Trial Outcomes & Findings for Carboplatin, Abraxane, and Bevacizumab in Previously Untreated Patients With Advanced Non-Small Cell Lung Cancer (NCT NCT00642759)

Last Updated: 2017-04-07

Results Overview

Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

36 participants

Primary outcome timeframe

6 Months

Results posted on

2017-04-07

Participant Flow

Participant milestones

Participant milestones
Measure	Chemotherapy carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles Bevacizumab
Overall Study STARTED	36
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Chemotherapy carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles Bevacizumab
Overall Study Protocol Violation	1

Baseline Characteristics

Carboplatin, Abraxane, and Bevacizumab in Previously Untreated Patients With Advanced Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemotherapy n=36 Participants carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles Bevacizumab
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	64 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Months

Outcome measures

Outcome measures
Measure	Chemotherapy n=36 Participants carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles Bevacizumab
6-month Progression Free Survival Rate	74 percentage of participants Interval 57.0 to 97.0

SECONDARY outcome

Timeframe: 3 years

Objective response rate to carboplatin, Abraxane and Avastin according to Response Evaluation Criteria in Solid Tumors \[Version 1.0\]

Outcome measures

Outcome measures
Measure	Chemotherapy n=36 Participants carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles Bevacizumab
Objective Response Rate to Carboplatin, Abraxane and Avastin Partial Response	13 Participants
Objective Response Rate to Carboplatin, Abraxane and Avastin Stable Disease	13 Participants
Objective Response Rate to Carboplatin, Abraxane and Avastin Progressive Disease	2 Participants
Objective Response Rate to Carboplatin, Abraxane and Avastin Not Evaluable for Response	8 Participants

SECONDARY outcome

Timeframe: 6 months

The percentage of participants surviving at least six months after baseline

Outcome measures

Outcome measures
Measure	Chemotherapy n=36 Participants carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles Bevacizumab
6 Month Survival Rate	83 percentage of participants surviving Interval 65.0 to 91.0

SECONDARY outcome

Timeframe: 3 years

The median overall survival in months

Outcome measures

Outcome measures
Measure	Chemotherapy n=36 Participants carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles Bevacizumab
Overall Survival	13.7 Months Interval 9.3 to 24.9

Adverse Events

Chemotherapy

Serious events: 7 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Chemotherapy n=36 participants at risk carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles Bevacizumab
Vascular disorders Thrombosis/thrombus/embolism	11.1% 4/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Blood and lymphatic system disorders Neutrophils	8.3% 3/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Blood and lymphatic system disorders Platelets	2.8% 1/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Metabolism and nutrition disorders ALT - SGPT	2.8% 1/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Metabolism and nutrition disorders ALT - SGOT	2.8% 1/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.

Other adverse events

Other adverse events
Measure	Chemotherapy n=36 participants at risk carboplatin: Given by infusion on day 1 of each 3 week cycle for a maximum of 6 cycles Abraxane: Given by infusion once weekly (days 1, 8 and 15) of each three week cycle for a maximum of 6 cycles Bevacizumab
General disorders Fatigue	72.2% 26/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Metabolism and nutrition disorders Proteinuria	8.3% 3/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Gastrointestinal disorders Anorexia	27.8% 10/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Gastrointestinal disorders Dysgeusia	16.7% 6/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Gastrointestinal disorders Nausea	75.0% 27/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Gastrointestinal disorders Vomiting	19.4% 7/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Gastrointestinal disorders dehydration	25.0% 9/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Gastrointestinal disorders Diarrhea	22.2% 8/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Gastrointestinal disorders Constipation	19.4% 7/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Gastrointestinal disorders Dyspepsia	5.6% 2/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
General disorders Pain	25.0% 9/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Skin and subcutaneous tissue disorders Alopecia	41.7% 15/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Nervous system disorders Neuropathy	27.8% 10/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Skin and subcutaneous tissue disorders Rash	8.3% 3/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Infections and infestations Infection	11.1% 4/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Renal and urinary disorders Renal	8.3% 3/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Vascular disorders Hypertension	19.4% 7/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Vascular disorders Thrombosis/thrombus/embolism	8.3% 3/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Gastrointestinal disorders GI bleeding	5.6% 2/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Vascular disorders Epistaxis	25.0% 9/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Blood and lymphatic system disorders White Blood Cell Count	16.7% 6/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Blood and lymphatic system disorders Absolute Neutrophil count	52.8% 19/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Blood and lymphatic system disorders Hemoglobin	55.6% 20/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Blood and lymphatic system disorders Platelets	30.6% 11/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Metabolism and nutrition disorders ALT, SGPT	13.9% 5/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Metabolism and nutrition disorders Alkaline phosphatase	8.3% 3/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.
Metabolism and nutrition disorders Hyponatremia	8.3% 3/36 • Adverse events were collected throughout duration of study Adverse events were evaluated on day 1 of cycle 1 and every three weeks prior to chemotherapy and prior to each Avastin dose. Adverse events were then assessed every three months after the completion of 6 cycles of carboplatin, Abraxane, and Avastin until tumor progression or withdrawal from study.

Additional Information

Dr. Rebecca Heist

Massachusetts General Hospital

Phone: 6177244000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place