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Multimodality Treatment for Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) - BEACON Study: Bevacizumab and Chemotherapy for Operable NSCLC

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00130780
First received: August 12, 2005
Last updated: December 18, 2015
Last verified: December 2015
Results First Received: December 18, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma, Non-Small-Cell Lung
Interventions: Drug: Pre-surgical Treatment with Bevacizumab plus Chemotherapy
Drug: Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy

Pre-surgical Treatment with Bevacizumab plus Chemotherapy

Pre-surgical Treatment with Bevacizumab + Chemotherapy: On Cycle 1 Day 1,patient will receive bevacizumab 15 mg/kg. On Cycle 1 Day 15, patients receive docetaxel (75 mg/m2), cisplatin (75 mg/m2). Cycle 2 begins 21 days after administration of docetaxel and cisplatin in Cycle 1. In Cycles 2 thru 3, patients will receive 2 preoperative 21-day cycles of docetaxel (75 mg/m2), cisplatin (75 mg/m2), and bevacizumab (15 mg/kg), all given on Day 1 of each cycle. The sequence of administration will be docetaxel, followed by cisplatin, followed by bevacizumab according to MSKCC Chemotherapy Guidelines. In Cycle 4 Day 1, patients will receive docetaxel (75 mg/m2) and cisplatin (75 mg/m2). Bevacizumab will not be given with Cycle 4. During Cycle 4, the only scheduled clinic visit will be on Day 1. Surgery will occur at least 42 days after the last treatment with bevacizumab. Every attempt will be made to administer the treatment on sc

B: Pre-Surgical Docetaxel, Cisplatin, and Adjuvant Bevacizumab

Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab

Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab: Patients will receive preoperative 21-day cycles of cisplatin (75 mg/m2) and docetaxel (75 mg/m2) both given on Day 1 of each cycle.Patients will undergo repeat CT imaging after 2 cycles of therapy and patients with at least 10% reduction in bidimensional tumor volume will receive 2 additional neoadjuvant cycles of therapy (total 4 cycles of therapy).Surgery will occur at least 4 weeks after the last treatment with docetaxel and cisplatin.Adjuvant bevacizumab (15 mg/kg q21 days for 1 year, total 18 cycles) will be administered to all patients who undergo resection. Adjuvant bevacizumab will begin between days 42 and 56 after surgery.Patients may be referred for post-operative radiation therapy at the discretion of the treating physician. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally


Participant Flow:   Overall Study
    A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy     B: Pre-Surgical Docetaxel, Cisplatin, and Adjuvant Bevacizumab  
STARTED     51     20  
COMPLETED     51     20  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy

Pre-surgical Treatment with Bevacizumab plus Chemotherapy

Pre-surgical Treatment with Bevacizumab + Chemotherapy: On Cycle 1 Day 1,patient will receive bevacizumab 15 mg/kg. On Cycle 1 Day 15, patients receive docetaxel (75 mg/m2), cisplatin (75 mg/m2). Cycle 2 begins 21 days after administration of docetaxel and cisplatin in Cycle 1. In Cycles 2 thru 3, patients will receive 2 preoperative 21-day cycles of docetaxel (75 mg/m2), cisplatin (75 mg/m2), and bevacizumab (15 mg/kg), all given on Day 1 of each cycle. The sequence of administration will be docetaxel, followed by cisplatin, followed by bevacizumab according to MSKCC Chemotherapy Guidelines. In Cycle 4 Day 1, patients will receive docetaxel (75 mg/m2) and cisplatin (75 mg/m2). Bevacizumab will not be given with Cycle 4. During Cycle 4, the only scheduled clinic visit will be on Day 1. Surgery will occur at least 42 days after the last treatment with bevacizumab. Every attempt will be made to administer the treatment on sc

B: Pre-Surgical Docetaxel, Cisplatin, and Adjuvant Bevacizumab

Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab

Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab: Patients will receive preoperative 21-day cycles of cisplatin (75 mg/m2) and docetaxel (75 mg/m2) both given on Day 1 of each cycle.Patients will undergo repeat CT imaging after 2 cycles of therapy and patients with at least 10% reduction in bidimensional tumor volume will receive 2 additional neoadjuvant cycles of therapy (total 4 cycles of therapy).Surgery will occur at least 4 weeks after the last treatment with docetaxel and cisplatin.Adjuvant bevacizumab (15 mg/kg q21 days for 1 year, total 18 cycles) will be administered to all patients who undergo resection. Adjuvant bevacizumab will begin between days 42 and 56 after surgery.Patients may be referred for post-operative radiation therapy at the discretion of the treating physician. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally

Total Total of all reporting groups

Baseline Measures
    A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy     B: Pre-Surgical Docetaxel, Cisplatin, and Adjuvant Bevacizumab     Total  
Number of Participants  
[units: participants]
  51     20     71  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     36     16     52  
>=65 years     15     4     19  
Gender  
[units: participants]
     
Female     31     7     38  
Male     20     13     33  
Region of Enrollment  
[units: participants]
     
United States     51     20     71  



  Outcome Measures

1.  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.   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Mark Kris, Attending
Organization: Memorial Sloan Kettering Cancer Center
phone: +1646-888-4205
e-mail: krism@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00130780     History of Changes
Other Study ID Numbers: 05-052
Study First Received: August 12, 2005
Results First Received: December 18, 2015
Last Updated: December 18, 2015
Health Authority: United States: Institutional Review Board