Trial Outcomes & Findings for S0635: Erlotinib and Bevacizumab in Stage IIIB and IV Bronchioloalveolar Carcinoma (NCT NCT00436332)

NCT ID: NCT00436332

Last Updated: 2020-04-02

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 84 participants
• Primary outcome timeframe: From date of registration to maximum of 3 years
• Results posted on: 2020-04-02

Participant Flow

Participant milestones

Measure	Erlotinib and Bevacizumab Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
Overall Study STARTED	84
Overall Study Eligible	82
Overall Study Eligible and Began Protocol Therapy	79
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	83

Reasons for withdrawal

Measure	Erlotinib and Bevacizumab Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
Overall Study Adverse Event	9
Overall Study Withdrawal by Subject	2
Overall Study Progression	59
Overall Study Death	2
Overall Study Not Protocol Specified	6
Overall Study Ineligible	2
Overall Study Never Received Treatment	3

Baseline Characteristics

S0635: Erlotinib and Bevacizumab in Stage IIIB and IV Bronchioloalveolar Carcinoma

Baseline characteristics by cohort

Measure	Erlotinib and Bevacizumab n=79 Participants Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
Age, Continuous	69.2 years n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	73 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 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	6 Participants n=5 Participants
Race (NIH/OMB) White	72 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Histology Adenocarcinoma with Bronchioloalveolar Carcinoma	56 Participants n=5 Participants
Histology Bronchioloalveolar Carcinoma	23 Participants n=5 Participants
Performance Status 0	37 Participants n=5 Participants
Performance Status 1	39 Participants n=5 Participants
Performance Status 2	3 Participants n=5 Participants
Smoking History Current	11 Participants n=5 Participants
Smoking History Former	61 Participants n=5 Participants
Smoking History Never	7 Participants n=5 Participants
Stage IIIB	3 Participants n=5 Participants
Stage IV	76 Participants n=5 Participants
Weight Loss Last 6 Months <5%	57 Participants n=5 Participants
Weight Loss Last 6 Months 5-<10%	8 Participants n=5 Participants
Weight Loss Last 6 Months 10-20%	10 Participants n=5 Participants
Weight Loss Last 6 Months Unknown	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of registration to maximum of 3 years

Outcome measures

Measure	Erlotinib and Bevacizumab n=79 Participants Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
Overall Survival	21 months Interval 14.0 to 26.0

SECONDARY outcome

Timeframe: From date of registration to maximum of 3 years

Outcome measures

Measure	Erlotinib and Bevacizumab n=79 Participants Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
Progression-free Survival	5 months Interval 4.0 to 7.0

SECONDARY outcome

Timeframe: From date of registration to maximum of 3 years

Images for response assessed by the central computer-assisted image-analysis system were never collected.

Outcome measures

Measure	Erlotinib and Bevacizumab n=79 Participants Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
Response as Assessed by RECIST Criteria vs Central Computer-assisted Image-analysis System in Patients With Measurable Disease Confirmed Complete Response	2 Participants
Response as Assessed by RECIST Criteria vs Central Computer-assisted Image-analysis System in Patients With Measurable Disease Confirmed Partial Response	5 Participants
Response as Assessed by RECIST Criteria vs Central Computer-assisted Image-analysis System in Patients With Measurable Disease Unconfirmed Partial Response	8 Participants
Response as Assessed by RECIST Criteria vs Central Computer-assisted Image-analysis System in Patients With Measurable Disease Stable/No Response	33 Participants
Response as Assessed by RECIST Criteria vs Central Computer-assisted Image-analysis System in Patients With Measurable Disease Progression	11 Participants
Response as Assessed by RECIST Criteria vs Central Computer-assisted Image-analysis System in Patients With Measurable Disease Symptomatic Deterioration	1 Participants
Response as Assessed by RECIST Criteria vs Central Computer-assisted Image-analysis System in Patients With Measurable Disease Early Death	1 Participants
Response as Assessed by RECIST Criteria vs Central Computer-assisted Image-analysis System in Patients With Measurable Disease Assessment Inadequate	2 Participants
Response as Assessed by RECIST Criteria vs Central Computer-assisted Image-analysis System in Patients With Measurable Disease Non Measurable Baseline Disease Status	16 Participants

SECONDARY outcome

Timeframe: From date of registration to maximum of 3 years

Population: Number of Subjects With Greater Than Grade 2 Toxicity

Outcome measures

Measure	Erlotinib and Bevacizumab n=79 Participants Patients receive 150 mg of erlotinib daily and 15 mg/kg of bevacizumab on day one of the 21-day cycle.
Frequency and Severity of Toxicities AST, SGOT	1 participants
Frequency and Severity of Toxicities Albumin, serum-low (hypoalbuminemia)	1 participants
Frequency and Severity of Toxicities Anorexia	2 participants
Frequency and Severity of Toxicities Ataxia (incoordination)	1 participants
Frequency and Severity of Toxicities CNS cerebrovascular ischemia	3 participants
Frequency and Severity of Toxicities Carbon monoxide diffusion capacity (DL(co))	1 participants
Frequency and Severity of Toxicities Creatinine	1 participants
Frequency and Severity of Toxicities Dehydration	3 participants
Frequency and Severity of Toxicities Diarrhea	12 participants
Frequency and Severity of Toxicities Dry skin	1 participants
Frequency and Severity of Toxicities Dyspnea (shortness of breath)	2 participants
Frequency and Severity of Toxicities Extremity-lower (gait/walking)	1 participants
Frequency and Severity of Toxicities Fatigue (asthenia, lethargy, malaise)	9 participants
Frequency and Severity of Toxicities Hypertension	6 participants
Frequency and Severity of Toxicities Hypoxia	2 participants
Frequency and Severity of Toxicities Inf w/normal ANC or Gr 1-2 neutrophils - Lung	2 participants
Frequency and Severity of Toxicities Left ventricular diastolic dysfunction	1 participants
Frequency and Severity of Toxicities Left ventricular systolic dysfunction	1 participants
Frequency and Severity of Toxicities Mucositis/stomatitis (clinical exam) - Oral cavity	1 participants
Frequency and Severity of Toxicities Mucositis/stomatitis (functional/symp) - Oral cav	1 participants
Frequency and Severity of Toxicities Muscle weakness, not d/t neuropathy - body/general	2 participants
Frequency and Severity of Toxicities Nail changes	1 participants
Frequency and Severity of Toxicities Nausea	2 participants
Frequency and Severity of Toxicities Ocular/Visual-Other (Specify)	1 participants
Frequency and Severity of Toxicities Pain - Chest wall	1 participants
Frequency and Severity of Toxicities Pain - Extremity-limb	1 participants
Frequency and Severity of Toxicities Pain - Head/headache	2 participants
Frequency and Severity of Toxicities Potassium, serum-high (hyperkalemia)	1 participants
Frequency and Severity of Toxicities Potassium, serum-low (hypokalemia)	3 participants
Frequency and Severity of Toxicities Proteinuria	3 participants
Frequency and Severity of Toxicities Pruritus/itching	2 participants
Frequency and Severity of Toxicities Pulmonary/Upper Respiratory-Other (Specify)	1 participants
Frequency and Severity of Toxicities Rash/desquamation	5 participants
Frequency and Severity of Toxicities Rash: acne/acneiform	9 participants
Frequency and Severity of Toxicities Rash: hand-foot skin reaction	4 participants
Frequency and Severity of Toxicities Renal failure	1 participants
Frequency and Severity of Toxicities Renal/Genitourinary-Other (Specify)	1 participants
Frequency and Severity of Toxicities Retinal detachment	1 participants
Frequency and Severity of Toxicities Sodium, serum-low (hyponatremia)	2 participants
Frequency and Severity of Toxicities Speech impairment (e.g., dysphasia or aphasia)	1 participants
Frequency and Severity of Toxicities Syncope (fainting)	1 participants
Frequency and Severity of Toxicities Ulcer, GI - Duodenum	1 participants
Frequency and Severity of Toxicities Ulcer, GI - Stomach	1 participants
Frequency and Severity of Toxicities Ulceration	1 participants
Frequency and Severity of Toxicities Vomiting	1 participants
Frequency and Severity of Toxicities Weight loss	3 participants
Frequency and Severity of Toxicities Wound complication, non-infectious	1 participants

Adverse Events

Erlotinib and Bevacizumab

Serious events: 6 serious events

Other events: 77 other events

Deaths: 56 deaths

Serious adverse events

Measure	Erlotinib and Bevacizumab n=79 participants at risk Patients receive oral erlotinib hydrochloride once daily on days 1-21 and bevacizumab IV over 30-90 minutes on day 1.
Cardiac disorders Left ventricular diastolic dysfunction	1.3% 1/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Eye disorders Retinal detachment	1.3% 1/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Gastrointestinal disorders Ulcer, GI - Stomach	1.3% 1/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Infections and infestations Inf w/normal ANC or Gr 1-2 neutrophils - Lung	1.3% 1/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Investigations Carbon monoxide diffusion capacity (DL(co))	1.3% 1/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Investigations Creatinine	1.3% 1/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Nervous system disorders Speech impairment (e.g., dysphasia or aphasia)	1.3% 1/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Respiratory, thoracic and mediastinal disorders Carbon monoxide diffusion capacity (DL(co))	1.3% 1/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	1.3% 1/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.3% 1/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Skin and subcutaneous tissue disorders Ulceration	1.3% 1/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.

Other adverse events

Measure	Erlotinib and Bevacizumab n=79 participants at risk Patients receive oral erlotinib hydrochloride once daily on days 1-21 and bevacizumab IV over 30-90 minutes on day 1.
Blood and lymphatic system disorders Hemoglobin	19.0% 15/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Eye disorders Dry eye syndrome	7.6% 6/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Gastrointestinal disorders Constipation	16.5% 13/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Gastrointestinal disorders Diarrhea	70.9% 56/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Gastrointestinal disorders Heartburn/dyspepsia	13.9% 11/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam) - Oral cavity	16.5% 13/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Gastrointestinal disorders Mucositis/stomatitis (functional/symp) - Oral cav	15.2% 12/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Gastrointestinal disorders Nausea	39.2% 31/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Gastrointestinal disorders Vomiting	15.2% 12/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
General disorders Edema: limb	5.1% 4/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
General disorders Fatigue (asthenia, lethargy, malaise)	69.6% 55/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
General disorders Rigors/chills	5.1% 4/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	13.9% 11/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Investigations AST, SGOT	22.8% 18/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Investigations Alkaline phosphatase	10.1% 8/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Investigations Bilirubin (hyperbilirubinemia)	22.8% 18/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Investigations Creatinine	17.7% 14/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Investigations Leukocytes (total WBC)	5.1% 4/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Investigations Metabolic/Laboratory-Other	7.6% 6/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Investigations Weight loss	36.7% 29/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	20.3% 16/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Metabolism and nutrition disorders Anorexia	35.4% 28/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	6.3% 5/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Metabolism and nutrition disorders Dehydration	10.1% 8/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	8.9% 7/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	12.7% 10/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	16.5% 13/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Musculoskeletal and connective tissue disorders Muscle weakness, not d/t neuropathy - body/general	8.9% 7/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Musculoskeletal and connective tissue disorders Pain - Extremity-limb	6.3% 5/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Musculoskeletal and connective tissue disorders Pain - Joint	10.1% 8/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Musculoskeletal and connective tissue disorders Pain - Muscle	6.3% 5/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Nervous system disorders Dizziness	8.9% 7/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Nervous system disorders Neuropathy: sensory	8.9% 7/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Nervous system disorders Pain - Head/headache	11.4% 9/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Nervous system disorders Taste alteration (dysgeusia)	19.0% 15/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Psychiatric disorders Insomnia	5.1% 4/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Renal and urinary disorders Proteinuria	21.5% 17/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	10.1% 8/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Respiratory, thoracic and mediastinal disorders Cough	15.2% 12/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	17.7% 14/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory - Nose	32.9% 26/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory-Other	6.3% 5/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria	13.9% 11/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Skin and subcutaneous tissue disorders Dry skin	22.8% 18/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Skin and subcutaneous tissue disorders Hair loss/Alopecia (scalp or body)	29.1% 23/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Skin and subcutaneous tissue disorders Nail changes	6.3% 5/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Skin and subcutaneous tissue disorders Pruritus/itching	22.8% 18/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Skin and subcutaneous tissue disorders Rash/desquamation	35.4% 28/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	73.4% 58/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	13.9% 11/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
Vascular disorders Hypertension	26.6% 21/79 • From date of registration to maximum of 3 years. Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.

Additional Information

Lung Committee Statistician

SWOG Statistical Center

Phone: 206-667-6197

Email: jmoon@fhcrc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place