Trial Outcomes & Findings for Study of Tarceva and Targretin Oral Capsules in Patients With Advanced Lung Cancer (NCT NCT00125359)

Last Updated: 2019-01-08

Results Overview

Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

42 participants

Primary outcome timeframe

Through study completion, an average of 1 year

Results posted on

2019-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm Erlotinib + Bexarotene All eligible patients will receive continuous daily oral erlotinib 150mg with daily bexarotene oral capsules 400mg. erlotinib and bexarotene: Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg.
Overall Study STARTED	42
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm Erlotinib + Bexarotene All eligible patients will receive continuous daily oral erlotinib 150mg with daily bexarotene oral capsules 400mg. erlotinib and bexarotene: Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg.
Overall Study Death	4
Overall Study Adverse Event	5
Overall Study Physician Decision	14

Baseline Characteristics

Study of Tarceva and Targretin Oral Capsules in Patients With Advanced Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm Erlotinib + Bexarotene n=42 Participants All eligible patients will receive continuous daily oral erlotinib 150mg with daily bexarotene oral capsules 400mg. erlotinib and bexarotene: Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg.
Age, Continuous	67 years n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants
Disease Stage IV	42 Participants n=5 Participants
Histopathology Adenocarcinomas	28 participants n=5 Participants
Histopathology Bronchioloalveolar type	5 participants n=5 Participants
Histopathology Squamous cell carcinoma	2 participants n=5 Participants
Histopathology Non-small cell carcinomas not otherwise specified	10 participants n=5 Participants
Prior anti-EGFR therapy Received prior anti-EGFR therapy	9 Participants n=5 Participants
Prior anti-EGFR therapy Did not receive prior anti-EGFR therapy	33 Participants n=5 Participants
Number of prior chemotherapies	2 chemotherapies n=5 Participants
Smoking status Never smoker	7 Participants n=5 Participants
Smoking status Current smoker	6 Participants n=5 Participants
Smoking status Former smoker	29 Participants n=5 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 1 year

Outcome measures

Outcome measures
Measure	Single Arm Erlotinib + Bexarotene n=19 Participants All eligible patients will receive continuous daily oral erlotinib 150mg with daily bexarotene oral capsules 400mg. erlotinib and bexarotene: Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg.
Radiographic Response Rates	19 Participants

SECONDARY outcome

Timeframe: Through study completion, an average of 1 year

Population: Number of participants analyzed is reported per achieved disease response noted in individual rows.

PET response is assessed based on the guidelines of the European Organization for Research and Treatment of Cancer (EORTC) PET Study Group (Eur J Cancer 1999; 35(13):1773-82). PET response refers to the presence and measurement of the most current PET scan imaging when compared to baseline imaging. The amount of reduction in the disease from baseline to current imaging determines the extent to which the cancer has responded to treatment. Radiographic response is per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Outcome measures

Outcome measures
Measure	Single Arm Erlotinib + Bexarotene n=14 Participants All eligible patients will receive continuous daily oral erlotinib 150mg with daily bexarotene oral capsules 400mg. erlotinib and bexarotene: Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg.
Correlation of Early PET Responses With Objective Radiographic Responses. Computed tomography complete response · Early PET metabolic response	1 Participants
Correlation of Early PET Responses With Objective Radiographic Responses. Computed tomography complete response · Early PET metabolic progression	0 Participants
Correlation of Early PET Responses With Objective Radiographic Responses. Computed tomography complete response · Early PET stable disease	0 Participants
Correlation of Early PET Responses With Objective Radiographic Responses. Computed tomography complete response · Early PET progression	0 Participants
Correlation of Early PET Responses With Objective Radiographic Responses. Computed tomography partial response · Early PET metabolic response	0 Participants
Correlation of Early PET Responses With Objective Radiographic Responses. Computed tomography partial response · Early PET metabolic progression	1 Participants
Correlation of Early PET Responses With Objective Radiographic Responses. Computed tomography partial response · Early PET stable disease	0 Participants
Correlation of Early PET Responses With Objective Radiographic Responses. Computed tomography partial response · Early PET progression	0 Participants
Correlation of Early PET Responses With Objective Radiographic Responses. Computed tomography stable disease · Early PET metabolic response	0 Participants
Correlation of Early PET Responses With Objective Radiographic Responses. Computed tomography stable disease · Early PET metabolic progression	0 Participants
Correlation of Early PET Responses With Objective Radiographic Responses. Computed tomography stable disease · Early PET stable disease	1 Participants
Correlation of Early PET Responses With Objective Radiographic Responses. Computed tomography stable disease · Early PET progression	1 Participants
Correlation of Early PET Responses With Objective Radiographic Responses. Computed tomography disease progression · Early PET metabolic response	0 Participants
Correlation of Early PET Responses With Objective Radiographic Responses. Computed tomography disease progression · Early PET metabolic progression	0 Participants
Correlation of Early PET Responses With Objective Radiographic Responses. Computed tomography disease progression · Early PET stable disease	5 Participants
Correlation of Early PET Responses With Objective Radiographic Responses. Computed tomography disease progression · Early PET progression	5 Participants

SECONDARY outcome

Timeframe: Through study completion, an average of 1 year

Outcome measures

Outcome measures
Measure	Single Arm Erlotinib + Bexarotene n=40 Participants All eligible patients will receive continuous daily oral erlotinib 150mg with daily bexarotene oral capsules 400mg. erlotinib and bexarotene: Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg.
Progression-free Survival and Overall Survival Time to progression	7 Weeks Interval 1.0 to 274.0
Progression-free Survival and Overall Survival Overall survival	22 Weeks Interval 1.0 to 274.0

SECONDARY outcome

Timeframe: Through study completion, an average of 1 year

Population: Three patients had biopsies evaluated for EGFR mutations.

Outcome measures

Outcome measures
Measure	Single Arm Erlotinib + Bexarotene n=3 Participants All eligible patients will receive continuous daily oral erlotinib 150mg with daily bexarotene oral capsules 400mg. erlotinib and bexarotene: Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg.
Evaluation of EGFR Mutations in Tumor Biopsies and Correlation of EGFR Mutations With Objective Radiographic Responses. Complete Response (CR) in EGFR Wild-Type	0 Participants
Evaluation of EGFR Mutations in Tumor Biopsies and Correlation of EGFR Mutations With Objective Radiographic Responses. Partial Response in EGFR Wild-Type	2 Participants
Evaluation of EGFR Mutations in Tumor Biopsies and Correlation of EGFR Mutations With Objective Radiographic Responses. CR in Activating EGFR mutation at exon 21	1 Participants
Evaluation of EGFR Mutations in Tumor Biopsies and Correlation of EGFR Mutations With Objective Radiographic Responses. PR in Activating EGFR mutation at exon 21	0 Participants

Adverse Events

Single Arm Erlotinib + Bexarotene

Serious events: 30 serious events

Other events: 14 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm Erlotinib + Bexarotene n=42 participants at risk All eligible patients will receive continuous daily oral erlotinib 150mg with daily bexarotene oral capsules 400mg. erlotinib and bexarotene: Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg.
Respiratory, thoracic and mediastinal disorders Dyspnea	14.3% 6/42
Respiratory, thoracic and mediastinal disorders Pleural effusion	7.1% 3/42
Cardiac disorders Chest pain	2.4% 1/42
Cardiac disorders Pericardial effusion	4.8% 2/42
Respiratory, thoracic and mediastinal disorders Hemoptysis	7.1% 3/42
Psychiatric disorders Anxiety Disorder	2.4% 1/42
Respiratory, thoracic and mediastinal disorders Post-obstructive Pneumonia	4.8% 2/42
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	4.8% 2/42
Infections and infestations Bacterial pneumonia	2.4% 1/42
Psychiatric disorders Mental status changes	2.4% 1/42
Respiratory, thoracic and mediastinal disorders Pneumonia	4.8% 2/42
Respiratory, thoracic and mediastinal disorders Pulmonary Hemorrhage	2.4% 1/42
Musculoskeletal and connective tissue disorders Back pain	2.4% 1/42
Musculoskeletal and connective tissue disorders Pain	2.4% 1/42
Cardiac disorders Atrial fibrillation	2.4% 1/42
Respiratory, thoracic and mediastinal disorders Declining respiratory status	2.4% 1/42
Renal and urinary disorders Acute renal failure	2.4% 1/42

Other adverse events

Other adverse events
Measure	Single Arm Erlotinib + Bexarotene n=42 participants at risk All eligible patients will receive continuous daily oral erlotinib 150mg with daily bexarotene oral capsules 400mg. erlotinib and bexarotene: Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg.
Psychiatric disorders Hallucinations	2.4% 1/42
General disorders Fatigue	7.1% 3/42
Investigations INR increased	2.4% 1/42
Metabolism and nutrition disorders Hypertriglyceridemia	11.9% 5/42 • Number of events 16
Investigations Activated partial thromboplastin time prolonged	2.4% 1/42
Blood and lymphatic system disorders Increased white blood cell count	2.4% 1/42
Investigations Investigations - Other, elevated granulocytes	2.4% 1/42
Metabolism and nutrition disorders Hypernatremia	2.4% 1/42
Musculoskeletal and connective tissue disorders Proximal muscle weakness	2.4% 1/42
Blood and lymphatic system disorders Neutrophil count decreased	2.4% 1/42
Investigations Cholesterol high	2.4% 1/42
Gastrointestinal disorders Mouth sores	2.4% 1/42
Musculoskeletal and connective tissue disorders Arm pain	2.4% 1/42

Additional Information

Konstantin Dragnev, MD

Dartmouth-Hitchcock Medical Center

Phone: 603-650-6344

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place