Trial Outcomes & Findings for Carboplatin and Gemcitabine With Bevacizumab Every 2 Weeks for Stage IIIb/IV Non-small Cell Lung Cancer (NCT NCT00400803)

Last Updated: 2017-12-28

Results Overview

Time to progression (progression free survival)is defined as the time from the start of treatment until first documented sign of disease progression or death due to any cause. For subjects who do not progress, time to progression will be censored at the time of last tumor assessment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

38 participants

Primary outcome timeframe

From Enrollment Through 2 Years

Results posted on

2017-12-28

Participant Flow

38 Patients with stage IIIb/IV non-small cell lung cancer were recruited at two institutions in Minnesota: Masonic Cancer Center at University of Minnesota and North Memorial Research Center (Hubert H. Humphrey Cancer Center).

Outcome data analysis is only available for 35 of 38 patients in database. Three patients are excluded: 1 never enrolled, 1 has no record of treatment and fup, 1 has no treatment fup.

Participant milestones

Participant milestones
Measure	Intent To Treat - Lung Cancer Patients Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m\^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
Overall Study STARTED	35
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Carboplatin and Gemcitabine With Bevacizumab Every 2 Weeks for Stage IIIb/IV Non-small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intent To Treat - Lung Cancer Patients n=35 Participants Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m\^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants
Age, Continuous	65 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants

PRIMARY outcome

Timeframe: From Enrollment Through 2 Years

Outcome measures

Outcome measures
Measure	Intent To Treat - Lung Cancer Patients n=35 Participants Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m\^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.	Partial Response At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met.	Stable Disease Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. To be assigned a status of stable disease, measurements must have met the stable disease criteria at least once after study entry at a minimum interval.	Progressive Disease At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).
Time to Progression	3.1 Months Standard Error 0.4 • Interval 79.0 to 100.0	—	—	—

SECONDARY outcome

Timeframe: After Cycle 4, Cycle 6 and Cycle 7 of Therapy

Population: For subjects who show a response, duration of response is defined to be the time from first documented evidence of response until the first documented sign of disease progression or death due to any cause. For subjects who do not progress or die, duration of response will be censored at the time of last tumor assessment. 5 patients = missing data.

Number of patients and their best response recorded from the state of treatment until disease progression. Response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response-disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that did not meet above criteria.

Outcome measures

Outcome measures
Measure	Intent To Treat - Lung Cancer Patients n=35 Participants Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m\^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.	Partial Response n=19 Participants At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met.	Stable Disease n=10 Participants Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. To be assigned a status of stable disease, measurements must have met the stable disease criteria at least once after study entry at a minimum interval.	Progressive Disease n=6 Participants At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).
Best Overall Response by Cycle Cycle 7	4 Participants	2 Participants	2 Participants	0 Participants
Best Overall Response by Cycle Cycle 1	1 Participants	0 Participants	0 Participants	1 Participants
Best Overall Response by Cycle Cycle 2	1 Participants	0 Participants	0 Participants	1 Participants
Best Overall Response by Cycle Cycle 3	3 Participants	0 Participants	2 Participants	1 Participants
Best Overall Response by Cycle Cycle 4	24 Participants	15 Participants	6 Participants	3 Participants
Best Overall Response by Cycle Cycle 5	0 Participants	0 Participants	0 Participants	0 Participants
Best Overall Response by Cycle Cycle 6	2 Participants	2 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Enrollment through Date of First Documented Disease Progression or Date of Death From Any Cause, Whichever Came First, Up to 100 Months

For subjects who show a response, duration of response is defined to be the time from first documented evidence of response(30% decrease or complete disappearance of tumor) until the first documented sign of disease progression or death due to any cause. For subjects who do not progress or die, duration of response will be censored at the time of last tumor assessment.

Outcome measures

Outcome measures
Measure	Intent To Treat - Lung Cancer Patients n=35 Participants Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m\^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.	Partial Response At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met.	Stable Disease Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. To be assigned a status of stable disease, measurements must have met the stable disease criteria at least once after study entry at a minimum interval.	Progressive Disease At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).
Duration of Response	105 Days Interval 4.0 to 451.0	—	—	—

SECONDARY outcome

Timeframe: Baseline to Death

Overall survival is defined as the time from the start of treatment until death due to whatever cause. For subjects alive at study completion, time to death will be censored at the time of last contact.

Outcome measures

Outcome measures
Measure	Intent To Treat - Lung Cancer Patients n=35 Participants Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m\^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.	Partial Response At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met.	Stable Disease Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. To be assigned a status of stable disease, measurements must have met the stable disease criteria at least once after study entry at a minimum interval.	Progressive Disease At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).
Overall Survival Time	14.3 Months Standard Error 1.3	—	—	—

SECONDARY outcome

Timeframe: From Enrollment to First Tumor Response

Time to best response is defined as the time from the start of treatment until first documented evidence of tumor response (30% decrease or complete disappearance of tumor). For subjects who do not show a tumor response, the time will be censored at the time of last contact.

Outcome measures

Outcome measures
Measure	Intent To Treat - Lung Cancer Patients n=35 Participants Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m\^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.	Partial Response At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met.	Stable Disease Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. To be assigned a status of stable disease, measurements must have met the stable disease criteria at least once after study entry at a minimum interval.	Progressive Disease At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).
Time to Best Response	72 Days Interval 42.0 to 748.0	—	—	—

Adverse Events

Intent To Treat - Lung Cancer Patients

Serious events: 17 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intent To Treat - Lung Cancer Patients n=38 participants at risk Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m\^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
Nervous system disorders Ataxia	2.6% 1/38 • Number of events 1
General disorders Back Pain	2.6% 1/38 • Number of events 1
Endocrine disorders Bilateral hearing loss	2.6% 1/38 • Number of events 1
Gastrointestinal disorders Constipation	2.6% 1/38 • Number of events 1
Gastrointestinal disorders Diarrhea	5.3% 2/38 • Number of events 3
Nervous system disorders Dizziness	5.3% 2/38 • Number of events 2
General disorders Fatigue	2.6% 1/38 • Number of events 1
Infections and infestations Fever	2.6% 1/38 • Number of events 1
General disorders Headache	5.3% 2/38 • Number of events 2
Reproductive system and breast disorders Hemorrhage, pulmonary	2.6% 1/38 • Number of events 2
Cardiac disorders Hypertension	5.3% 2/38 • Number of events 2
Musculoskeletal and connective tissue disorders Joint Pain	2.6% 1/38 • Number of events 1
General disorders Neck Pain	2.6% 1/38 • Number of events 1
Infections and infestations Neutropenia	2.6% 1/38 • Number of events 1
Musculoskeletal and connective tissue disorders Pain, musculoskeletal	2.6% 1/38 • Number of events 1
Metabolism and nutrition disorders Proteinuria	2.6% 1/38 • Number of events 1
Vascular disorders Pulmonary embolism	10.5% 4/38 • Number of events 4
Nervous system disorders Sensory neuropathy	2.6% 1/38 • Number of events 2
Nervous system disorders Syncope	2.6% 1/38 • Number of events 2
Skin and subcutaneous tissue disorders Thrombocytopenia (bruising)	2.6% 1/38 • Number of events 1
Gastrointestinal disorders Vomiting	2.6% 1/38 • Number of events 1

Other adverse events

Other adverse events
Measure	Intent To Treat - Lung Cancer Patients n=38 participants at risk Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m\^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
Immune system disorders Allergy/immunology	7.9% 3/38 • Number of events 3
Ear and labyrinth disorders Auditory/Ear	7.9% 3/38 • Number of events 3
Blood and lymphatic system disorders Blood/bone marrow	15.8% 6/38 • Number of events 12
Cardiac disorders Cardiac general	31.6% 12/38 • Number of events 13
General disorders Constitutional symptoms	63.2% 24/38 • Number of events 48
Skin and subcutaneous tissue disorders Dermatology/skin	21.1% 8/38 • Number of events 18
Endocrine disorders Endocrine	5.3% 2/38 • Number of events 2
Gastrointestinal disorders Gastrointestinal	71.1% 27/38 • Number of events 105
Blood and lymphatic system disorders Hemorrhage/bleeding	5.3% 2/38 • Number of events 3
Infections and infestations Infection	21.1% 8/38 • Number of events 10
Immune system disorders Lymphatics	15.8% 6/38 • Number of events 9
Metabolism and nutrition disorders Metabolic/laboratory	18.4% 7/38 • Number of events 13
Musculoskeletal and connective tissue disorders Musculoskeletal/soft tissue	13.2% 5/38 • Number of events 7
Nervous system disorders Neurology	31.6% 12/38 • Number of events 20
Eye disorders Ocular/visual	21.1% 8/38 • Number of events 9
General disorders Pain	60.5% 23/38 • Number of events 68
Respiratory, thoracic and mediastinal disorders Pulmonary/upper respiratory	57.9% 22/38 • Number of events 43
Renal and urinary disorders Renal/genitourinary	10.5% 4/38 • Number of events 4
General disorders Syndromes	5.3% 2/38 • Number of events 2

Additional Information

Arkadiusz Dudek, M.D.

Masonic Cancer Center, University of Minnesota

Phone: 612-624-0123

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place