Phase II Trial of Bevacizumab in Combination With Cisplatin/Etoposide and Twice Daily Radiation for Patients With Limited-Stage Small Cell Lung Cancer
Collecte de données
Néoplasmes bronchiques+7
+ Carcinome bronchogénique
+ Néoplasmes pulmonaires
Étude thérapeutique
Résumé
Date de début de l'étude : 1 octobre 2006
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Primary * Determine the 1-year progression-free survival of patients with limited-stage small cell lung cancer treated with bevacizumab, cisplatin, etoposide, and radiotherapy. Secondary * Determine the toxicity of this regimen in these patients. * Determine the response rate in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive cisplatin IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 1 and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. During course 1, patients also undergo thoracic radiotherapy twice daily on days 1-5, 8-12, and 15-19. Patients achieving a complete or partial response or stable disease after the first 4 courses of chemotherapy continue to receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Within 4-6 weeks after blood counts recover from the first 4 courses of chemotherapy, patients achieving a complete or partial response also undergo prophylactic cranial irradiation (PCI) in 10 fractions over 3 weeks.\* NOTE: \*Bevacizumab should not be given for 3 weeks prior to or during PCI, but resumed 1 week after completion of PCI. After completion of study treatment, patients are followed periodically for 10 years. PROJECTED ACCRUAL: A total of 79 patients will be accrued for this study.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.79 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed small cell lung cancer (SCLC) * Limited-stage disease, defined as SCLC confined to ≥ 1 of the following: * One hemithorax * Ipsilateral supraclavicular fossa * Measurable disease * No malignant pleural effusion, contralateral hilar disease, or contralateral supraclavicular disease * Minimal pleural effusion visible on CT scan of the chest, but not evident on chest x-ray, allowed * No completely surgically resected disease * No CNS disease, including primary brain tumor or brain metastasis PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Absolute granulocyte count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ 1.5 mg/dL * Creatinine ≤ 1.5 mg/dL * Urine protein:creatinine ratio ≤ 0.5 OR 24-hour urine protein \< 1,000 mg * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment * INR ≤ 1.5 (unless on full-dose anticoagulants) * No active serious infection * No serious or nonhealing wound * No ulcer or bone fracture * No evidence of bleeding diatheses or coagulopathy * No hemoptysis * No known hypersensitivity to Chinese hamster ovary cell products and/or other recombinant human antibodies * No clinically significant cardiovascular disease, including any of the following: * Uncontrolled hypertension * New York Heart Association class II-IV congestive heart failure * Serious cardiac arrhythmia requiring medication * Unstable angina pectoris * Symptomatic peripheral vascular disease * Cerebrovascular accident within the past 6 months * Symptomatic heart disease within the past 6 months * Myocardial infarction within the past 6 months * Unstable angina within the past 6 months * No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 4 weeks * No significant traumatic injury within the past 4 weeks PRIOR CONCURRENT THERAPY: * At least 4 weeks since prior major surgery or open biopsy * At least 1 week since prior core biopsy * No prior chemotherapy or radiotherapy for small cell lung cancer * No concurrent major surgery * No concurrent palliative local radiotherapy * No concurrent intensity-modulated radiotherapy * Concurrent full-dose anticoagulants (e.g., warfarin) allowed provided all of the following criteria are met: * INR ≤ 3 * In-range INR (2-3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin * No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Objectifs secondaires