- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01620190
Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Previously Treated Advanced Non-small Cell Lung Cancer
A Phase II Study of Weekly Abraxane for Patients With Advanced NSCLC With EGFR Mutations or With Durable Response to an EGFR Tyrosine Kinase Inhibitor Following Front Line Therapy With EGFR Tyrosine Kinase Inhibitors
Přehled studie
Postavení
Detailní popis
PRIMARY OBJECTIVES:
I. To evaluate the overall response rate of weekly nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) in patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations following front-line therapy with EGFR tyrosine kinase inhibitors (TKI).
SECONDARY OBJECTIVES:
I. To evaluate the safety profile of weekly nab-paclitaxel in patients with advanced NSCLC with EGFR mutations following front-line therapy with an EGFR TKI.
II. To evaluate the time-to-progression and overall survival.
OUTLINE:
Patients receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks and then every 3 months thereafter.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
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Alaska
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Anchorage, Alaska, Spojené státy, 99508
- Anchorage Oncology Centre
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Anchorage, Alaska, Spojené státy, 99508
- Katmai Oncology Group
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Anchorage, Alaska, Spojené státy, 99508
- Providence Alaska Medical Center
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Montana
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Bozeman, Montana, Spojené státy, 59715
- Bozeman Deaconess Hospital
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Washington
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Kennewick, Washington, Spojené státy, 99336
- Kadlec Clinic Hematology and Oncology
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Mount Vernon, Washington, Spojené státy, 98274
- Skagit Valley Hospital
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Port Angeles, Washington, Spojené státy, 98362
- Olympic Medical Center
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Redmond, Washington, Spojené státy, 98052
- Group Health Cooperative
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Seattle, Washington, Spojené státy, 98109
- Fred Hutch/University of Washington Cancer Consortium
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Spokane, Washington, Spojené státy, 99216
- Spokane Valley Cancer Center-Mission
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Tacoma, Washington, Spojené státy, 98415
- MultiCare Health System
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Wenatchee, Washington, Spojené státy, 98801
- Wenatchee Valley Hospital and Clinics
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Pathologically confirmed non-small cell lung cancer with documented EGFR mutation in tumor deoxyribonucleic acid (DNA) or complete/partial response to first line EGFR tyrosine kinase inhibitors with > or = to 6 months duration of response in patients who do not have a confirmed EGFR mutation
- At least one site of measurable disease as determined by the Investigator, using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- Progressive disease with radiographic evidence of disease progression per investigator assessment during therapy with an EGFR tyrosine kinase inhibitor in the metastatic setting; patients may continue EGFR inhibitor therapy throughout the screening period until the day prior to nab-paclitaxel treatment initiation
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 at the time of informed consent
- Platelet count >= 100,000/uL
- Absolute neutrophil count >= 1,500/uL
- Hemoglobin >= 9 g/dL
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = < 2.5 times upper limit of normal
- Alkaline phosphatase =< 2.5 times upper limit of normal, unless bone metastasis is present in the absence of liver metastasis
- Bilirubin =< 1.5 mg/dL
- Creatinine =< 1.5 mg/dL
- Women of child-bearing potential (WOCP) and sexually active men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry, during treatment and for three months after completing treatment
- Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential
- Life expectancy of > 12 weeks
- Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment
Exclusion Criteria:
- Prior conventional cytotoxic chemotherapy for metastatic or recurrent disease; prior adjuvant, neoadjuvant or chemoradiotherapy for NSCLC is permitted, provided at least 6 months elapsed prior to documented metastatic recurrence
- A single dose of a platinum doublet discontinued due to intolerability without evidence of disease progression is permitted
- Patient is < 5 years free of another primary malignancy, except: a) if the other malignancy is basal cell carcinoma or cervical carcinoma in situ or b) if the other primary malignancy is not considered clinically significant and is requiring no active intervention
- Progressive or symptomatic central nervous system (CNS) metastases; patients with known brain metastasis must have stable disease following treatment with surgery, radiation or both; in addition, they must be off corticosteroids
- Radiotherapy within 7 days of study treatment
- Peripheral neuropathy grade 2 or greater
- Grade III/IV congestive heart failure, as defined by New York Heart Association (NYHA) criteria, or myocardial infarction within 6 months
- Any serious or uncontrolled concomitant disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study
- Patient has known chronic liver disease, e.g. diagnosis of chronic active hepatitis or cirrhosis
- Major surgery within 21 days of study treatment; minor surgery within 2 weeks of study treatment; placement of vascular access device and biopsies allowed and is not considered major or minor surgery
- Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent
- Pregnant or breast feeding females
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Treatment (paclitaxel albumin-stabilized nanoparticle formula)
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Korelační studie
Vzhledem k tomu, IV
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Overall Response Rate (Complete and Partial Response) Defined by RECIST 1.1 Criteria
Časové okno: Assessed every two cycles from date of first study therapy until documented disease progression, date of death, unacceptable toxicity, or withdrawal of patient consent, whichever occurs first, assessed up to 60 weeks.
|
The response rate as the proportion and 95% confidence interval of patients who achieved a complete response or partial response will be calculated.
|
Assessed every two cycles from date of first study therapy until documented disease progression, date of death, unacceptable toxicity, or withdrawal of patient consent, whichever occurs first, assessed up to 60 weeks.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Overall Percentage of Patients Experiencing Toxicity Within a Clinically Significant Category Defined as Neutropenia, Neutropenic Fever, or Neuropathy.
Časové okno: Collected from the time patient received the first dose of study therapy through 30 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 64 weeks.
|
Toxicity rates will be described as percentage of patient who experienced a Grade 3 or higher clinically significant toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
|
Collected from the time patient received the first dose of study therapy through 30 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 64 weeks.
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Overall Survival
Časové okno: Assessed from date of patient consent until date of death from any cause or withdrawal of patient consent, whichever occurs first, assessed up to 305 weeks.
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Will report as median values with their respective 95% confidence intervals will be reported.
Time to event distribution will be estimated using Kaplan-Meier method.
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Assessed from date of patient consent until date of death from any cause or withdrawal of patient consent, whichever occurs first, assessed up to 305 weeks.
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Overall Percentage of Patients Experiencing Grade 3 or Higher Toxicity.
Časové okno: Collected from the time patient received the first dose of study therapy through 30 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 64 weeks.
|
Toxicity rates will be described as percentage of patients experiencing Grade 3 or higher toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
|
Collected from the time patient received the first dose of study therapy through 30 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 64 weeks.
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Time to Progression.
Časové okno: Assessed from date of patient consent until documented disease progression, date of death from any cause, start of new anti-cancer therapy, or withdrawal of patient consent, whichever occurs first, assessed up to 60 weeks.
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Reported as median values with their respective 95% confidence intervals for patients who were assessed.
Time to event distribution will be estimated using the Kaplan-Meier method.
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Assessed from date of patient consent until documented disease progression, date of death from any cause, start of new anti-cancer therapy, or withdrawal of patient consent, whichever occurs first, assessed up to 60 weeks.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Christina Baik, Fred Hutch/University of Washington Cancer Consortium
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Nemoci dýchacích cest
- Novotvary
- Plicní onemocnění
- Novotvary podle místa
- Novotvary dýchacího traktu
- Novotvary hrudníku
- Karcinom, Bronchogenní
- Bronchiální novotvary
- Novotvary plic
- Karcinom, nemalobuněčné plíce
- Molekulární mechanismy farmakologického působení
- Antineoplastická činidla
- Tubulinové modulátory
- Antimitotické látky
- Modulátory mitózy
- Antineoplastické látky, fytogenní
- Paklitaxel
- Paklitaxel vázaný na albumin
Další identifikační čísla studie
- 7755 (Fred Hutch/University of Washington Cancer Consortium)
- P30CA015704 (Grant/smlouva NIH USA)
- NCI-2012-00865 (Identifikátor registru: CTRP (Clinical Trial Reporting Program))
- RG1712044 (Jiný identifikátor: Fred Hutch/University of Washington Cancer Consortium)
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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