Trial Outcomes & Findings for Neoadjuvant IRESSA As Single Agent PreopTherapy for NSCLC With Molecular Correlates (NCT NCT00104728)

Results Overview

Objective Response Rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Investigators planned to use this pilot study of neoadjuvant ZD1839 in patients with resectable NSCLC to specifically correlate molecular parameters to the primary clinical study endpoint clinical response assessed by CT response and PET scan response of the primary tumor.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

42 participants

Primary outcome timeframe

3 years

Results posted on

2012-10-31

Participant Flow

Participant milestones

Participant milestones
Measure	Neoadjuvant ZD1839 Preoperative Therapy The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food. At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth. ZD1839 :
Overall Study STARTED	42
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Neoadjuvant ZD1839 Preoperative Therapy The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food. At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth. ZD1839 :
Overall Study screen failures	19

Baseline Characteristics

Neoadjuvant IRESSA As Single Agent PreopTherapy for NSCLC With Molecular Correlates

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neoadjuvant ZD1839 Preoperative Therapy n=42 Participants The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food. At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth. ZD1839 :
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants 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

PRIMARY outcome

Timeframe: 3 years

Objective Response Rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Investigators planned to use this pilot study of neoadjuvant ZD1839 in patients with resectable NSCLC to specifically correlate molecular parameters to the primary clinical study endpoint clinical response assessed by CT response and PET scan response of the primary tumor.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Review of adverse events utilizing Common Toxicity Criteria (CTC) V3. To estimate the safety, tolerability, and feasibility of preoperative ZD1839 in patients with resectable Stage IA/IB, II and selected IIIA NSCLC by evaluating toxicity and operability after preoperative ZD1839.

Outcome measures

Outcome data not reported

Adverse Events

Neoadjuvant ZD1839 Preoperative Therapy

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Neoadjuvant ZD1839 Preoperative Therapy n=42 participants at risk The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food. At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth. ZD1839 :
Gastrointestinal disorders Constipation - unlikely to be related	2.4% 1/42 • Number of events 1 • 3 years
Gastrointestinal disorders Nausea - unlikely to be related	2.4% 1/42 • Number of events 1 • 3 years
General disorders Pain - Abdomen - NOS - unlikely to be related	2.4% 1/42 • Number of events 1 • 3 years
Respiratory, thoracic and mediastinal disorders Pneumothorax - unrelated	2.4% 1/42 • Number of events 2 • 3 years
Cardiac disorders Supraventricular and nodal arrhythmia - Atrial fibrillation - unrelated	2.4% 1/42 • Number of events 1 • 3 years

Additional Information

Dr. Eric Haura

H. Lee Moffitt Cancer Center and Research Institute

Phone: 813-745-6826

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place