Phase 2
N=71
Multimodality Treatment for Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) - BEACON Study: Bevacizumab and Chemotherapy for Operable NSCLC
Carcinoma, Non-Small-Cell Lung
Bottom Line
View on ClinicalTrials.gov: NCT00130780 ↗Enrolled (actual)
71
Serious AEs
47.9%
Results posted
Jan 2016
Primary outcome: Primary: The Primary Goal of This Study is to Show That the Addition of Bevacizumab to Cisplatin-based Chemotherapy in the Neoadjuvant Setting for Non-squamous Cell Carcinomas Improves Therapeutic Response/Outcome Assessment. — 51; 20 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pre-surgical Treatment with Bevacizumab plus Chemotherapy (Drug); Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Goal of This Study is to Show That the Addition of Bevacizumab to Cisplatin-based Chemotherapy in the Neoadjuvant Setting for Non-squamous Cell Carcinomas Improves Therapeutic Response/Outcome Assessment. |
51; 20 | — |
Summary
This is a phase II, single institution trial for patients with clinical Stage IB-IIIA NSCLC (T1-3N0-2M0) who have resectable lung tumors. The primary goal of this study is to show that the addition of bevacizumab to a cisplatin-based chemotherapy in the neoadjuvant setting for non-squamous cell carcinomas improves the rate of pathologic downstaging, which correlates with survival. Downstaging is defined as any decrease in the final pathologic stage compared with the clinical stage before induction therapy.
Eligibility Criteria
Inclusion Criteria
- Pathologic confirmation of NSCLC at Memorial Sloan-Kettering Cancer Center (MSKCC)
- Stages IB, IIA, IIB or IIIA (T1-3N0-2M 0) NSCLC
- Patients must be candidates for resection with curative intent.
- Measurable disease, defined as at least one lesion that can be accurately measured in at least two dimensions
- Age >= 18 years
- Karnofsky performance status >= 70%
- Normal marrow function: leukocytes >= 3,000/µl; absolute neutrophil count ≥ 1,500µl; platelets >= 100,000 µl; hemoglobin >= 9gm/dl.
- Adequate renal function, with creatinine = 60ml/min by Cockcroft-Gault equation using parameters of age, weight (kg), and baseline serum creatinine (mg/dl)
- Adequate hepatic function: total bilirubin within normal limits; AST grade 1.
- Uncontrolled hypertension
- Esophageal varices, non-healing ulcer, wound, or bone fracture
- Known HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with the study drugs.
- Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), symptomatic diverticulitis, or active uncontrolled infection.
- Women who are pregnant or breast-feeding
- Psychiatric illness or social situation that would limit compliance with study requirements
- Exclusion criteria for group A: Patients with SQUAMOUS CELL carcinoma, large central tumor in proximity to significant blood vessels, or any history of hemoptysis (will be excluded from group A (preoperative chemotherapy plus bevacizumab); these patients will be assigned to group B (preoperative chemotherapy).
Data sourced from ClinicalTrials.gov (NCT00130780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.