BMS-214662 Plus Trastuzumab in Treating Patients With Advanced Solid Tumors
Phase I Study of Intravenous BMS-214662 FTI (NSC# 710086) and Herceptin (NSC# 688097) Weekly in Patients With Advanced Malignancies
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose and recommended phase II dose of BMS-214662 when combined with trastuzumab (Herceptin) in patients with advanced solid tumors.
II. Determine the dose-limiting toxic effects of this regimen in these patients.
SECONDARY OBJECTIVES:
I. Determine the pharmacokinetics of this regimen in these patients. Ii. Determine, in a preliminary manner, the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of BMS-214662.
Patients receive BMS-214662 IV over 1 hour on days 2, 8, 15, and 22 and trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of BMS-214662 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive treatment with BMS-214662 and trastuzumab at the recommended phase II dose.
PROJECTED ACCRUAL: A total of 3-28 patients will be accrued for this study.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19111-2497
- Fox Chase Cancer Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Histologically or cytologically confirmed solid tumor that is unresponsive to currently available therapies or for which no known effective therapy exists
- Overexpressing HER-2-neu (2+ or 3+) by immunohistochemistry or fluorescent in situ hybridization
- Clinically or radiologically evaluable disease
No carcinomatous meningitis or untreated/uncontrolled metastatic brain parenchymal disease
- At least 8 weeks since prior therapy for prior brain parenchymal disease and asymptomatic off corticosteroids
- Performance status - ECOG 0-2
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.8 mg/dL
- ALT and AST no greater than 1.5 times upper limit of normal (ULN)
- Creatinine no greater than 1.5 times ULN
- No uncontrolled or significant cardiovascular disease
- No myocardial infarction within the past 6 months
- No prior clinically significant atrial or ventricular arrhythmias
- No prior second or third degree heart block
- No ischemic heart disease requiring medication
- No congestive heart failure
- Corrected QT interval no greater than 450 milliseconds by electrocardiogram
- Ejection fraction at least lower limit of normal by MUGA scan
- No uncontrolled or significant pulmonary disease
- No active unresolved infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study
- At least 4 weeks since prior immunotherapy, including trastuzumab (Herceptin), and recovered
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- No anthracyclines for at least 22 weeks after completion of study therapy
- No other concurrent chemotherapy
- Concurrent hormone replacement therapy allowed
- No other concurrent hormonal therapy
- At least 4 weeks since prior radiotherapy and recovered
- No prior radiotherapy to more than 25% of the bone marrow-containing skeleton
- No concurrent radiotherapy
- At least 4 weeks since prior investigational agents and recovered
- At least 7 days since prior known substrates of cytochrome P450-3A4 (CYP3A4)
- At least 7 days since prior parenteral antibiotics
- No concurrent substrates of CYP3A4
- No concurrent parenteral antibiotics
- No other concurrent experimental medications
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Treatment (BMS-214662, trastuzumab)
Patients receive BMS-214662 IV over 1 hour on days 2, 8, 15, and 22 and trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
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Korrelative studier
Andre navn:
Gitt IV
Andre navn:
Gitt IV
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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MTD defined as the highest dose level at which =< 1/6 subjects experience a study related dose-limiting toxicity (DLT) as assessed by CTC version 2.0
Tidsramme: 28 days
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28 days
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Mary Cianfrocca, Fox Chase Cancer Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NCI-2012-02396
- FCCC-01013
- CDR0000068828 (Registeridentifikator: PDQ (Physician Data Query))
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