- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00035516
A Phase II Study of Epothilone Analog BMS-247550 in Patients With Non-Small Cell Lung Cancer Who Have Failed First Line Platinum Based Chemotherapy
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Alabama
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Birmingham, Alabama, Stati Uniti, 35294
- University of Alabama at Birmingham
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California
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Sacramento, California, Stati Uniti, 958177
- Un of California Davis Cancer Center
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Florida
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Miami Beach, Florida, Stati Uniti, 33140
- Mount Sinai Medical Center
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Tampa, Florida, Stati Uniti, 33612
- H Lee Moffitt Cancer Center
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Illinois
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Chicago, Illinois, Stati Uniti, 60612-3828
- Rush Presbyterian St Lukes ME
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Kentucky
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Louisville, Kentucky, Stati Uniti, 40207
- Consultants in Blood Disorders
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Louisiana
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New Orleans, Louisiana, Stati Uniti, 70121
- Ochsner Cancer Institute
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Maryland
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Baltimore, Maryland, Stati Uniti, 21201
- University of Maryland Greenbaum Cancer Center
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Massachusetts
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Burlington, Massachusetts, Stati Uniti, 01805
- Lahey Clinic
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Missouri
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Columbia, Missouri, Stati Uniti, 65203
- University of Missouri/Ellis Fischel Cancer Center
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New Hampshire
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Lebanon, New Hampshire, Stati Uniti, 03756
- Dartmouth-Hitchcock /Norris Cotton Cancer Center
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New Jersey
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New Brunswick, New Jersey, Stati Uniti, 08901
- Cancer Institute Of New Jersey
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North Carolina
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Chapel Hill, North Carolina, Stati Uniti, 27599
- Unviversity of North Carolina
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37203
- Sarah Cannon Cancer Center
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Nashville, Tennessee, Stati Uniti, 37232-5536
- Vanderbilt University Med School Div of Medical Oncology
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Wisconsin
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Madison, Wisconsin, Stati Uniti, 53792
- University of Wisconsin Hospital
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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 or cytologically confirmed non-small cell lung cancer
- Bidimensionally measurable disease
- Progressed following therapy with one prior cisplatin or carboplatin based chemotherapy regimen for Stage III or IV or metastatic recurrent disease
- Adequate hematologic function as defined by: absolute neutrophils =/> 2,000/mm3, and platelets > 125,000/mm3
- Adequate hepatic function as defined by: serum bilirubin=/<1.5 times the upper institutional limits of normal, ALT =/< 2.5 times the upper institutional limits of normal (=/<5 times the upper institutional limits of normal if hepatic metastases are present
- Adequate renal function as defined: by serum creatine =/< 1.5 times the upper limits of normal
- Adequate recovery from recent surgery, chemotherapy and radiation therapy. At least one week must have elapsed from the time of a minor surgery, at least 3 weeks for major surgery, chemotherapy and radiation therapy
- Life expectancy of at least 12 weeks
- ECOG performance status of 0-1
- At least 18 years old
- Willing and able to give written informed consent
- Accessible for treatment and follow-up. Patients enrolled in this trial must be treated at the participating center
- Women of Child Bearing Potential (WOCP) must have a negative serum or urine pregnancy test (minimum sensitivity IU/L or equivalent units of HCG) within 72 hours prior to start of study medication.
WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea=/>12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35mIU/mL]. Even women who are using oral, implanted or, injectable intrauterine device or barrier methods (diaphragm, condoms, spermicide) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential.
Exclusion Criteria
- More than one prior chemotherapy regimen for Stage IIIB or IV or for metastatic recurrent disease. Prior adjuvant or neoadjuvant chemotherapy is allowed.
- Patients who are candidates for curative resection.
- CTC Grade 2 or greater neuropathy (motor or sensory)
- Known brain metastases
- Prior radiation must have not included major bone marrow containing areas (pelvis, lumbar, spine) and must not have contained a target lesion as the only measurable lesion. A recovery period of at least 3 weeks after completion of radiotherapy is required prior to enrollment.
- Myocardial infarction, unstable angina, or any history of congestive heart failure within six months of study therapy
- Pregnant or breast-feeding women, or sexually active women of childbearing potential not using an adequate method of birth control.
- Sexually active fertile men, whose partners are women of childbearing potential, unless using an adequate method of birth control
- Serious intercurrent infections, or nonmalignant medical illnesses that are controlled or whose control may be jeopardized by the complications of this therapy
- Psychiatric disorders or other conditions rendering the patient incapable of complying with the requirements of the the protocol
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
Collaboratori e investigatori
Sponsor
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 (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
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
- Meccanismi molecolari dell'azione farmacologica
- Agenti antineoplastici
- Modulatori della tubulina
- Agenti antimitotici
- Modulatori della mitosi
- Epotiloni
Altri numeri di identificazione dello studio
- CA163-011
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 .