Trial Outcomes & Findings for Carboplatin, Bevacizumab and Pemetrexed in Advanced Non Small Cell Lung Cancer (NCT NCT00614822)

Last Updated: 2019-03-20

Results Overview

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year").

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year").

Results posted on

2019-03-20

Participant Flow

Between November 2007 and March 2012, 50 patients were enrolled in the phase II trial of carboplatin, pemetrexed and bevacizumab. Patients were enrolled over a 24month period.

Carboplatin, Penetrexed and Bevacizumab in Advanced Non-Squamous Non-Small Cell Lung Cancer

Participant milestones

Participant milestones
Measure	One Arm for Study Carboplatin, Pemetrexed and Bevacizumab are given day 1 every 3 weeks for 6 cycles and will be continued if patient tolerates treatments and has stable disease. The Bevacizumab will be continued every 3 weeks for 1 year if the patient tolerates treatment and has stable disease. Carboplatin, Pemetrexed and Bevacizumab: Carboplatin AUC 5 IV day 1 over 30-60 minutes Pemetrexed 500 mg/M2 IV day 1 over 10 minutes Bevacizumab 15 mg /kg IV day over 90 minutes dose 1, 60 minutes dose 2, 30 minutes subsequent doses. Repeat every 3 weeks for total of 6 cycles
Overall Study STARTED	50
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	One Arm for Study Carboplatin, Pemetrexed and Bevacizumab are given day 1 every 3 weeks for 6 cycles and will be continued if patient tolerates treatments and has stable disease. The Bevacizumab will be continued every 3 weeks for 1 year if the patient tolerates treatment and has stable disease. Carboplatin, Pemetrexed and Bevacizumab: Carboplatin AUC 5 IV day 1 over 30-60 minutes Pemetrexed 500 mg/M2 IV day 1 over 10 minutes Bevacizumab 15 mg /kg IV day over 90 minutes dose 1, 60 minutes dose 2, 30 minutes subsequent doses. Repeat every 3 weeks for total of 6 cycles
Overall Study Adverse Event	3

Baseline Characteristics

Carboplatin, Bevacizumab and Pemetrexed in Advanced Non Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Carboplatin, Bevacicumab, Premetrexed n=50 Participants Patients (age \>18yo) were from 2007 to 2012.. Measurable disease Evaluable disease Stage IV Palliative RT NO brain metastases
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants
Sex: Female, Male SEX · Female	24 Participants n=5 Participants
Sex: Female, Male SEX · Male	26 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
ECOG Performance ECOG Performance Staus Scale 0	6 Participants n=5 Participants
ECOG Performance ECOG Performance Stsus Scale =1	44 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year").

From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year").

Outcome measures

Outcome measures
Measure	Carboplatin, Bevacicumab, Premetrexed n=47 Participants Patients (age \>18yo) were from 2007 to 2012.. 51 patients with nonsquamous stage IV disease were enrolled over 24 months and followed. The meadian follow up was 49 weeks. Of the 51 patient enrolled, 1 patient was with drawn due to ineligibility. Three other patients were not evaluated for response due to adverse reactions.
Progression Free Survival	28 weeks Interval 0.0 to 132.4

PRIMARY outcome

Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year").

Population: Nonsquamous stage IV disease, Male, Female,\>18 years of age, white, african american,with ECOG of 0 or 1

Overal survival was defined as time between the date of treatment assignment and the date of death

Outcome measures

Outcome measures
Measure	Carboplatin, Bevacicumab, Premetrexed n=47 Participants Patients (age \>18yo) were from 2007 to 2012.. 51 patients with nonsquamous stage IV disease were enrolled over 24 months and followed. The meadian follow up was 49 weeks. Of the 51 patient enrolled, 1 patient was with drawn due to ineligibility. Three other patients were not evaluated for response due to adverse reactions.
Overall Survival	49 weeks Interval 0.0 to 62.7

SECONDARY outcome

Timeframe: Patients were enrolled over a 24 month period for treatment visits. After end of treatment visits, subjects were seen or contacted every 3 months for survival data. Median follow up was 49 weeks (6 weeks to death.

Population: Number of Participants with Complete and Partial Tumor Responses

A complete response (CR),was disappearance of all target lesions on CT scan and absence of appearance of any new lesion was required. Partial response (PR) was assessed by at least a 30% decrease in the sum of the longest diameter (LD) of target lesions without appearance of any new lesions. Progressive disease (PD) was defined as at least a 20% increase in the sum of the LD of target lesions or the appearance of one or more new lesions. Patients were assessed to have stable disease if neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD, without appearance of new lesions. Patients who received one or more cycles were evaluable for response.

Outcome measures

Outcome measures
Measure	Carboplatin, Bevacicumab, Premetrexed n=47 Participants Patients (age \>18yo) were from 2007 to 2012.. 51 patients with nonsquamous stage IV disease were enrolled over 24 months and followed. The meadian follow up was 49 weeks. Of the 51 patient enrolled, 1 patient was with drawn due to ineligibility. Three other patients were not evaluated for response due to adverse reactions.
Number of Participants With Complete and Partial Tumor Responses Complete Response	1 Participants
Number of Participants With Complete and Partial Tumor Responses Partial Response	27 Participants

SECONDARY outcome

Timeframe: Subjects were seen or contacted every 3 months with medain follow up of 49 weeks.

Population: four patients discontinued treatment because of treatment related adverse events.

Measured by adverse events such as grade 4 toxicities, hospitalizations for toxicities, fever and neutropenia events, and clinically significant bleeding/thrombotic events.

Outcome measures

Outcome measures
Measure	Carboplatin, Bevacicumab, Premetrexed n=47 Participants Patients (age \>18yo) were from 2007 to 2012.. 51 patients with nonsquamous stage IV disease were enrolled over 24 months and followed. The meadian follow up was 49 weeks. Of the 51 patient enrolled, 1 patient was with drawn due to ineligibility. Three other patients were not evaluated for response due to adverse reactions.
Number of Participants With Adverse Events Thrombocytopenia	1 Participants
Number of Participants With Adverse Events Respiratory distress	1 Participants
Number of Participants With Adverse Events Grade 3 diarrhea	1 Participants
Number of Participants With Adverse Events fatigue	1 Participants

Adverse Events

One Arm for Study

Serious events: 4 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	One Arm for Study n=50 participants at risk Carboplatin, Pemetrexed and Bevacizumab are given day 1 every 3 weeks for 6 cycles and will be continued if patient tolerates treatments and has stable disease. The Bevacizumab will be continued every 3 weeks for 1 year if the patient tolerates treatment and has stable disease. Carboplatin, Pemetrexed and Bevacizumab: Carboplatin AUC 5 IV day 1 over 30-60 minutes Pemetrexed 500 mg/M2 IV day 1 over 10 minutes Bevacizumab 15 mg /kg IV day over 90 minutes dose 1, 60 minutes dose 2, 30 minutes subsequent doses. Repeat every 3 weeks for total of 6 cycles
Blood and lymphatic system disorders Thrombocytopenia	2.0% 1/50 • Number of events 1
Gastrointestinal disorders grade 3 Diarrhea	2.0% 1/50 • Number of events 1
General disorders Fatigue	2.0% 1/50 • Number of events 1
Respiratory, thoracic and mediastinal disorders Respiratory Disease	2.0% 1/50 • Number of events 1

Other adverse events

Other adverse events
Measure	One Arm for Study n=50 participants at risk Carboplatin, Pemetrexed and Bevacizumab are given day 1 every 3 weeks for 6 cycles and will be continued if patient tolerates treatments and has stable disease. The Bevacizumab will be continued every 3 weeks for 1 year if the patient tolerates treatment and has stable disease. Carboplatin, Pemetrexed and Bevacizumab: Carboplatin AUC 5 IV day 1 over 30-60 minutes Pemetrexed 500 mg/M2 IV day 1 over 10 minutes Bevacizumab 15 mg /kg IV day over 90 minutes dose 1, 60 minutes dose 2, 30 minutes subsequent doses. Repeat every 3 weeks for total of 6 cycles
Blood and lymphatic system disorders Neutropenia	6.0% 3/50 • Number of events 3

Additional Information

Dr. Michael Guarino

Christiana Care Health System

Phone: 302 366 1200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place