ、30342
- Atlanta Cancer Care
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New York
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Bronx、New York、アメリカ、10461
- Albert Einstein Comprehensive Cancer Center
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Valhalla、New York、アメリカ、10595
- New York Medical College
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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 metastatic or locally recurrent adenocarcinoma of the colon or rectum
- No curable stage of disease
- At least 1 unidimensionally measurable lesion
- At 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- No tumor lesions in previously irradiated area except clearly measurable lesion documented histologically to be consistent with recurrent tumor in previously irradiated bed within pelvis
The following are considered nonmeasurable disease:
- Bone lesions Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Abdominal masses not confirmed and followed by imaging techniques
- Cystic lesions
- No known brain metastases
PATIENT CHARACTERISTICS:
- Age: 18 and over
- Performance status: ECOG 0-2 OR Karnofsky 60-100%
- Life expectancy: More than 12 weeks
- WBC at least 3,000/mm3
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Bilirubin normal
- AST/ALT no greater than 2.5 times upper limit of normal
- Creatinine normal OR creatinine clearance at least 60 mL/min
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study
- Eligible for placement of a central venous catheter
- No prior allergic reactions attributed to compounds of similar chemical or biologic composition to rebeccamycin analogue
- No other uncontrolled concurrent illness
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
PRIOR CONCURRENT THERAPY:
- No concurrent prophylactic growth factors (e.g., epoetin alfa) except for clinically defined indication (e.g., filgrastim (G-CSF) for febrile neutropenia)
- At least 4 weeks since prior chemotherapy (e.g., fluorouracil, oral fluoropyrimidines, irinotecan, or oxaliplatin) (6 weeks for nitrosoureas or mitomycin)
- No other concurrent chemotherapy
- No concurrent hormones except for clinically defined indication
- At least 4 weeks since prior radiotherapy (including to bony sites, whole pelvis, lung, liver, or spinal cord/brain) and recovered
- No prior total dose of radiotherapy more than 7,000 cGy
- No prior radiotherapy to 40% or more of total bone marrow
- No prior radiotherapy to only site of measurable disease
- No concurrent radiotherapy
- Recovered from prior therapy 1 prior adjuvant treatment allowed 1 prior treatment for advanced disease allowed
- At least 4 weeks since prior investigational agents
- No other concurrent investigational antineoplastic drugs
- No other concurrent investigational agents
- No concurrent commercial agents for colorectal cancer
- No concurrent combination antiretroviral therapy for HIV-positive patients
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 I
Patients receive rebeccamycin analogue IV once on day 1.
Treatment repeats every 21 days for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
|
協力者と研究者
捜査官
- スタディチェア:Sridhar Mani, MD、Albert Einstein College of Medicine
研究記録日
主要日程の研究
研究開始
一次修了 (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
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