Carfilzomib in Refractory Renal Cell Carcinoma (RCC)
21 de febrero de 2020 actualizado por: M.D. Anderson Cancer Center
Phase II Study of Carfilzomib in Patients With Refractory Renal Cell Carcinoma
The goal of this clinical research study is learn if carfilzomib can help control kidney cancer. The safety of this drug will also be studied.
Carfilzomib is designed to block cancer cells from repairing themselves. If the cancer cells cannot repair themselves, this may cause them to die.
Descripción general del estudio
Descripción detallada
Study Groups and Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive carfilzomib 2 days a week for the first 3 weeks of each 4-week study cycle (Days 1, 2, 8, 9, 15, and 16 of each cycle). Each dose is given by vein over about 30 minutes.
Before you receive the study drug, you will be given dexamethasone to help decrease the risk of side effects during the first cycle. You may ask the study staff for information about how the drugs are given and their risks.
During Cycle 1, you will receive extra fluid (saline) by vein before each dose of study drug. This is part of standard clinical care. This will also be done during Cycle 2, if the study doctor thinks it is needed.
You will remain in the clinic for an extra hour after receiving each dose during Cycle 1 and after the first dose of Cycle 2, to receive additional fluids by vein.
If you have any side effects from the drug, tell the study doctor right away. The study doctor may then lower the dose or keep the dose level the same.
Each study cycle is 4 weeks.
Study Visits:
Weeks 1, 2, and 3 of each cycle:
- Your vital signs and weight will be measured.
- Blood (about 3 teaspoons) will be drawn for routine tests
Every 4 weeks (+/-4 days):
- Your medical history will be recorded.
- You will have a physical exam, including measurement of your vital signs and weight.
- You will be asked about any drugs or treatments you may be receiving and any side effects that you have had.
- Your performance status will be recorded.
- Blood (about 3 teaspoons) will be drawn for routine tests and to check your blood sugar level and your pancreatic function, if the study doctor thinks it is needed. You will be asked to fast (not eat, and drink only water) for at least 8 hours before this blood draw.
Every 8 weeks (+/-7 days):
- You will have an x-ray of chest, CT scan of the chest and abdomen, and MRI scan of the brain to check the status of the disease. If the doctor thinks it is needed, you will also have a bone scan.
- If you can become pregnant, you will have a blood (about 2 teaspoons) pregnancy test.
Length of Study:
You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, intolerable side effects occur, or you are not able to follow study directions.
End-of-Treatment Visit:
About 30 days after your last dose of the study drug:
- You will have a physical exam, including measurement of your vital signs and weight.
- You will be asked about any drugs or treatments you may be receiving and any side effects that you have had.
- Blood (about 3 teaspoons) will be drawn for routine and blood sugar tests.
- You will have an x-ray, CT scan, and MRI scan to check the status of the disease.
Long-Term Follow-up:
After you stop taking the study drug, the study staff will check your health status every 6 months for the rest of your life. The study staff will collect this information by either checking your medical record, emailing you, or calling you on the telephone. Each call should only last about 5 minutes.
This is an investigational study. Carfilzomib is FDA approved and commercially available in treatment of multiple myeloma. The use of carfilzomib in kidney cancer is investigational.
Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
Tipo de estudio
Intervencionista
Inscripción (Actual)
10
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
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Texas
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Houston, Texas, Estados Unidos, 77030
- University of Texas MD Anderson Cancer Center
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Biopsy proven clear cell kidney cancer with metastatic disease. Progressive disease or intolerance to at least one but not more than three (3) prior systemic therapy(ies)
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >/= 20 mm with conventional techniques or as >/= 10 mm with spiral CT scan.
- Age >/= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate hepatic function with serum ALT and AST </= 3.0 times the upper limit of normal and serum direct and total bilirubin </= 1.5 times the upper limit of normal.
- Absolute neutrophil count (ANC) >/= 1.0 × 10^9/L; patients with an ECOG performance status of 2 at study entry must have an ANC >/= 1.5 x 10^9/L
- Hemoglobin >/= 8 g/dL (80 g/L) within 14 days prior to beginning study treatment (subjects may be receiving red blood cell [RBC] transfusions in accordance with institutional guidelines); Patients with an ECOG performance status of 2 at study entry must have a hemoglobin >/= 9 g/dL (transfusion assistance acceptable)
- Platelet count >/= 50 × 10^9/L; Patients with an ECOG performance status of 2 at study entry must have a platelet count >/= 100 × 10^9/L
- Creatinine clearance (CrCl) >/= 30 mL/minute, either measured or calculated using a standard formula (eg, Cockcroft and Gault)
- Written informed consent in accordance with federal, local, and institutional guidelines.
- Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing and to practice contraception during the study and for a period of 6 weeks after you stop receiving the study drug
- Male subjects must agree to practice contraception during the study and for a period of 6 weeks after you stop receiving the study drug
Exclusion Criteria:
- Brain metastases not controlled with surgery, whole brain radiotherapy, or with stereotactic radiosurgery
- Systemic therapy within two weeks of treatment initiation
- Pregnant or lactating females
- Major surgery within 21 days prior to beginning study treatment
- Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to beginning study treatment
- Known human immunodeficiency virus infection
- Active hepatitis B or C infection
- Unstable angina or myocardial infarction within 4 months prior to beginning study treatment, NYHA Class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker
- Uncontrolled hypertension (defined by BP consistently > 150/100) or uncontrolled diabetes (defined by HbA1c > 8.5) within 14 days prior to beginning study treatment
- Nonhematologic malignancy within the past 2 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas
- Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to beginning study treatment
- Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib)
- Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment
- Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to beginning study treatment
- Any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Carfilzomib
Patients receive Carfilzomib at dose of 20 mg/m2 over 30 minutes by vein infusion on Days 1 and 2 and a dose of 56 mg/m2 over 30 minutes by vein infusion on Days 8, 9, 15, and 16 of each 4 week cycle.
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20 mg/m2 over 30 minutes by vein infusion on Days 1 and 2 and a dose of 56 mg/m2 over 30 minutes by vein infusion on Days 8, 9, 15, and 16 of each 4 week cycle.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Progression Free Survival (PFS) of Carfilzomib Therapy in Participants With Refractory Or Intolerant to Prior Therapy
Periodo de tiempo: The number of months from enrollment to progression of cancer or death, whichever comes first up to 4 months
|
Progression free survival defined as time from enrollment to progression or death, whichever comes first.
Progression defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Any patients who are alive and free of disease at time of analysis censored at date of most recent tumor assessment.
|
The number of months from enrollment to progression of cancer or death, whichever comes first up to 4 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall Response Rate (ORR)
Periodo de tiempo: Participants response was evaluated every 8 weeks from the first dose of carfilzomib until progression od disease (PD), up to 4 months
|
The number of participants had a complete response (CR, complete reduction in tumor burden) or partial response (PR, a reduction in tumor burden of at least 30%) as determined for radiographic imaging such as a CT scan.
Participants who do not have a reduction in tumor burden will either have stable disease (SD) or progressive disease (PD, which is an increase in tumor burden of at least 20%).
The results are based on the best response that each participant achieved while on treatment.
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Participants response was evaluated every 8 weeks from the first dose of carfilzomib until progression od disease (PD), up to 4 months
|
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Overall Survival (OS)
Periodo de tiempo: 15 months
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The number of months from the time of enrollment until death per participant
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15 months
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Safety of Carfilzomib
Periodo de tiempo: 4 months
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Reason for stopping therapy
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4 months
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PFS and ORR as a Function of VHL Mutation Subtype
Periodo de tiempo: No data collected
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No data collected
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de octubre de 2013
Finalización primaria (Actual)
18 de enero de 2019
Finalización del estudio (Actual)
18 de enero de 2019
Fechas de registro del estudio
Enviado por primera vez
23 de enero de 2013
Primero enviado que cumplió con los criterios de control de calidad
24 de enero de 2013
Publicado por primera vez (Estimar)
25 de enero de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de marzo de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
21 de febrero de 2020
Última verificación
1 de febrero de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2012-0694
- NCI-2013-02350 (Identificador de registro: NCI CTRP)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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