- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00334763
Radiation Therapy, Chemotherapy, and Bevacizumab in Treating Patients With Recurrent, Unresectable or Stage III or Stage IV Non-Small Cell Lung Cancer
Phase II Study of Radiation Followed by Paclitaxel, Carboplatin, and Bevacizumab (PCA) in Patients With Stage IIIB and IV Squamous Non-Small Cell Lung Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving radiation therapy together with chemotherapy and monoclonal antibody therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving radiation therapy together with chemotherapy and bevacizumab works in treating patients with recurrent, unresectable or stage III or stage IV non-small cell lung cancer.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
OBJECTIVES:
Primary
- Evaluate reduction in toxicity, in terms of pulmonary hemorrhage, in patients with recurrent, unresectable or stage IIIB or IV squamous non-small cell lung cancer treated with radiotherapy followed by paclitaxel, carboplatin, and bevacizumab.
Secondary
- Determine the overall and progression-free survival of patients treated with this regimen.
OUTLINE: Patients undergo radiotherapy to the primary tumor, clinically involved lymph nodes, and any other disease-causing symptoms or bronchial compression once daily, 5 days a week, for 2 weeks in weeks 1 and 2. Beginning in week 4, patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment with paclitaxel, carboplatin, and bevacizumab repeats every 3 weeks for 4 courses in the absence of unacceptable toxicity. Patients achieving complete response, partial response, or stable disease after 4 courses receive bevacizumab alone as above in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
-
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Alabama
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Birmingham, Alabama, Stati Uniti, 35294
- Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
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Illinois
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Chicago, Illinois, Stati Uniti, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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Evanston, Illinois, Stati Uniti, 60201-1781
- Evanston Northwestern Healthcare - Evanston Hospital
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Texas
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Dallas, Texas, Stati Uniti, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Predominantly squamous cell histology
- Cytologic or histologic elements can be established on metastatic tumor aspirates or biopsy
Advanced disease, meeting 1 of the following staging criteria:
- Stage IIIB disease with malignant pleural effusion
- Stage IV disease
- Recurrent, unresectable disease
- Measurable or nonmeasurable disease
- No extrathoracic only disease
- No known CNS metastases by head CT scan with contrast or MRI
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Platelet count > 100,000/mm^3
- Absolute neutrophil count > 1,500/mm^3
- Bilirubin < 1.5 mg/dL
- Transaminases < 5 times upper limit of normal (ULN)
- Creatinine clearance ≥ 45 mL/min
- Urine protein:creatinine ratio ≤ 1.0 by spot urinalysis
- INR < 1.5 ULN
- PTT normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients use effective contraception
- No serious nonhealing wound, ulcer, or bone fracture
- No ongoing or active infection
- No ongoing fever
- No myocardial infarction within the past 6 months
- No stroke within the past 6 months
- No history of hypertension unless well-controlled (i.e., blood pressure < 150/100 mmHg on a stable regimen of antihypertensive therapy)
- No New York Heart Association grade III or IV congestive heart failure
- No serious cardiac arrhythmia requiring medication
- No unstable angina pectoris
- No peripheral vascular disease ≥ grade 2
- No other clinically significant cardiovascular disease
- No abdominal fistula
- No gastrointestinal perforation
- No intra-abdominal abscess within the past 6 months
- No psychiatric illness or social situation that would preclude study compliance
- No other malignancy curatively treated within the past 5 years
- No history of thrombotic or hemorrhagic disorders
- No gross hemoptysis (i.e., red blood ≥ ½ teaspoon) within the past 3 months
- No bleeding requiring intervention or ≥ grade 2
PRIOR CONCURRENT THERAPY:
- Recovered from prior therapy
- No prior systemic chemotherapy for metastatic NSCLC
- More than 6 months since prior adjuvant chemotherapy for early stage (i.e., stage IB-IIIA) NSCLC
- More than 3 weeks since prior immunotherapy, hormonal therapy, or radiotherapy
- More than 28 days since prior and no concurrent major surgery
- More than 7 days since prior minor surgery, fine-needle aspiration, or core biopsy
- More than 4 weeks since prior and no concurrent participation in another experimental drug study
No concurrent therapeutic anticoagulation
- Concurrent prophylactic anticoagulation of venous access device allowed
- No concurrent chronic treatment with aspirin (> 325 mg/day) or nonsteroidal anti-inflammatory drugs known to inhibit platelet function
- No concurrent dipyridamole, ticlopidine, clopidogrel, or cilostazol
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Mascheramento: Nessuno (etichetta aperta)
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
|---|
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Reduction in toxicity measured by pulmonary hemorrhage rate
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Misure di risultato secondarie
Misura del risultato |
|---|
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Tossicità
|
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Tasso di risposta
|
|
Overall survival by Kaplan-Meier
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Jyoti D. Patel, Robert H. Lurie 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 (Stima)
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
- Meccanismi molecolari dell'azione farmacologica
- Agenti antineoplastici
- Modulatori della tubulina
- Agenti antimitotici
- Modulatori della mitosi
- Agenti antineoplastici, fitogenici
- Agenti antineoplastici, immunologici
- Inibitori dell'angiogenesi
- Agenti di modulazione dell'angiogenesi
- Sostanze per la crescita
- Inibitori della crescita
- Carboplatino
- Paclitaxel
- Bevacizumab
Altri numeri di identificazione dello studio
- NU 05L1
- NU-05L1
- NU-1362-038
- GENENTECH-AVF3646s
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 .