- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Florida
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Fort Myers, Florida, Stati Uniti, 33901
- Florida Cancer Specialists
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Gainesville, Florida, Stati Uniti, 32605
- Gainsville Hematology Oncology Associates
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Indiana
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Terre Haute, Indiana, Stati Uniti, 47802
- Providence Medical Group
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Kentucky
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Louisville, Kentucky, Stati Uniti, 40207
- Consultants in Blood Disorders and Cancer
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Maryland
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Bethesda, Maryland, Stati Uniti, 20817
- Center for Cancer and Blood Disorders
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Michigan
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Grand Rapids, Michigan, Stati Uniti, 49503
- Grand Rapids Clinical Oncology Program
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Missouri
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Kansas City, Missouri, Stati Uniti, 64132
- Research Medical Center
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Montana
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Great Falls, Montana, Stati Uniti, 59405
- Dr. Donald Berdeaux
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45242
- Oncology Hematology Care
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South Carolina
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Columbia, South Carolina, Stati Uniti, 29210
- South Carolina Oncology Associates
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Spartanburg, South Carolina, Stati Uniti, 29303
- Spartanburg Regional Medical Center
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37023
- Tennessee Oncology, PLLC
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Virginia
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Newport News, Virginia, Stati Uniti, 23601
- Peninsula Cancer Institute
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Cohort A
ixabepilone 30 mg/m2 and carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
|
ixabepilone 30 mg/m2
Altri nomi:
carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
Altri nomi:
|
Sperimentale: 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.
|
ixabepilone 30 mg/m2
Altri nomi:
carboplatin AUC = 6 intravenously (IV) on Day 1 of one 21-day treatment cycle.
Altri nomi:
bevacizumab 15 mg/kg on Day 1 of one 21-day treatment cycle.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Sopravvivenza globale (OS), il periodo di tempo, in mesi, in cui i pazienti erano in vita dalla prima data del trattamento protocollare fino alla morte
Lasso di tempo: 18 mesi
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18 mesi
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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
Lasso di tempo: 18 months
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18 months
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Number of Participants Experiencing Treatment Related Toxicity
Lasso di tempo: 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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Collaboratori e investigatori
Investigatori
- Cattedra di studio: David R Spigel, MD, Sarah Cannon Research Insititute
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie delle vie respiratorie
- Neoplasie
- Malattie polmonari
- Neoplasie per sede
- Neoplasie delle vie respiratorie
- Neoplasie toraciche
- Carcinoma, broncogeno
- Neoplasie bronchiali
- Neoplasie polmonari
- Carcinoma, polmone non a piccole cellule
- Effetti fisiologici delle droghe
- Agenti antineoplastici
- Agenti antineoplastici, immunologici
- Inibitori dell'angiogenesi
- Agenti di modulazione dell'angiogenesi
- Sostanze per la crescita
- Inibitori della crescita
- Carboplatino
- Bevacizumab
Altri numeri di identificazione dello studio
- SCRI LUN 179
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 Carcinoma polmonare non a piccole cellule
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National Cancer Institute (NCI)ReclutamentoKita-kyushu Lung Cancer Antigen 1, umanoStati Uniti
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National Cancer Institute (NCI)NCIC Clinical Trials Group; Southwest Oncology Group; Cancer and Leukemia Group BCompletatoCarcinoma a cellule renali a cellule chiare | Cancro a cellule renali in stadio III AJCC v7 | Cancro a cellule renali in stadio II AJCC v7 | Stadio I Renal Cell Cancer AJCC v6 e v7Stati Uniti, Canada, Porto Rico
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National Cancer Institute (NCI)TerminatoCarcinoma a cellule renali a cellule chiare | Carcinoma a cellule renali metastatico | Cancro a cellule renali in stadio III AJCC v7 | Cancro a cellule renali in stadio IV AJCC v7 | Cancro a cellule renali in stadio II AJCC v7 | Stadio I Renal Cell Cancer AJCC v6 e v7Stati Uniti