BMS-247550 Plus Capecitabine in Treating Patients With Metastatic Breast Cancer
A Phase I Study of BMS-247550 in Combination With Capecitabine in Patients With Metastatic Breast Cancer Previously Treated With a Taxane and an Anthracycline
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 BMS-247550 with capecitabine in treating patients who have metastatic breast cancer that has not responded to previous chemotherapy with a taxane and an anthracycline.
調査の概要
詳細な説明
OBJECTIVES:
- Determine the maximum tolerated dose of BMS-247550 and capecitabine, on 2 different schedules, in patients with metastatic breast cancer previously treated with a taxane and an anthracycline.
- Determine the safety profile of this regimen in these patients.
- Determine, preliminarily, any antitumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 groups.
- Group I: Patients receive BMS-247550 IV over 3 hours on day 1 and oral capecitabine twice daily on days 1-14.
- Group II: Patients receive BMS-247550 IV over 1 hour on days 1-3 and capecitabine as in group I.
Treatment in both groups repeats every 3 weeks for 2-18 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 6 patients receive escalating doses of BMS-247550 and capecitabine until the maximum tolerated dose (MTD) is determined for each group. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity. Additional patients are treated at the MTD.
Patients are followed for at least 30 days and then every 3 months thereafter.
PROJECTED ACCRUAL: Approximately 34-60 patients will be accrued for this study within 8-12 months.
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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California
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Los Angeles、California、アメリカ、90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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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 breast cancer
- Metastatic disease by radiography or histology
Must have received prior chemotherapy with a taxane and an anthracycline in the adjuvant or metastatic setting
- No more than 2 prior chemotherapy regimens in the metastatic setting
Measurable or evaluable disease
- Bone lesions not measurable
- Primary breast lesions not measurable if assessed only by physical exam
No active brain metastasis
- No cerebral edema by CT scan or MRI
- No progression since prior imaging studies
- No requirement for steroids
- No clinical symptoms of brain metastasis
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Not specified
Menopausal status
- Not specified
Performance status
- ECOG 0-1
Life expectancy
- At least 3 months
Hematopoietic
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9.0 g/dL
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- ALT no greater than 2.5 times ULN
Renal
- Creatinine less than 1.5 times ULN
Cardiovascular
- No uncontrolled or significant cardiovascular disease
- No myocardial infarction within the past year
- No uncontrolled angina within the past year
- No history of congestive heart failure
- No history of atrial or ventricular arrhythmias
- No history of second- or third-degree heart block
- No uncontrolled hypertension
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No hypersensitivity to Cremophor EL or fluorouracil
- No prior intolerance to fluoropyrimidines
- No other serious uncontrolled medical disorder or active infection that would preclude study
- No dementia or altered mental status that would preclude study
- No grade 2 or greater neuropathy (neuromotor or neurosensory)
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Chemotherapy
- Prior immunotherapy allowed
- No concurrent trastuzumab (Herceptin)
- No concurrent immunotherapy
Chemotherapy
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or doxorubicin HCl liposome)
- At least 2 years since prior high-dose chemotherapy with bone marrow transplantation or peripheral blood stem cell support
- No prior epothilone, capecitabine, or continuous-infusion fluorouracil
- No other concurrent chemotherapy
Endocrine therapy
- Prior hormonal therapy allowed
- No concurrent hormonal therapy
- Concurrent hormone replacement therapy allowed
Radiotherapy
- At least 3 weeks since prior radiotherapy
- No prior radiotherapy to more than 25% of the bone marrow
- No concurrent therapeutic radiotherapy
Surgery
- Not specified
Other
- At least 3 weeks since prior investigational cytotoxic agents
No concurrent warfarin for therapeutic anticoagulation
- Low-dose warfarin allowed for implanted ports or indwelling catheters
- No other concurrent experimental anticancer medications
- No other concurrent antitumor therapy
- Concurrent bisphosphonates for palliation of bone metastases allowed if initiated before 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
スポンサー
捜査官
- スタディチェア:Linnea Chap, MD、Jonsson Comprehensive Cancer Center
研究記録日
主要日程の研究
研究開始
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。
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