Trial Outcomes & Findings for Multimodality Treatment for Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) - BEACON Study: Bevacizumab and Chemotherapy for Operable NSCLC (NCT NCT00130780)
NCT ID: NCT00130780
Last Updated: 2016-01-25
Results Overview
These criteria have been modified for the purpose of this study (i.e.: there will be no confirmation of response at 4 weeks per usual response criteria as this is not applicable to the preoperative treatment plan): Complete Response (CR): Disappearance of all clinical evidence of tumor. Partial Response (PR): A 50% or greater decrease in the sum of the products of measured lesions. No simultaneous increase in the size of any lesion or the appearance of new lesions may occur. Non-measurable lesions must remain stable or regress for this category. Minor Response (MR): A \> 25% and \< 50% decrease in the sum of the products of measured lesions. No simultaneous increase in the size of any lesion or the appearance of new lesions may occur. Non-measurable lesions must remain stable or regress for this category. Stable Disease (SD): A less than 25% decrease. This includes a decrease of less than 25% in the sum of the products of the meas
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
2 years
Results posted on
2016-01-25
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
20
|
|
Overall Study
COMPLETED
|
51
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multimodality Treatment for Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) - BEACON Study: Bevacizumab and Chemotherapy for Operable NSCLC
Baseline characteristics by cohort
| Measure |
A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy
n=51 Participants
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
n=20 Participants
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
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
20 participants
n=7 Participants
|
71 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsThese criteria have been modified for the purpose of this study (i.e.: there will be no confirmation of response at 4 weeks per usual response criteria as this is not applicable to the preoperative treatment plan): Complete Response (CR): Disappearance of all clinical evidence of tumor. Partial Response (PR): A 50% or greater decrease in the sum of the products of measured lesions. No simultaneous increase in the size of any lesion or the appearance of new lesions may occur. Non-measurable lesions must remain stable or regress for this category. Minor Response (MR): A \> 25% and \< 50% decrease in the sum of the products of measured lesions. No simultaneous increase in the size of any lesion or the appearance of new lesions may occur. Non-measurable lesions must remain stable or regress for this category. Stable Disease (SD): A less than 25% decrease. This includes a decrease of less than 25% in the sum of the products of the meas
Outcome measures
| Measure |
A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy
n=51 Participants
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
n=20 Participants
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
|
|---|---|---|
|
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 participants
|
20 participants
|
Adverse Events
A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy
Serious events: 28 serious events
Other events: 49 other events
Deaths: 0 deaths
B: Pre-Surgical Docetaxel, Cisplatin, and Adjuvant Bevacizumab
Serious events: 6 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy
n=51 participants at risk
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
n=20 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
Dehydration
|
7.8%
4/51 • Number of events 5
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
3.9%
2/51 • Number of events 2
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
9.8%
5/51 • Number of events 6
|
0.00%
0/20
|
|
Gastrointestinal disorders
Enteritis (inflamm of small bowel)
|
3.9%
2/51 • Number of events 2
|
0.00%
0/20
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
3.9%
2/51 • Number of events 2
|
0.00%
0/20
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.8%
4/51 • Number of events 4
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis (Clin exam)- Oral cavity
|
3.9%
2/51 • Number of events 2
|
0.00%
0/20
|
|
Gastrointestinal disorders
Nausea
|
3.9%
2/51 • Number of events 2
|
0.00%
0/20
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
7.8%
4/51 • Number of events 4
|
10.0%
2/20 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest/thorax NOS
|
3.9%
2/51 • Number of events 2
|
0.00%
0/20
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/51
|
10.0%
2/20 • Number of events 3
|
Other adverse events
| Measure |
A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy
n=51 participants at risk
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
n=20 participants at risk
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
|
|---|---|---|
|
Metabolism and nutrition disorders
ALT, SGPT
|
2.0%
1/51 • Number of events 6
|
15.0%
3/20 • Number of events 10
|
|
Metabolism and nutrition disorders
Albumin, low (hypoalbuminemia)
|
35.3%
18/51 • Number of events 54
|
15.0%
3/20 • Number of events 8
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
5.9%
3/51 • Number of events 17
|
5.0%
1/20 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
17.6%
9/51 • Number of events 13
|
5.0%
1/20 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.8%
5/51 • Number of events 11
|
10.0%
2/20 • Number of events 4
|
|
Investigations
Creatinine
|
7.8%
4/51 • Number of events 10
|
10.0%
2/20 • Number of events 2
|
|
Gastrointestinal disorders
Dehydration
|
3.9%
2/51 • Number of events 4
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
19.6%
10/51 • Number of events 14
|
15.0%
3/20 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
9.8%
5/51 • Number of events 8
|
5.0%
1/20 • Number of events 2
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
66.7%
34/51 • Number of events 106
|
45.0%
9/20 • Number of events 20
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
78.4%
40/51 • Number of events 90
|
75.0%
15/20 • Number of events 41
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
25.5%
13/51 • Number of events 18
|
15.0%
3/20 • Number of events 6
|
|
Blood and lymphatic system disorders
Hemoglobin
|
68.6%
35/51 • Number of events 79
|
55.0%
11/20 • Number of events 22
|
|
Respiratory, thoracic and mediastinal disorders
Hypertension
|
7.8%
4/51 • Number of events 6
|
0.00%
0/20
|
|
Blood and lymphatic system disorders
Leukocytosis
|
29.4%
15/51 • Number of events 23
|
20.0%
4/20 • Number of events 6
|
|
Investigations
Lymphopenia
|
29.4%
15/51 • Number of events 21
|
35.0%
7/20 • Number of events 14
|
|
Metabolism and nutrition disorders
Magnesium, low (hypomagnesemia)
|
15.7%
8/51 • Number of events 12
|
10.0%
2/20 • Number of events 3
|
|
Gastrointestinal disorders
Mucositis (Clin exam)- Oral cavity
|
23.5%
12/51 • Number of events 29
|
20.0%
4/20 • Number of events 5
|
|
Gastrointestinal disorders
Nausea
|
25.5%
13/51 • Number of events 32
|
10.0%
2/20 • Number of events 6
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
39.2%
20/51 • Number of events 26
|
20.0%
4/20 • Number of events 4
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
25.5%
13/51 • Number of events 14
|
30.0%
6/20 • Number of events 6
|
|
Investigations
Platelets
|
9.8%
5/51 • Number of events 8
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Potassium, high (hyperkalemia)
|
13.7%
7/51 • Number of events 10
|
0.00%
0/20
|
|
Investigations
Potassium, low (hypokalemia)
|
5.9%
3/51 • Number of events 3
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
17.6%
9/51 • Number of events 12
|
10.0%
2/20 • Number of events 2
|
|
Ear and labyrinth disorders
Tinnitus
|
23.5%
12/51 • Number of events 19
|
20.0%
4/20 • Number of events 9
|
Additional Information
Dr. Mark Kris, Attending
Memorial Sloan Kettering Cancer Center
Phone: +1646-888-4205
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place