Trial Outcomes & Findings for OSI-774 in African American Patients With Advanced and Previously Treated Non-Small Cell Lung Cancer (NCT NCT00230126)

NCT ID: NCT00230126

Last Updated: 2017-12-26

Results Overview

no progression of disease at 12 weeks from starting treatment

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 57 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2017-12-26

Participant Flow

Participant milestones

Measure	Arm A: Erlotinib 150 mg/Day 150 mg/day cycles 1 - 3 erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day.	Arm B: Erlotinib 150 to 200 mg/Day Depending on Body Weight; C Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to generate skin rash. erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day.
Overall Study STARTED	30	28
Overall Study COMPLETED	28	27
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

OSI-774 in African American Patients With Advanced and Previously Treated Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Arm A: 150 mg/Day n=28 Participants 150 mg/day erlotinib: Arm A: 150 mg/day Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day.	Arm B: Cycle 1 - 150-200 mg/Day Depending on Body Weight n=27 Participants Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to generate skin rash. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day.	Total n=55 Participants Total of all reporting groups
Age, Continuous	63 years n=5 Participants	59 years n=7 Participants	62 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

no progression of disease at 12 weeks from starting treatment

Outcome measures

Measure	Erlotinib: Arm A: 150 mg/Day Cycles 1 - 3. n=26 Participants 150 mg/day cycles 1 - 3 erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day.	Arm B: Cycle 1 - 175 or 200 mg/Day Depending on Body Weight; C n=26 Participants Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to generate skin rash. erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day.
Disease Control Rate at 12 Weeks	6 participants	6 participants

PRIMARY outcome

Timeframe: Every 12 weeks

Outcome measures

Measure	Erlotinib: Arm A: 150 mg/Day Cycles 1 - 3. n=26 Participants 150 mg/day cycles 1 - 3 erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day.	Arm B: Cycle 1 - 175 or 200 mg/Day Depending on Body Weight; C n=26 Participants Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to generate skin rash. erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day.
Time to Progression	2.8 months Interval 2.5 to 3.1	2.4 months Interval 1.5 to 2.7

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	Erlotinib: Arm A: 150 mg/Day Cycles 1 - 3. n=26 Participants 150 mg/day cycles 1 - 3 erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day.	Arm B: Cycle 1 - 175 or 200 mg/Day Depending on Body Weight; C n=26 Participants Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to generate skin rash. erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day.
1-year Survival Rate	30 percentage of patients	26 percentage of patients

Adverse Events

Arm A: 150 mg/Day Cycles 1 - 3

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Arm B: Cycle 1 - 175 or 200 mg/Day Depending on Body Weight; C

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm A: 150 mg/Day Cycles 1 - 3 n=28 participants at risk 150 mg/day cycles 1 - 3 erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day.	Arm B: Cycle 1 - 175 or 200 mg/Day Depending on Body Weight; C n=27 participants at risk Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to generate skin rash. erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day.
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.6% 1/28 • 1 year	0.00% 0/27 • 1 year

Other adverse events

Measure	Arm A: 150 mg/Day Cycles 1 - 3 n=28 participants at risk 150 mg/day cycles 1 - 3 erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day.	Arm B: Cycle 1 - 175 or 200 mg/Day Depending on Body Weight; C n=27 participants at risk Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to generate skin rash. erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day.
Skin and subcutaneous tissue disorders rash	67.9% 19/28 • 1 year	70.4% 19/27 • 1 year
Gastrointestinal disorders Nausea/vomitting	7.1% 2/28 • 1 year	22.2% 6/27 • 1 year
Gastrointestinal disorders diarrhea	32.1% 9/28 • 1 year	25.9% 7/27 • 1 year
Gastrointestinal disorders anorexia	32.1% 9/28 • 1 year	25.9% 7/27 • 1 year

Additional Information

Miguel Villalona

The Ohio State University

Phone: 614-366-5068

Email: miguel.villalona@osumc.edu

Results disclosure agreements

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

Restriction type: LTE60