Trial Outcomes & Findings for Second Line Erlotinib (Tarceva) Plus Digoxin in Non-Small Cell Lung Cancer (NCT NCT00281021)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

26 participants

Primary outcome timeframe

Measured every 6 weeks after baseline until disease progression, an average of 3 months

Results posted on

2018-03-29

Participant Flow

Patient accrual lasted from March 2006 until August 2008 and was stopped early at the time of interim analysis. 24 who completed at least 6 weeks of therapy are presented here.

Participant milestones

Participant milestones
Measure	Erlotinib and Digoxin Erlotinib plus Digoxin Erlotinib plus Digoxin : Each subject will receive erlotinib and digoxin daily until progression.
Overall Study STARTED	26
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Second Line Erlotinib (Tarceva) Plus Digoxin in Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erlotinib and Digoxin n=26 Participants Erlotinib plus Digoxin Erlotinib plus Digoxin : Each subject will receive erlotinib and digoxin daily until progression.
Age, Continuous	61 years n=93 Participants
Age, Customized <=18 years	0 participants n=93 Participants
Age, Customized >18 years	26 participants n=93 Participants
Sex: Female, Male Female	16 Participants n=93 Participants
Sex: Female, Male Male	10 Participants n=93 Participants

PRIMARY outcome

Timeframe: Measured every 6 weeks after baseline until disease progression, an average of 3 months

Outcome measures

Outcome measures
Measure	Erlotinib and Digoxin n=24 Participants Erlotinib plus Digoxin Erlotinib plus Digoxin : Each subject will receive erlotinib and digoxin daily until progression.
Therapeutic Response, Evaluated by Computed Tomography (CT) Scans of Chest & Abdomen. Stable Disease	9 participants
Therapeutic Response, Evaluated by Computed Tomography (CT) Scans of Chest & Abdomen. Partial Response	1 participants
Therapeutic Response, Evaluated by Computed Tomography (CT) Scans of Chest & Abdomen. Progressive Disease	14 participants

Adverse Events

Erlotinib and Digoxin

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Erlotinib and Digoxin n=24 participants at risk Erlotinib plus Digoxin Erlotinib plus Digoxin : Each subject will receive erlotinib and digoxin daily until progression.
Gastrointestinal disorders Diarrhea	54.2% 13/24
General disorders Fatigue	20.8% 5/24
General disorders Rash	41.7% 10/24
Gastrointestinal disorders Nausea	12.5% 3/24
Respiratory, thoracic and mediastinal disorders Dyspnea	8.3% 2/24

Additional Information

Dr. Goetz Kloecker

James Graham Brown Cancer Center, University of Louisville

Phone: 502-562-4358

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place