- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 35294
- Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
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Illinois
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Chicago, Illinois, États-Unis, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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Evanston, Illinois, États-Unis, 60201-1781
- Evanston Northwestern Healthcare - Evanston Hospital
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Tennessee
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Nashville, Tennessee, États-Unis, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Texas
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Dallas, Texas, États-Unis, 75390
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Masquage: Aucun (étiquette ouverte)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
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Reduction in toxicity measured by pulmonary hemorrhage rate
|
Mesures de résultats secondaires
Mesure des résultats |
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Toxicité
|
Taux de réponse
|
Overall survival by Kaplan-Meier
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Jyoti D. Patel, Robert H. Lurie Cancer Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies des voies respiratoires
- Tumeurs
- Maladies pulmonaires
- Tumeurs par site
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Carcinome bronchique
- Tumeurs bronchiques
- Tumeurs pulmonaires
- Carcinome pulmonaire non à petites cellules
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents antinéoplasiques
- Modulateurs de tubuline
- Agents antimitotiques
- Modulateurs de mitose
- Agents antinéoplasiques phytogéniques
- Agents antinéoplasiques immunologiques
- Inhibiteurs de l'angiogenèse
- Agents modulateurs de l'angiogenèse
- Substances de croissance
- Inhibiteurs de croissance
- Carboplatine
- Paclitaxel
- Bévacizumab
Autres numéros d'identification d'étude
- NU 05L1
- NU-05L1
- NU-1362-038
- GENENTECH-AVF3646s
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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-
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