Trial Outcomes & Findings for Preoperative Chemotherapy and Bevacizumab in Patients With Stage IB (>4 cm), II, or Select Stage III NSCLC (NCT NCT00960297)
NCT ID: NCT00960297
Last Updated: 2021-12-06
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
36 months
Results posted on
2021-12-06
Participant Flow
Participant milestones
| Measure |
Carboplatin/Paclitaxel/Bevacizumab
Preoperative chemotherapy and bevacizumab
Bevacizumab : Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)
Paclitaxel : Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64
Carboplatin : Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Carboplatin/Paclitaxel/Bevacizumab
Preoperative chemotherapy and bevacizumab
Bevacizumab : Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)
Paclitaxel : Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64
Carboplatin : Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Venous port infection
|
1
|
|
Overall Study
Disease progression
|
1
|
Baseline Characteristics
Preoperative Chemotherapy and Bevacizumab in Patients With Stage IB (>4 cm), II, or Select Stage III NSCLC
Baseline characteristics by cohort
| Measure |
Carboplatin/Paclitaxel/Bevacizumab
n=4 Participants
Preoperative chemotherapy and bevacizumab
Bevacizumab : Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)
Paclitaxel : Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64
Carboplatin : Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: Study ended early due to slow accrual.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 monthsPopulation: Results were not analyzed as the study ended early due to slow accrual and incomplete data collection
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 monthsPopulation: Results were not analyzed as the study ended early due to slow accrual and incomplete data collection.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 45 monthsAn adverse event (AE) is the development of an undesirable medical condition, or the deterioration of a preexisting medical condition (other than the condition that is being treated by the trial) following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. The number of participants experiencing such adverse events are reported here.
Outcome measures
| Measure |
Carboplatin/Paclitaxel/Bevacizumab
n=4 Participants
Preoperative chemotherapy and bevacizumab
Bevacizumab : Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)
Paclitaxel : Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64
Carboplatin : Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64
|
|---|---|
|
Number of Participants Experiencing Adverse Events as a Measure of Toxicity
|
4 Participants
|
SECONDARY outcome
Timeframe: 60 monthsPopulation: Results were not analyzed as the study ended early due to slow accrual and incomplete data collection.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 monthsPopulation: Results were not analyzed as the study ended early due to slow accrual and incomplete data collection.
Outcome measures
Outcome data not reported
Adverse Events
Carboplatin/Paclitaxel/Bevacizumab
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Carboplatin/Paclitaxel/Bevacizumab
n=4 participants at risk
Preoperative chemotherapy and bevacizumab
Bevacizumab : Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)
Paclitaxel : Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64
Carboplatin : Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64
|
|---|---|
|
Gastrointestinal disorders
Colitis, nonspecific
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
25.0%
1/4 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
25.0%
1/4 • Number of events 1
|
Other adverse events
| Measure |
Carboplatin/Paclitaxel/Bevacizumab
n=4 participants at risk
Preoperative chemotherapy and bevacizumab
Bevacizumab : Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)
Paclitaxel : Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64
Carboplatin : Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension - mild
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
2/4 • Number of events 2
|
|
Metabolism and nutrition disorders
alkaline phosporus (L)
|
25.0%
1/4 • Number of events 1
|
|
Nervous system disorders
Altered mental status
|
25.0%
1/4 • Number of events 1
|
|
Blood and lymphatic system disorders
ANC
|
25.0%
1/4 • Number of events 3
|
|
Endocrine disorders
Anorexia
|
25.0%
1/4 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
2/4 • Number of events 3
|
|
Cardiac disorders
Atrial Fibrillation
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Chapped lips
|
25.0%
1/4 • Number of events 1
|
|
Metabolism and nutrition disorders
Chloride, low
|
50.0%
2/4 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
CO2
|
75.0%
3/4 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Coarse crackles, right lung base
|
25.0%
1/4 • Number of events 1
|
|
General disorders
cold sensitivity
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Colitis, nonspecific
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • Number of events 2
|
|
Metabolism and nutrition disorders
Creatinine
|
50.0%
2/4 • Number of events 3
|
|
Gastrointestinal disorders
Dark Stools
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dehisce, port site
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
50.0%
2/4 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Diminished breath sounds
|
50.0%
2/4 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Edema
|
50.0%
2/4 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Failute to thrive
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 2
|
|
Infections and infestations
Febrile neutropenia
|
25.0%
1/4 • Number of events 1
|
|
Infections and infestations
Fever
|
50.0%
2/4 • Number of events 3
|
|
Gastrointestinal disorders
Gaseous
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Body Aches, generalized
|
25.0%
1/4 • Number of events 1
|
|
Blood and lymphatic system disorders
HCT, low
|
25.0%
1/4 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Head Cold
|
25.0%
1/4 • Number of events 1
|
|
General disorders
headache
|
25.0%
1/4 • Number of events 1
|
|
Blood and lymphatic system disorders
Hematologic, ANC
|
50.0%
2/4 • Number of events 3
|
|
Blood and lymphatic system disorders
Hematologic, Hemoglobin
|
100.0%
4/4 • Number of events 9
|
|
Blood and lymphatic system disorders
Hematologic, platelets
|
50.0%
2/4 • Number of events 5
|
|
Blood and lymphatic system disorders
Hematologic, WBC
|
75.0%
3/4 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
25.0%
1/4 • Number of events 1
|
|
Metabolism and nutrition disorders
hyperglycemia
|
50.0%
2/4 • Number of events 4
|
|
Metabolism and nutrition disorders
hyperkalemia
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
hyperpigmentation
|
25.0%
1/4 • Number of events 1
|
|
Vascular disorders
hypertension
|
25.0%
1/4 • Number of events 1
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
50.0%
2/4 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
50.0%
2/4 • Number of events 3
|
|
Metabolism and nutrition disorders
hypokalemia
|
25.0%
1/4 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
2/4 • Number of events 2
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • Number of events 1
|
|
Infections and infestations
infection
|
25.0%
1/4 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
50.0%
2/4 • Number of events 2
|
|
General disorders
Malaise
|
25.0%
1/4 • Number of events 1
|
|
Psychiatric disorders
Mental Status Change
|
25.0%
1/4 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Mucositis
|
75.0%
3/4 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Number of events 3
|
|
Nervous system disorders
Neuropathy
|
50.0%
2/4 • Number of events 2
|
|
Vascular disorders
Orthostasis
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Number of events 1
|
|
Blood and lymphatic system disorders
Platelets
|
25.0%
1/4 • Number of events 8
|
|
Renal and urinary disorders
Proteinuria
|
50.0%
2/4 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
25.0%
1/4 • Number of events 1
|
|
Renal and urinary disorders
Renal insufficiency
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Rigors
|
25.0%
1/4 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Soreness, port site
|
25.0%
1/4 • Number of events 1
|
|
General disorders
Purulent Drainage
|
25.0%
1/4 • Number of events 1
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
25.0%
1/4 • Number of events 1
|
|
Investigations
Bilirubin
|
50.0%
2/4 • Number of events 2
|
|
Renal and urinary disorders
Total Protein
|
25.0%
1/4 • Number of events 4
|
|
Renal and urinary disorders
Urine Protein Creatinine Ratio
|
25.0%
1/4 • Number of events 1
|
|
Renal and urinary disorders
Urine discoloration
|
25.0%
1/4 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
100.0%
4/4 • Number of events 4
|
|
Investigations
Weightloss
|
25.0%
1/4 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
- Publication restrictions are in place
Restriction type: OTHER