Trial Outcomes & Findings for Carboplatin, Paclitaxel, and Bevacizumab With or Without Erlotinib Hydrochloride in Treating Non-Smokers With Advanced Non-Small Cell Lung Cancer (NCT NCT00976677)

Last Updated: 2014-05-30

Results Overview

Progression-free survival (PFS) is defined to be the time from randomization to progression of disease or death, whichever occurs first. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Every 6 weeks during treatment and every 3 months in follow-up until disease progression or up to 5 years

Results posted on

2014-05-30

Participant Flow

This study opened to accrual on January 27, 2010 and was terminated on May 13, 2011 due to slow accrual. Final accrual was 10 patients.

Participant milestones

Participant milestones
Measure	Arm A Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive placebo (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.	Arm B Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm A. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	5	5
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive placebo (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.	Arm B Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm A. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	0	2
Overall Study Disease progression	1	1
Overall Study Trial unblinded	2	2
Overall Study Unknown/Missing	1	0

Baseline Characteristics

Carboplatin, Paclitaxel, and Bevacizumab With or Without Erlotinib Hydrochloride in Treating Non-Smokers With Advanced Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A n=5 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive placebo (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.	Arm B n=5 Participants Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm A. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.	Total n=10 Participants Total of all reporting groups
Age, Continuous	53 years n=5 Participants	63 years n=7 Participants	62 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Every 6 weeks during treatment and every 3 months in follow-up until disease progression or up to 5 years

Population: All eligible and treated patients are included in this analysis.

Outcome measures

Outcome measures
Measure	Arm A n=5 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive placebo (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.	Arm B n=5 Participants Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm A. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
Progression-free Survival (PFS)	4.5 Months Interval 4.5 to The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.	15.5 Months Interval 6.74 to The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.

Adverse Events

Arm A

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Arm B

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A n=5 participants at risk Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive placebo (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.	Arm B n=5 participants at risk Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm A. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
General disorders Fatigue	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Diarrhea	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	40.0% 2/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Investigations Aspartate aminotransferase increased	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Investigations Lymphocyte count decreased	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Investigations Neutrophil count decreased	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Investigations White blood cell count decreased	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hyponatremia	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Cardiac disorders Hypotension	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.

Other adverse events

Additional Information

Study Statistician

ECOG Statistical Office

Phone: 617-632-3012

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Arm A n=5 participants at risk Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive placebo (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.	Arm B n=5 participants at risk Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm A. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	40.0% 2/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
General disorders Fatigue	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	60.0% 3/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Skin and subcutaneous tissue disorders Rash acneiform	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	40.0% 2/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Diarrhea	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	40.0% 2/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Constipation	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	40.0% 2/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Nausea	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	60.0% 3/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Vomiting	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Investigations Alanine aminotransferase increased	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Investigations Alkaline phosphatase increased	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Investigations Blood bilirubin increased	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Investigations Creatinine increased	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Investigations Neutrophil count decreased	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	40.0% 2/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Investigations Platelet count decreased	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Investigations White blood cell count decreased	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Anorexia	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Nervous system disorders Paresthesia	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Nervous system disorders Peripheral motor neuropathy	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Eye disorders Blurred vision	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	40.0% 2/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Vascular disorders Hypertension	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Abdominal pain	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Gastrointestinal disorders Dry mouth	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hypocalcemia	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hypokalemia	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Metabolism and nutrition disorders Hypomagnesemia	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Nervous system disorders Dizziness	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Nervous system disorders Dysgeusia	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Psychiatric disorders Depression	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	20.0% 1/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.	0.00% 0/5 • Assessed every 21 days while on treatment and for 30 days after the end of treatment.