Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Nab-Paclitaxel and Bevacizumab Followed By Bevacizumab and Erlotinib in Metastatic Breast Cancer

6 novembre 2018 aggiornato da: Jennifer Specht, University of Washington

Combined Targeted Therapies for Triple Negative Advanced Breast Cancer - A Phase II Trial of Weekly Nab-Paclitaxel and Bevacizumab Followed by Maintenance Targeted Therapy With Bevacizumab and Erlotinib

This phase II trial studies how well giving paclitaxel albumin-stabilized nanoparticle (Nab-paclitaxel) formulation together with bevacizumab followed by bevacizumab and erlotinib hydrochloride work in treating patients with metastatic breast cancer. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can prevent cancer growth by blocking the ability of cancer cells to grow and spread. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial evaluates a maintenance treatment with erlotinib and bevacizumab after Nab-paclitaxel and bevacizumab which may control cancer growth with biologic therapies.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

PRIMARY OBJECTIVES:

I. Progression free survival.

SECONDARY OBJECTIVES:

I. Response rate.

II. Overall survival.

III. Safety and toxicity.

IV. Exploratory biomarkers will be assessed as potential predictors of response to treatment including: expression of epidermal growth factor receptor (EGFR) and secreted protein acidic and rich in cysteine (SPARC) in the primary tumor and changes in levels of circulating tumor cells (CTCs) and circulating endothelial cells (CECs).

OUTLINE:

INDUCTION THERAPY: Patients receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients achieving complete response, partial response, or stable disease after completion of induction therapy will receive bevacizumab IV over 30-90 minutes once every 14 or 21 days and erlotinib hydrochloride orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up per physician discretion.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

59

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Alaska
      • Anchorage, Alaska, Stati Uniti, 99508
        • Anchorage Oncology Centre
      • Anchorage, Alaska, Stati Uniti, 99508
        • Katmai Oncology Group
      • Anchorage, Alaska, Stati Uniti, 99508
        • Providence Alaska Medical Center
    • Arizona
      • Yuma, Arizona, Stati Uniti, 85364
        • Yuma Cancer Center
    • Idaho
      • Lewiston, Idaho, Stati Uniti, 83501
        • Saint Joseph Regional Medical Center
    • Montana
      • Bozeman, Montana, Stati Uniti, 59715
        • Bozeman Deaconess Hospital
      • Kalispell, Montana, Stati Uniti, 59901
        • Kalispell Regional Medical Center
    • Oregon
      • Bend, Oregon, Stati Uniti, 97701
        • Bend Memorial Clinic
    • Washington
      • Kennewick, Washington, Stati Uniti, 99336
        • Kadlec Clinic Hematology and Oncology
      • Kirkland, Washington, Stati Uniti, 98033
        • Evergreen Hospital Medical Center
      • Mount Vernon, Washington, Stati Uniti, 98273
        • Skagit Valley Hospital Regional Cancer Care Center
      • Redmond, Washington, Stati Uniti, 98052
        • Group Health Cooperative, Redmond
      • Seattle, Washington, Stati Uniti, 98109
        • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
      • Sequim, Washington, Stati Uniti, 98384
        • Olympic Medical Cancer Care Center
      • Spokane, Washington, Stati Uniti, 99208
        • Spokane Valley Cancer Center-Mayfair
      • Tacoma, Washington, Stati Uniti, 98405
        • Multicare Medical Oncology Hematology
      • Wenatchee, Washington, Stati Uniti, 98801
        • Wenatchee Valley Medical Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

  • Have histologically confirmed invasive breast cancer that is estrogen receptor (ER) negative (=< 10%), progesterone receptor (PR) negative (=< 10%) and human epidermal growth factor receptor 2 (HER2) normal (=< 10% of cells) by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH)
  • Be receiving first-line therapy for metastatic disease
  • Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria; X-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; X-rays, scans or other tests for assessment of non-measurable disease must have been performed within 42 days prior to registration
  • OR non-measurable disease only, with rising serum cancer antigen (CA)15-3 or CA 27.29 or carcinoembryonic antigen (CEA) documented by two consecutive measurements taken at least 14 days apart with the most recent measurement being within 42 days prior to registration; the second CA 15-3 or CA 27.29 or CEA value must have at least a 20% increase over the first and for CA 15-3 or CA 27.29 be greater than or equal to 40 units/mL or for CEA be greater than or equal to 4 ng/mL
  • Subjects with brain metastases as their first site of disease recurrence may be eligible if treated by definitive radiation (stereotactic radiosurgery or whole brain) with clinically controlled neurologic symptoms for a period of 21 days prior to study treatment
  • Bilirubin =< 1.5 mg/dL
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis
  • Alkaline phosphatase =< 2.5 X upper limit of normal, unless bone metastasis is present in the absence of liver metastasis
  • Platelets > 100,000 cells/mm^3
  • Hemoglobin > 9.0 g/dL
  • Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
  • Creatinine =< 1.5 mg/dL is recommended; however, institutional norms are acceptable
  • If of childbearing potential must have a negative pregnancy test and use an effective method to avoid pregnancy for the duration of the trial and for at least 6 months after completion of study therapy
  • Pre-existing peripheral neuropathy, if present, must be < grade 2 (per Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
  • Patients must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional standards and federal guidelines

Exclusion Criteria:

  • Recurrent disease within 12 months after completion of adjuvant chemotherapy containing a weekly taxane
  • Central nervous system (CNS) metastases that are symptomatic and/or requiring steroids
  • Pre-existing nephritic syndrome
  • Serious intercurrent medical or psychiatric illness including serious active infection
  • Inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)
  • Any prior history of hypertensive crisis or hypertensive encephalopathy
  • New York Heart Association (NYHA) grade II or greater congestive heart failure
  • History of myocardial infarction or unstable angina within 6 months prior to study enrollment
  • History of stroke or transient ischemic attack within 6 months prior to study enrollment
  • Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
  • Symptomatic peripheral vascular disease
  • Evidence of bleeding diathesis or coagulopathy
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
  • Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
  • Serious, non-healing wound, ulcer, or bone fracture

  • Proteinuria at screening as demonstrated by either:

    • Urine protein:creatinine (UPC) ratio >= 1.0 at screening OR
    • Urine dipstick for proteinuria > 2+ (patients discovered to have > 2+ proteinuria on dipstick urinalysis at baseline must have a UPC ratio done that is < 1.0 to be eligible; if the UPC ratio is >= 1.0 then the patient should undergo a 24-hour urine collection which must demonstrate =< 1 g of protein in 24 hours for the patient to be eligible)
  • Known hypersensitivity to any component of bevacizumab or to nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Tx (chemo, MoAb, and enzyme inhibitor)

INDUCTION THERAPY: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Patients achieving complete response, partial response, or stable disease after completion of induction therapy will receive bevacizumab IV over 30-90 minutes once every 14 or 21 days and erlotinib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity.
Biologico: bevacizumab
Dato IV
Altri nomi:
  • Avastin
  • anticorpo monoclonale umanizzato anti-VEGF
  • anticorpo monoclonale anti-VEGF
  • rhuMAb VEGF
Droga: erlotinib cloridrato
Dato PO
Altri nomi:
  • OSI-774
  • erlotinib
  • CP-358.774
Droga: formulazione di nanoparticelle stabilizzate con albumina di paclitaxel
Dato IV
Altri nomi:
  • ABI-007
  • nab-paclitaxel
  • prendi il paclitaxel
  • paclitaxel legato all'albumina di nanoparticelle

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-free Survival (PFS)
Lasso di tempo: Time from date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause, assessed up to 8 years
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Kaplan-Meier survival curves will be used. A 95% confidence interval for the median PFS will be calculated. A lower bound greater than 8 months would be strong evidence that Nab-Paclitaxel- bevacizumab induction therapy followed by bevacizumab-erlotinib hydrochloride maintenance therapy is superior to paclitaxel and bevacizumab. However, a median PFS of 13 months or greater (regardless of whether the 95% confidence interval for the median extends below 8 months) could also indicate promising results.
Time from date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause, assessed up to 8 years

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival
Lasso di tempo: Time from date of registration to date of death due to any cause, assessed up to 8 years
Kaplan-Meier survival curves will be used.
Time from date of registration to date of death due to any cause, assessed up to 8 years
Percentage of Participants With Response
Lasso di tempo: Up to 8 years
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Up to 8 years
Incidence of Adverse Events as Assessed by National Cancer Institute CTCAE Version 3.0
Lasso di tempo: Up to 30 days after treatment discontinuation
Adverse events that meet severity grade 2 or greater will be collected and reported. The number and percent of subjects reporting adverse events (all, severe or worse, serious and related) will be summarized for all patients, and stratified by center and other subgroups of interest.
Up to 30 days after treatment discontinuation
EGFR and SPARC Expression in the Primary Tumor
Lasso di tempo: Up to 8 years
Up to 8 years
Changes in Levels of Circulating Tumor Cells
Lasso di tempo: Baseline to up to 8 years
Descriptive statistics, such as mean, standard deviation, and range, will be summarized for circulating tumor cells at baseline and last visit.
Baseline to up to 8 years
Changes in Levels of Circulating Endothelial Cells
Lasso di tempo: Baseline to up to 8 years
Descriptive statistics, such as mean and standard deviation, will be summarized for circulating endothelial cells at baseline and last visit.
Baseline to up to 8 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Washington

Collaboratori

National Cancer Institute (NCI)

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

23 aprile 2008

Completamento primario (Effettivo)

5 luglio 2017

Completamento dello studio (Effettivo)

28 settembre 2017

Date di iscrizione allo studio

Primo inviato

12 agosto 2008

Primo inviato che soddisfa i criteri di controllo qualità

12 agosto 2008

Primo Inserito (Stima)

13 agosto 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 dicembre 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 novembre 2018

Ultimo verificato

1 novembre 2018

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 6628 (Fred Hutchinson Cancer Research Center/UW Consortium)
  • P30CA015704 (Sovvenzione/contratto NIH degli Stati Uniti)
  • NCI-2010-00041 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Cancro al seno in stadio IV

Prove cliniche su bevacizumab

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Rwanda

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi