Trial Outcomes & Findings for Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients With Resected Stage I-III Non-small Cell Lung Cancer (NCT NCT00675597)
NCT ID: NCT00675597
Last Updated: 2015-11-20
Results Overview
Cycle delivery is a surrogate for drug delivery. Both cycle delivery and drug delivery will be measured in this study. However, cycle delivery (up to 4 cycles) is the common way drug delivery is measured in the literature, and therefore cycle delivery has been chosen as the primary endpoint for this study.Two doses of both docetaxel plus vinorelbine, delivered over 4 weeks, constitutes one cycle. If either drug is discontinued, the subject will remain on study, however that patient will not get credit for completing subsequent cycles of therapy. If the dose of either drug is reduced, the subject will remain on study and get credit for subsequent cycles.
COMPLETED
NA
25 participants
2 years
2015-11-20
Participant Flow
Participant milestones
| Measure |
Docetaxel (Taxotere®) Plus Vinorelbine
Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Docetaxel (Taxotere®) Plus Vinorelbine
Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients With Resected Stage I-III Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Docetaxel (Taxotere®) Plus Vinorelbine
n=26 Participants
Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer
|
|---|---|
|
Age, Continuous
|
64.6 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 2 yearsCycle delivery is a surrogate for drug delivery. Both cycle delivery and drug delivery will be measured in this study. However, cycle delivery (up to 4 cycles) is the common way drug delivery is measured in the literature, and therefore cycle delivery has been chosen as the primary endpoint for this study.Two doses of both docetaxel plus vinorelbine, delivered over 4 weeks, constitutes one cycle. If either drug is discontinued, the subject will remain on study, however that patient will not get credit for completing subsequent cycles of therapy. If the dose of either drug is reduced, the subject will remain on study and get credit for subsequent cycles.
Outcome measures
| Measure |
Docetaxel (Taxotere®) Plus Vinorelbine
n=23 Participants
Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer
|
|---|---|
|
To Measure the Number of Cycles
Completed 4 cycles
|
20 participants
|
|
To Measure the Number of Cycles
Unable to complete 4 cycles
|
3 participants
|
Adverse Events
Docetaxel (Taxotere®) Plus Vinorelbine
Serious adverse events
| Measure |
Docetaxel (Taxotere®) Plus Vinorelbine
n=23 participants at risk
Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer
|
|---|---|
|
General disorders
Nausea
|
4.3%
1/23 • Number of events 1
|
|
Cardiac disorders
Atrial tachycardia/Paroxysmal Atrial Tachycardia
|
4.3%
1/23 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin, other
|
4.3%
1/23 • Number of events 1
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
4.3%
1/23 • Number of events 1
|
|
General disorders
Febrile neutropenia
|
21.7%
5/23 • Number of events 6
|
|
Blood and lymphatic system disorders
Hemoglobin
|
4.3%
1/23 • Number of events 1
|
|
Blood and lymphatic system disorders
Inf norm ANC/gr1/2 neut-Catheter-related
|
4.3%
1/23 • Number of events 1
|
|
Infections and infestations
Inf unknown ANC-Ungual(nails)
|
4.3%
1/23 • Number of events 1
|
|
Infections and infestations
Infection, other
|
4.3%
1/23 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
4.3%
1/23 • Number of events 1
|
|
General disorders
Mucositis (func/sympt)- Oral cavity
|
4.3%
1/23 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
13.0%
3/23 • Number of events 3
|
|
General disorders
Pain - Abdomen NOS
|
4.3%
1/23 • Number of events 1
|
|
Nervous system disorders
Seizure
|
4.3%
1/23 • Number of events 1
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
4.3%
1/23 • Number of events 1
|
Other adverse events
| Measure |
Docetaxel (Taxotere®) Plus Vinorelbine
n=23 participants at risk
Docetaxel (Taxotere®) plus Vinorelbine as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer
|
|---|---|
|
General disorders
Fatigue
|
60.9%
14/23 • Number of events 45
|
|
Nervous system disorders
Neuropathy
|
26.1%
6/23 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhea
|
17.4%
4/23 • Number of events 4
|
|
Blood and lymphatic system disorders
ALT, SGPT
|
8.7%
2/23 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
21.7%
5/23 • Number of events 8
|
|
General disorders
Cough
|
8.7%
2/23 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
43.5%
10/23 • Number of events 15
|
|
General disorders
Fever (in the absence of neutropenia)
|
8.7%
2/23 • Number of events 3
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
69.6%
16/23 • Number of events 16
|
|
General disorders
Hair loss/alopecia (scalp or body)
|
39.1%
9/23 • Number of events 9
|
|
Blood and lymphatic system disorders
Hemoglobin
|
60.9%
14/23 • Number of events 14
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
56.5%
13/23 • Number of events 13
|
|
Blood and lymphatic system disorders
Lymphopenia
|
21.7%
5/23 • Number of events 5
|
|
General disorders
Mucositis (Clin exam)- Oral cavity
|
34.8%
8/23 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
21.7%
5/23 • Number of events 5
|
|
General disorders
Nausea
|
13.0%
3/23 • Number of events 4
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
60.9%
14/23 • Number of events 14
|
|
General disorders
Pain - Other
|
17.4%
4/23 • Number of events 5
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
8.7%
2/23 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
8.7%
2/23 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme
|
8.7%
2/23 • Number of events 3
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
21.7%
5/23 • Number of events 8
|
Additional Information
Dr. Mark G. Kris
Memorial Sloan Kettering Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place