- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00741988
Ixabepilone and Carboplatin +/- Bevacizumab in Advanced Non-Small-Cell Lung Cancer
Phase II Trial of Ixabepilone and Carboplatin With or Without Bevacizumab in Patients With Previously Untreated Advanced Non-Small-Cell Lung Cancer
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The trial will include a lead-in phase for each cohort to assess safety. In Cohort A, 10 patients will receive ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle. If no unexpected toxicities occur, Cohort A will open to enrollment. Enrollment for Cohort A will be done in two stages (after the lead-in portion is completed). The first stage for Cohort A will enroll a total of 22 patients (this will include the 10 patients from the lead-in phase). If there are at least 3 responses during stage 1, enrollment for stage 2 will proceed. For stage 2 of the study, 17 additional patients will be enrolled (for a total of 39 patients in Cohort A). During stage 1 and stage 2, patients in Cohort A will receive treatment with ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of each 21-day treatment cycle. Treatment will continue until disease progression or unacceptable toxicity occurs.
After the lead-in phase for Cohort A is completed, a similar lead-in portion, also consisting of 10 patients, will be done for Cohort B. Patients in Cohort B will receive ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle. If no unexpected toxicities occur in this group, Cohort B will open to enrollment. Enrollment for Cohort B will also be done in two stages (after the lead-in portion is completed). The first stage for Cohort B will enroll a total of 22 patients (this will include the 10 patients from the lead-in phase). If there are at least 3 responses during stage 1, enrollment for stage 2 will proceed. For stage 2 of the study, 17 additional patients will be enrolled (for a total of 39 patients in Cohort B). During stage 1 and stage 2, patients in Cohort B will receive treatment with ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of each 21-day treatment cycle. Treatment will continue until disease progression or unacceptable toxicity occurs.
Unexpected toxicities include any grade 4 hematologic toxicity or grade 3/4 non hematologic toxicity that does not reverse within 7 days in more than 2 patients.
Eligible patients will receive ixabepilone, carboplatin, and bevacizumab (bevacizumab will be administered to patients in Cohort B only) at 21-day intervals. Patients will be re evaluated every 6 weeks using computerized tomography (CT) scans. Response to therapy will be assigned using Response Evaluation Criteria in Solid Tumors (RECIST) (Therasse et al. 2000) (see Section 7). Patients who have objective response or stable disease will continue treatment for 6 cycles, until the time of tumor progression or intolerable treatment-related side effects. Patients in Cohort B without progressive disease will be eligible to receive bevacizumab monotherapy for 6 additional cycles, or until undue toxicity or tumor progression occurs.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Florida
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Fort Myers, Florida, Verenigde Staten, 33901
- Florida Cancer Specialists
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Gainesville, Florida, Verenigde Staten, 32605
- Gainsville Hematology Oncology Associates
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Indiana
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Terre Haute, Indiana, Verenigde Staten, 47802
- Providence Medical Group
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Kentucky
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Louisville, Kentucky, Verenigde Staten, 40207
- Consultants in Blood Disorders and Cancer
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Maryland
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Bethesda, Maryland, Verenigde Staten, 20817
- Center For Cancer And Blood Disorders
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Michigan
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Grand Rapids, Michigan, Verenigde Staten, 49503
- Grand Rapids Clinical Oncology Program
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Missouri
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Kansas City, Missouri, Verenigde Staten, 64132
- Research Medical Center
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Montana
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Great Falls, Montana, Verenigde Staten, 59405
- Dr. Donald Berdeaux
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45242
- Oncology Hematology Care
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South Carolina
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Columbia, South Carolina, Verenigde Staten, 29210
- South Carolina Oncology Associates
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Spartanburg, South Carolina, Verenigde Staten, 29303
- Spartanburg Regional Medical Center
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Tennessee
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Nashville, Tennessee, Verenigde Staten, 37023
- Tennessee Oncology, PLLC
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Virginia
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Newport News, Virginia, Verenigde Staten, 23601
- Peninsula Cancer Institute
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Histologically confirmed non-small-cell bronchogenic carcinoma (squamous carcinoma, adenocarcinoma, or large cell carcinoma). Cytologic specimens obtained by brushings, washings, or needle aspiration of the defined lesion are acceptable. Mixed tumors with small-cell anaplastic elements are not eligible.
- Patients who have newly diagnosed unresectable stage III or IV disease are eligible. Patients with stage III disease should be ineligible for combined modality therapy
- Patients must not have received any prior antineoplastic chemotherapy for metastatic lung cancer prior to study entry.
- Patients who have had previous radiotherapy as definitive therapy for locally advanced non-small-cell are eligible as long as the recurrence is outside the original radiation port. Radiation therapy must have been completed greater than 4 weeks prior to registration.
- Male or female patients >=18 years of age.
- Life expectancy of at least 3 months.
- ECOG performance status of <=1.
- Measurable disease by RECIST criteria (see Section 7).
Laboratory values as follows:
- ANC >=1500/mm3 (7 days prior to treatment);
- Hemoglobin >=8 g/dL;
- Platelets >=100,000 mm3 (7 days prior to treatment)
- Bilirubin <=1 x ULN for institution
- AST/SGOT <=2.5 x ULN or <=5.0 x ULN in patients with liver metastases and
- ALT/SGPT <=2.5 x ULN or <=5.0 x ULN in patients with liver metastases
- Creatinine <=2.0 mg/dL or
- Calculated (measured) GFR >=40 mL/min
- PT/INR and PTT <=1.5 x ULN
- Peripheral neuropathy <= grade 1.
Exclusion Criteria:
- A history of cardiac disease as defined by malignant hypertension, unstable angina, congestive heart failure of > grade 2 per New York Heart Association (NYHA) criteria (see Appendix B), myocardial infarction within the previous 6 months, or symptomatic cardiac arrhythmias.
- Metastatic brain or meningeal tumors.
- Uncontrolled intercurrent illness.
- Chemotherapy, investigational drug therapy, or major surgery ≤ 4 weeks prior to starting study drug, or patients who have not recovered from side effects of previous therapy.
- Patient is <=5 years free of another primary malignancy, except if the other primary malignancy is not currently clinically significant or requiring active intervention, or if the other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ.
Exclusion Criteria for Enrollment on Bevacizumab (Cohort B):
- Patients with squamous cell histology NSCLC.
- Patients who have had a major surgical procedure (not including mediastinoscopy), open biopsy, or significant traumatic injury within 1 month of beginning bevacizumab.
- Patients who have had primary thoracic radiation within 3 months of beginning bevacizumab.
- Fine needle aspiration, core biopsy, mediastinoscopy or other minor surgical procedure within 7 days of beginning bevacizumab.
- Patients receiving thrombolytic therapy within 10 days of starting bevacizumab.
- Patients with serious non-healing wound, ulcer, or bone fracture.
- Patients with evidence of bleeding diathesis or coagulopathy.
- Patients with history of hemoptysis (defined as bright red blood of ½ teaspoon or more per episode) within 3 months prior to study enrollment.
Patients with proteinuria at screening, as demonstrated by either:
- Urine protein : creatinine (UPC) ratio >=1.0 or
- Urine dipstick for protein >=2+ (patients discovered to have >=2+ proteinuria on dipstick at baseline should undergo a 24-hour urine collection, and must demonstrate <1 g of protein in 24 hours to be eligible).
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning bevacizumab.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Cohort A
ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
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ixabepilone 30 mg/m2
Andere namen:
carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
Andere namen:
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Experimenteel: Cohort B
ixabepilone 30 mg/m2, carboplatin AUC = 6 intravenously (IV), and bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
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ixabepilone 30 mg/m2
Andere namen:
carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
Andere namen:
bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
Tijdsspanne: 18 months
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The Percentage of Patients Who Experience an Objective Benefit From Treatment
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18 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Totale overleving (OS), de tijdsduur, in maanden, dat patiënten in leven waren vanaf hun eerste datum van protocolbehandeling tot overlijden
Tijdsspanne: 18 maanden
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18 maanden
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Progression Free Survival, the Length of Time, That Patients Were Alive From Their First Date of Treatment Until Worsening of Their Disease
Tijdsspanne: 18 months
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18 months
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Number of Participants Experiencing Treatment Related Toxicity
Tijdsspanne: 18 months
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Number of participants experiencing Grade 3 and Grade 4 Treatment-related toxicities are reported here.
Toxicities that were occurring >=5% of total patients are listed.
Toxicity was assessed using the Common Terminology Criteria for Adverse Events (CTCAE version 3.0) of the National Cancer Institute.
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18 months
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Medewerkers en onderzoekers
Onderzoekers
- Studie stoel: David R Spigel, MD, Sarah Cannon Research Insititute
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Ziekten van de luchtwegen
- Neoplasmata
- Longziekten
- Neoplasmata per site
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- Carcinoom, bronchogeen
- Bronchiale neoplasmata
- Longneoplasmata
- Carcinoom, niet-kleincellige long
- Fysiologische effecten van medicijnen
- Antineoplastische middelen
- Antineoplastische middelen, immunologisch
- Angiogenese-remmers
- Angiogenese modulerende middelen
- Groei stoffen
- Groeiremmers
- Carboplatine
- Bevacizumab
Andere studie-ID-nummers
- SCRI LUN 179
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Niet-kleincellige longkanker
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National Cancer Centre, SingaporeBeëindigdExtranodaal NK-T-CELL LYMFOMASingapore
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Adelphi Values LLCBlueprint Medicines CorporationVoltooidMastcelleukemie (MCL) | Agressieve systemische mastocytose (ASM) | SM w Assoc Clonal Hema Non-Mast Cell Lineage Disease (SM-AHNMD) | Smeulende systemische mastocytose (SSM) | Indolente systemische mastocytose (ISM) ISM-subgroep volledig gerekruteerdVerenigde Staten
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University of Alabama at BirminghamBeëindigdAnaplastisch grootcellig lymfoom | Angioimmunoblastisch T-cellymfoom | Perifere T-cellymfomen | Volwassen T-celleukemie | Volwassen T-cellymfoom | Perifeer T-cellymfoom niet gespecificeerd | T/Null Cell Systemisch Type | Cutaan t-cellymfoom met nodale / viscerale ziekteVerenigde Staten
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Masonic Cancer Center, University of MinnesotaWervingLymfoom | Folliculair lymfoom | Acute myeloïde leukemie | Multipel myeloom | Myelofibrose | Juveniele myelomonocytaire leukemie | Burkitt lymfoom | Acute lymfatische leukemie | Lymfoblastisch lymfoom | Chronische lymfatische leukemie | Lymfoplasmacytisch lymfoom | Acute leukemie | Mantelcellymfoom | Chronische myelogene... en andere voorwaardenVerenigde Staten
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Roswell Park Cancer InstituteActief, niet wervendAcute myeloïde leukemie | Polycytemie Vera | Myelofibrose | Chronische myelomonocytische leukemie | Waldenström Macroglobulinemie | Acute lymfatische leukemie | Chronische lymfatische leukemie | Secundaire acute myeloïde leukemie | Sikkelcelziekte | Myelodysplastisch syndroom | Plasmacelmyeloom | Chronische... en andere voorwaardenVerenigde Staten
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Masonic Cancer Center, University of MinnesotaBeëindigdFolliculair lymfoom | Myelodysplastische syndromen | Multipel myeloom | Hodgkin lymfoom | Burkitt lymfoom | Acute lymfatische leukemie | Chronische lymfatische leukemie | Lymfoplasmacytisch lymfoom | Acute myeloïde leukemie | Mantelcellymfoom | Chronische myelogene leukemie | Prolymfatische Leukemie | Klein lymfocytisch... en andere voorwaardenVerenigde Staten
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Masonic Cancer Center, University of MinnesotaActief, niet wervendFolliculair lymfoom | Acute myeloïde leukemie | Multipel myeloom | Hodgkin lymfoom | Lymfoplasmacytisch lymfoom | Acute leukemie | Myelodysplastisch syndroom | Chronische myelogene leukemie | Prolymfatische Leukemie | Plasmacelleukemie | Beenmergfalensyndromen | Burkitt-lymfoom | Acute lymfoblastische leukemie... en andere voorwaardenVerenigde Staten
Klinische onderzoeken op Ixabepilone
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Weill Medical College of Cornell UniversityBristol-Myers SquibbVoltooidUitgezaaide borstkankerVerenigde Staten
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R-PharmNational Cancer Institute (NCI); Memorial Sloan Kettering Cancer CenterVoltooidNiet-gespecificeerde volwassen solide tumor, protocolspecifiekVerenigde Staten
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National Cancer Institute (NCI)VoltooidLymfoom | Kanker van de dunne darm | Niet-gespecificeerde volwassen solide tumor, protocolspecifiekVerenigde Staten
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Cedars-Sinai Medical CenterBristol-Myers SquibbBeëindigdUrogenitale neoplasmata | Adenocarcinoom | Carcinoom | Neoplasmata, glandulair en epitheel | Genitale neoplasmata, mannelijk | Prostaatneoplasmata | Prostaat Ziekten | Genitale ziekten, manVerenigde Staten
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Eisai Inc.Voltooid
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R-PharmVoltooidVaste maligniteitenVerenigde Staten
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R-PharmVoltooidKankerVerenigde Staten
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R-PharmVoltooidMaagneoplasmataKorea, republiek van, Taiwan, Japan, Singapore, Hongkong
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R-PharmBeëindigd