- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00049088
Bortezomib and Docetaxel in Treating Patients With Advanced Solid Tumors
A Phase 1 Study of PS-341 in Combination With Docetaxel in Patients With Advanced Solid Tumors
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
OBJECTIVES:
I. Determine the maximum tolerated dose of bortezomib and docetaxel in patients with advanced solid tumors.
II. Determine the toxicity and tolerability of this regimen in these patients. III. Determine the biologic correlates of proteasome inhibition of bortezomib and determine the effects of this inhibition on the pharmacokinetics of docetaxel in these patients.
IV. Determine the antitumor efficacy of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
For course 1, patients receive docetaxel IV over 1 hour on days 1 and 8 and bortezomib IV over 3-5 seconds on days 9 and 12. Patients then receive 1 week of rest. For course 2 and all subsequent courses, patients receive docetaxel on days 1 and 8 and bortezomib on days 2, 5, 9, and 12. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 2-6 patients receive escalating doses of bortezomib and docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity.
PROJECTED ACCRUAL: A minimum of 24 patients will be accrued for this study.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
-
-
Maryland
-
Baltimore, Maryland, Vereinigte Staaten, 21287-8936
- Johns Hopkins University
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
Histologically confirmed solid tumor for which standard curative or palliative measures do not exist or are no longer effective
- Metastatic or unresectable disease
- No known brain metastases
- Performance status - ECOG 0-2
- Performance status - Karnofsky 50-100%
- More than 12 weeks
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 8 g/dL
- Bilirubin normal
- AST and ALT no greater than 1.5 times upper limit of normal (ULN) and alkaline phosphatase no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 5 times ULN (unless bone-derived) and AST and ALT less than 1.5 times ULN
- Creatinine normal
- 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 3 months after study
- No prior allergic reactions attributed to taxanes (e.g., docetaxel or paclitaxel) or compounds of similar chemical or biological composition
- No prior allergic reactions to compounds similar to bortezomib or other study agents
- No known hypersensitivity to corticosteroids
- No predicted intolerance to regular, repeated administration of corticosteroids (e.g., poorly controlled diabetes or significant osteoporosis/osteopenia)
- No ongoing or active infection
- No other uncontrolled concurrent illness that would preclude study participation
- No psychiatric illness or social situation that would preclude study participation
- No peripheral neuropathy grade 2 or greater
At least 4 weeks since prior chemotherapy (6 weeks for carmustine, nitrosoureas, or mitomycin) and recovered
- No more than 3 courses of mitomycin
Prior taxanes allowed
- At least 6 months since prior docetaxel administered on a weekly schedule
- At least 4 weeks since prior radiotherapy and recovered
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent anticancer agents or therapies (commercial or investigational)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Treatment (docetaxel, bevacizumab)
For course 1, patients receive docetaxel IV over 1 hour on days 1 and 8 and bortezomib IV over 3-5 seconds on days 9 and 12. Patients then receive 1 week of rest.
For course 2 and all subsequent courses, patients receive docetaxel on days 1 and 8 and bortezomib on days 2, 5, 9, and 12. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 2-6 patients receive escalating doses of bortezomib and docetaxel until the maximum tolerated dose (MTD) is determined.
The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity.
|
Korrelative Studien
Gegeben IV
Andere Namen:
Korrelative Studien
Andere Namen:
Gegeben IV
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Maximum-tolerated dose (MTD) based on the incidence of dose-limiting toxicity (DLT) as assessed by the NCI Common Toxicity Criteria (CTC) version 2.0
Zeitfenster: 21 days
|
21 days
|
Toxicity and tolerability as assessed by NCI CTC version 2.0
Zeitfenster: Up to 30 days after completion of study treatment
|
Up to 30 days after completion of study treatment
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Pharmacokinetics of docetaxel
Zeitfenster: At baseline, at 30 and 60 during infusion, at 10 min, 30 min, 1, 3, 7.5, 24, and 48 hours, and at 8 days after completion of docetaxel infusion
|
At baseline, at 30 and 60 during infusion, at 10 min, 30 min, 1, 3, 7.5, 24, and 48 hours, and at 8 days after completion of docetaxel infusion
|
Response rate
Zeitfenster: Up to 30 days after completion of study treatment
|
Up to 30 days after completion of study treatment
|
20S proteasome activity
Zeitfenster: At 1 hour after first PS-341 infusion (week 2, day 2), and at 24 and 48 hours
|
At 1 hour after first PS-341 infusion (week 2, day 2), and at 24 and 48 hours
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Deborah Armstrong, Johns Hopkins University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antineoplastische Mittel
- Immunologische Faktoren
- Tubulin-Modulatoren
- Antimitotische Mittel
- Mitose-Modulatoren
- Angiogenese-Inhibitoren
- Angiogenese-modulierende Mittel
- Wuchsstoffe
- Wachstumshemmer
- Docetaxel
- Antikörper
- Immunglobuline
- Bevacizumab
- Antikörper, monoklonal
- Antineoplastische Mittel, immunologische
Andere Studien-ID-Nummern
- NCI-2012-02508
- U01CA070095 (US NIH Stipendium/Vertrag)
- J0203
- CDR0000257807 (Registrierungskennung: PDQ (Physician Data Query))
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Labor-Biomarker-Analyse
-
Vanderbilt University Medical Center4DMedicalAbgeschlossen
-
Central and North West London NHS Foundation TrustBritish HIV Association (BHIVA)Noch keine RekrutierungHIV-Infektionen | Hepatitis B
-
Duke UniversityZurückgezogenAntikoagulations- und Thrombose-Point-of-Care-Test (AT-POCT)Vereinigte Staaten
-
Columbia UniversityAbgeschlossen
-
McGill University Health Centre/Research Institute...Northwestern UniversityRekrutierungApnoe der FrühgeburtlichkeitKanada
-
Emory UniversityDermatology FoundationBeendetKutaner Lupus erythematodesVereinigte Staaten