- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00055861
Bevacizumab and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer
PHASE 2 STUDY OF BEVACIZUMAB IN COMBINATION WITH DOCETAXEL IN PATIENTS WITH ADVANCED BREAST CANCER
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
PRIMARY OBJECTIVES:
I. Determine the response rate in women with locally advanced or metastatic breast cancer treated with bevacizumab and docetaxel.
II. Determine the side effects of this regimen in these patients. III. Correlate soluble activated endothelial cell markers and adhesion molecules, quantitation of tumor and/or endothelial cell apoptosis, and quantitation of microvessel density with clinical outcome in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive bevacizumab IV over 30-90 minutes on weeks 1 and 3 and docetaxel IV over 60 minutes on weeks 1, 2, and 3. Treatment repeats every 4 weeks for up to 12 courses in the absence of unacceptable toxicity or disease progression. After completion of 6 courses of combined treatment, patients with an ongoing response may receive bevacizumab alone in the absence of disease progression.
PROJECTED ACCRUAL: A total of 16-27 patients will be accrued for this study within 14-27 months.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
-
-
Colorado
-
Aurora, Colorado, Vereinigte Staaten, 80045
- University of Colorado Cancer Center - Anschutz Cancer Pavilion
-
-
Ohio
-
Columbus, Ohio, Vereinigte Staaten, 43210
- Ohio State University Medical Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
Histologically or cytologically confirmed breast cancer
- Local-regional recurrences or metastatic disease
- At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- No history or evidence of CNS disease (e.g., primary brain tumor or any brain metastases)
Hormone receptor status:
- Not specified
- Female
- Performance status - ECOG 0-2
- Performance status - Karnofsky 60-100%
- More than 3 months
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- No bleeding diathesis or coagulopathy
- Bilirubin normal
- AST/ALT no greater than 2.5 times upper limit of normal
- INR less than 1.5 (patients receiving warfarin)
- Creatinine normal
- Creatinine clearance at least 60 mL/min
No baseline proteinuria
- Patients with proteinuria of 1+ or greater at baseline are allowed provided 24-hour urinary protein is less than 500 mg
- No symptomatic congestive heart failure
- No cardiac arrhythmia
- No uncontrolled hypertension
- No history of stroke
- No clinically significant peripheral artery disease
No arterial thromboembolic event within the past 6 months, including any of the following:
- Transient ischemic attack
- Cerebrovascular accident
- Unstable angina
- Myocardial infarction
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No seizures not controlled with standard medical therapy
- No prior allergic reactions attributed to compounds of similar chemical or biological composition to study agents
- No psychiatric illness or social situation that would preclude study compliance
- No ongoing or active infection
- No other concurrent uncontrolled illness
- No non-healing wounds
- No significant traumatic injury within the past 28 days
Prior adjuvant chemotherapy allowed (up to 1 regimen for metastatic disease)
- More than 6 months since prior taxane-containing adjuvant chemotherapy
- More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- More than 3 weeks since prior radiotherapy
- More than 28 days since prior major surgery or open biopsy
- More than 7 days since prior fine needle aspirations other than in the breast
- More than 7 days since prior placement of a vascular access device
- No concurrent major surgical procedure
- No concurrent or recent full-dose oral or parenteral anticoagulants or thrombolytic agents (except as required to maintain patency of preexisting, permanent indwelling IV catheters)
- No other concurrent investigational agents
- No concurrent chronic daily aspirin (more than 325 mg/day) or nonsteroidal anti-inflammatory medications (known to inhibit platelet function at doses used to treat chronic inflammatory diseases)
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 (bevacizumab, docetaxel)
Patients receive bevacizumab IV over 30-90 minutes on weeks 1 and 3 and docetaxel IV over 60 minutes on weeks 1, 2, and 3. Treatment repeats every 4 weeks for up to 12 courses in the absence of unacceptable toxicity or disease progression.
|
Korrelative Studien
Gegeben IV
Andere Namen:
Gegeben IV
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST)
Zeitfenster: Up to 4 years
|
The response rate will be estimated with exact binomial 95% confidence intervals.
|
Up to 4 years
|
Side effects as assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 2.0
Zeitfenster: Up to 4 years
|
Up to 4 years
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Correlation of biologic studies with clinical outcomes
Zeitfenster: Up to 4 years
|
Associations between laboratory endpoints (pre-study plasma VEGF and IL-8, E-selectin, P-selectin, CD31, ICAM-1, VCAM_1, CD44, PDGF, FGF, MMP-2 and MMP-9.) and response or toxicity will be investigated using Wilcoxon rank-sum tests for ordinal or continuous endpoints, or chi-square tests for binary or categorical endpoints.
|
Up to 4 years
|
Mitarbeiter und Ermittler
Sponsor
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
- Hautkrankheiten
- Neubildungen
- Neubildungen nach Standort
- Brusterkrankungen
- Neoplasien der Brust
- 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-2012-01433
- OSU 0218
- NCI-2715
- OSU-0218
- UCHSC-01239
- CDR0000271359
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 .
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