Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Advanced Breast Cancer
A Pharmacokinetic Interaction Study Of Docetaxel (Taxotere) 75 mg/mIV On The Combination Therapy Doxorubicin (50 mg/m) And Cyclophosphamide (50 mg/m) In The Treatment Of Advanced Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel, doxorubicin, and cyclophosphamide, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them at different times, may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for breast cancer.
PURPOSE: Randomized phase I trial to compare the effectiveness of two regimens of docetaxel combined with doxorubicin and cyclophosphamide in treating women who have advanced breast cancer.
調査の概要
詳細な説明
OBJECTIVES:
Primary
- Determine the pharmacokinetic profile of docetaxel, doxorubicin, and cyclophosphamide in women with advanced breast cancer.
Secondary
- Compare the pharmacokinetic profile of this regimen in these patients vs the historical pharmacokinetic profile of docetaxel.
OUTLINE: This is a randomized, open-label, crossover, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive doxorubicin IV over 15 minutes and cyclophosphamide IV over 15 minutes on day 1 followed by doxorubicin IV over 15 minutes, cyclophosphamide IV over 15 minutes, and docetaxel IV over 1 hour on day 22.
- Arm II: Patients receive doxorubicin IV over 15 minutes, cyclophosphamide IV over 15 minutes, and docetaxel IV over 1 hour on day 1 followed by doxorubicin IV over 15 minutes and cyclophosphamide IV over 15 minutes on day 22.
Treatment in both arms continues in the absence of disease progression or unacceptable toxicity. Patients may receive additional therapy at the discretion of the treating physician.
Patients are followed at 3-4 weeks.
PROJECTED ACCRUAL: A total of 24 patients (12 per treatment arm) will be accrued for this study within 7 months.
研究の種類
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
Ohio
-
Cleveland、Ohio、アメリカ、44106-5055
- Ireland Cancer Center
-
-
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 breast cancer
- Adjuvant setting for high-risk disease allowed
- No symptomatic evidence or history of brain metastases
- No leptomeningeal metastases
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 18 to 69
Sex
- Female
Menopausal status
- Not specified
Performance status
- WHO 0-2 OR
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- Neutrophil count at least 2,000/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin greater than 10 g/dL
Hepatic
- Bilirubin less than upper limit of normal (ULN)
- AST and ALT no greater than 2.5 times ULN (1.5 times ULN if alkaline phosphatase greater than 2.5 times ULN)
- Alkaline phosphatase no greater than 5 times ULN
Renal
- Creatinine normal OR
- Creatinine clearance at least 60 mL/min
Cardiovascular
- LVEF or shortening fraction greater than lower limit of normal by MUGA or echocardiography
- Cardiac function normal
- No congestive heart failure
- No unstable angina pectoris
- No myocardial infarction within the past year
- No uncontrolled hypertension
- No high-risk uncontrolled arrhythmia
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective nonhormonal contraception
- No active uncontrolled infection
- No active peptic ulcer
- No unstable diabetes mellitus
- No other serious illness or medical condition
- No contraindication to corticosteroids
- No pre-existing grade 2 or greater motor or sensory neurotoxicity
- No psychological, social, familial, or geographical reason that would preclude study follow-up
- No history of significant neurologic or psychiatric disorder (e.g., psychotic disorder, dementia, or seizures) that would preclude understanding and giving informed consent
- No other neoplasm within the past 10 years except curatively treated nonmelanoma skin cancer, carcinoma in situ of the cervix, ipsilateral ductal carcinoma in situ of the breast, or lobular carcinoma in situ of the breast
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- At least 6 months since prior anthracycline or taxoid (e.g., paclitaxel or docetaxel) therapy
- No prior cumulative anthracycline dose greater than 240 mg/m^2
Endocrine therapy
- Concurrent corticosteroid treatment allowed provided treatment was initiated more than 6 months before study entry and at a dose of less than 20 mg of methylprednisolone or equivalent
- No concurrent ovarian hormonal replacement therapy
Radiotherapy
- Not specified
Surgery
- More than 2 weeks since prior major surgery
Other
- More than 30 days since prior participation in another clinical trial with any investigational drug or device
- No other concurrent experimental drugs
- No other concurrent systemic anticancer therapy
- No concurrent aminoglycoside antibiotics
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:ランダム化
- マスキング:なし(オープンラベル)
協力者と研究者
捜査官
- 主任研究者:Beth A. Overmoyer, MD, FACP、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
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
- CWRU040314
- CDR0000343609 (レジストリ識別子:PDQ (Physician Data Query))
- CWRU-AVEN-1103
- AVENTIS-XRP6976D/1001
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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。
乳がんの臨床試験
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