- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00459342
Dasatinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Phase II Study of Dasatinib in Non Small Cell Lung Cancer
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
PRIMARY OBJECTIVES:
I. Determine the progression-free survival at 12 weeks in patients with stage IIIB or IV or recurrent non-small cell lung cancer treated with dasatinib.
SECONDARY OBJECTIVES:
I. Determine the rate of response in patients treated with this drug. II. Examine the relationship between clinical response to this drug and epidermal growth factor receptor (EGFR) mutational status, EGFR copy number, and (phosphorylated Src) pSrc expression levels in pre-treatment tumor biopsies.
III. Determine the toxicity of this drug.
OUTLINE:
Patients received oral dasatinib twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Previously obtained paraffin-embedded tumor tissue samples are analyzed by polymerase chain reaction and fluorescent in situ hybridization (FISH) for epidermal growth factor receptor and by immunohistochemistry for pSrc expression.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Texas
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Houston, Texas, Stati Uniti, 77030
- M D Anderson Cancer Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Platelet count >= 100,000/mm^3
Histologically or cytologically confirmed non-small cell lung cancer meeting 1 of the following criteria:
- Stage IV disease
- Stage IIIB disease with pleural effusion
- Recurrent disease after surgery or radiotherapy
- Measurable disease, defined as >= 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
- Previously treated brain metastasis allowed, provided there is no bleeding, no midline shift, no need for steroids or anti-convulsants, and no symptoms
- Must agree to obtain residual tumor tissue available from the existing diagnostic biopsy tumor tissue
- Eastern cooperative oncology group (ECOG) performance status (PS) 0-1 OR Karnofsky PS 60-100%
- Life expectancy > 12 weeks
- White blood cell (WBC) >= 3,000/mm^3
- Absolute neutrophil count >= 1,500/mm^3
- Bilirubin =< 1.5 times upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and ALT =< 2.5 times ULN
- Creatinine =< 3 times ULN OR Creatinine clearance >= 60 mL/min
- No uncontrolled congestive heart failure or potentially life-threatening arrhythmia
- No angina at rest
- No neuropathy >= grade 2
- No chronic diarrhea or history of inflammatory bowel disease
- No history of pulmonary fibrosis (other than in an irradiated field)
- No other concurrent serious medical illness
- O2 saturation > 92% on room air
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of allergic reactions to compounds of similar chemical or biological composition to dasatinib
- No heart rate-corrected QT interval (QTc) prolongation (i.e., QTC >= 480 msec) or other significant ECG abnormalities that could lead to adverse effects if the QTc interval were prolonged
No medical condition that impairs the ability to swallow, retain, or absorb dasatinib including, but not limited to, any of the following:
- Gastrointestinal tract disease resulting in an inability to take oral medication, requirement for IV alimentation, prior surgical procedures affecting absorption, active peptic ulcer disease
- No myocardial infarction or ventricular tachyarrhythmia within the past 6 months
- left ventricular ejection fraction (LVEF) normal
- No major conduction abnormality (unless cardiac pacemaker is present)
- No ongoing or active infection
- No history of significant bleeding disorder (congenital [von Willebrand's disease] or acquired [antifactor VIII antibodies])
- No psychiatric illness or social situation that would preclude study compliance
- No prior chemotherapy or biologic therapy for recurrent or metastatic non-small cell lung cancer
- Adjuvant cytotoxic chemotherapy after surgical resection or chemotherapy with radiation for locally advanced disease (curative intent) allowed provided disease recurrence >= 3 months after completion of last chemotherapy dose
- Measurable disease must be outside the radiotherapy port OR clearly growing inside the port
- No prior radiotherapy to >= 25% of the marrow-containing skeleton
- At least 7 days since prior and no concurrent medications that are inhibitors or inducers of CYP3A4
- At least 7 days since prior and no concurrent agents with proarrhythmic potential
- No other concurrent investigational agents
- No other concurrent anticancer agents or therapies
- No concurrent antiretroviral therapy for HIV-positive patients
- No concurrent systemic antacids (H2 receptor antagonists and proton pump inhibitors)
- Locally acting antacids allowed except for 2 hours before and after dasatinib administration
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Arm I
Patients received oral dasatinib twice daily on days 1-21.
Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
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Dato oralmente
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Number of Participants With Objective Response (Complete Response (CR) or Partial Response (PR))
Lasso di tempo: 12 weeks
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Objective response defined as participants with Complete Response (CR) or Partial Response (PR) evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
RECIST definitions are Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Response measured by tumor size on computed tomography scans and by metabolic activity on positron emission tomography scans.
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12 weeks
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Progression-free Survival (PFS)
Lasso di tempo: Time from start of treatment to time of progression or death, assessed at 2 months
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Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death.
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Time from start of treatment to time of progression or death, assessed at 2 months
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Altre misure di risultato
Misura del risultato |
Lasso di tempo |
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Time to Progression (TTP)
Lasso di tempo: Time from start of treatment to time of progression or death, assessed radiographically every 6 weeks
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Time from start of treatment to time of progression or death, assessed radiographically every 6 weeks
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Epidermal Growth Factor Receptor (EGFR) Mutational Status
Lasso di tempo: Baseline
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Baseline
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Epidermal Growth Factor Receptor (EGFR) Copy Number
Lasso di tempo: Baseline
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Baseline
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Phospho-Src (pSrc) Expression
Lasso di tempo: Baseline
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Baseline
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Faye Johnson, M.D. Anderson Cancer Center
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
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
- Inibitori enzimatici
- Agenti antineoplastici
- Inibitori della chinasi proteica
- Dasatinib
Altri numeri di identificazione dello studio
- NCI-2009-00225 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
- P30CA016672 (Sovvenzione/contratto NIH degli Stati Uniti)
- N01CM62202 (Sovvenzione/contratto NIH degli Stati Uniti)
- 7798 (Altro identificatore: CTEP)
- CDR0000538668
- 2006-0593 (Altro identificatore: M D Anderson Cancer Center)
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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