- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00049244
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.
Přehled studie
Detailní popis
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.
Typ studie
Fáze
- Fáze 1
Kontakty a umístění
Studijní místa
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California
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Los Angeles, California, Spojené státy, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Linnea Chap, MD, Jonsson Comprehensive Cancer Center
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- BMS-CA163-031
- UCLA-0206011
- CDR0000258052 (Identifikátor registru: PDQ (Physician Data Query))
- NCI-G02-2120
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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