Trial Outcomes & Findings for Tarceva Surgery for Resectable Stage IIIA(N2) and IIIB (T4 N2) Non-Small-Cell Lung Cancer (NCT NCT00063258)

Last Updated: 2016-05-09

Results Overview

Response defined by tumor assessment using Response Evaluation Criteria In Solid Tumors (RECIST) to learn effectiveness of Tarceva (OSI-774) when combined with standard chemotherapy before surgery.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

5 Years to collect outcome information

Results posted on

2016-05-09

Participant Flow

Recruitment Period: 10/13/2003 to 03/18/2008; All patients recruited at University of Texas M.D. Anderson Cancer Center

Study terminated due to low accrual; No evaluable patients were assigned to Chemotherapy Alone group (anticipated randomization to have been 10 of 40 patients treated with 3 courses of chemotherapy).

Participant milestones

Participant milestones
Measure	Chemotherapy + Tarceva	Chemotherapy Alone
Overall Study STARTED	5	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Chemotherapy + Tarceva	Chemotherapy Alone
Overall Study Physician Decision	2	0
Overall Study Lack of Efficacy	2	0

Baseline Characteristics

Tarceva Surgery for Resectable Stage IIIA(N2) and IIIB (T4 N2) Non-Small-Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemotherapy + Tarceva n=5 Participants	Chemotherapy Alone	Total n=5 Participants Total of all reporting groups
Age, Continuous	64 years n=5 Participants	—	64 years n=5 Participants
Gender Female	1 participants n=5 Participants	—	1 participants n=5 Participants
Gender Male	4 participants n=5 Participants	—	4 participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	—	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 Years to collect outcome information

Population: Analysis limited since of 5 participants enrolled, only 1 evaluable for response.

Response defined by tumor assessment using Response Evaluation Criteria In Solid Tumors (RECIST) to learn effectiveness of Tarceva (OSI-774) when combined with standard chemotherapy before surgery.

Outcome measures

Outcome measures
Measure	Chemotherapy + Tarceva n=1 Participants	Chemotherapy Alone
Number of Patients With Response Complete Response	0 Participants	—
Number of Patients With Response Partial Response	0 Participants	—
Number of Patients With Response Stable Disease	1 Participants	—
Number of Patients With Response Progressive Disease	0 Participants	—

Adverse Events

Chemotherapy + Tarceva

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Chemotherapy Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Chemotherapy + Tarceva n=5 participants at risk	Chemotherapy Alone
Blood and lymphatic system disorders Hemoptysis (Grade 1)	100.0% 1/1 • Number of events 1 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)	— 0/0 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)

Other adverse events

Additional Information

Mellanie Price, B.S.

University of Texas M.D. Anderson Cancer Center

Phone: 713-792-4392

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Chemotherapy + Tarceva n=5 participants at risk	Chemotherapy Alone
Gastrointestinal disorders Abdominal Cramping (Grade 2)	20.0% 1/5 • Number of events 1 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)	— 0/0 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)
Skin and subcutaneous tissue disorders Alopecia (Grade 2)	20.0% 1/5 • Number of events 1 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)	— 0/0 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)
Hepatobiliary disorders Bilirubin Increase (Grade 1)	20.0% 1/5 • Number of events 1 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)	— 0/0 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)
Gastrointestinal disorders Diarrhea (Grade 3)	20.0% 1/5 • Number of events 1 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)	— 0/0 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)
Skin and subcutaneous tissue disorders Dry Skin (Grade 2)	20.0% 1/5 • Number of events 1 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)	— 0/0 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)
Gastrointestinal disorders Dysphagia (Grade 1)	20.0% 1/5 • Number of events 1 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)	— 0/0 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)
General disorders Fatigue (Grade 2)	20.0% 1/5 • Number of events 1 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)	— 0/0 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)
Infections and infestations Infection Clinical with Grade 3-4 ANC (Wound)	20.0% 1/5 • Number of events 1 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)	— 0/0 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)
Infections and infestations Infection with Normal ANC (Bladder -Urinary) Grade 2	20.0% 1/5 • Number of events 1 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)	— 0/0 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)
Infections and infestations Infection with Normal ANC (Wound) Grade 2	20.0% 1/5 • Number of events 1 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)	— 0/0 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)
Musculoskeletal and connective tissue disorders Myalgia (Grade 3)	20.0% 1/5 • Number of events 1 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)	— 0/0 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)
Gastrointestinal disorders Nausea (Grade 1)	20.0% 1/5 • Number of events 1 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)	— 0/0 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)
Gastrointestinal disorders Nausea (Grade 3)	20.0% 1/5 • Number of events 1 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)	— 0/0 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)
Nervous system disorders Neuropathy: Sensory (Grade 1)	20.0% 1/5 • Number of events 1 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)	— 0/0 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)
General disorders Pain (Grade 2)	20.0% 1/5 • Number of events 1 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)	— 0/0 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)
Cardiac disorders Palpitations (Grade 3)	20.0% 1/5 • Number of events 1 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)	— 0/0 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)
Skin and subcutaneous tissue disorders Rash/Desquamation (Grade 3)	20.0% 1/5 • Number of events 1 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)	— 0/0 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)
Gastrointestinal disorders Stomatitis (Grade 2)	20.0% 1/5 • Number of events 1 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)	— 0/0 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)
Gastrointestinal disorders Taste Alteration (Grade 2)	20.0% 1/5 • Number of events 1 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)	— 0/0 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)
Gastrointestinal disorders Vomiting (Grade 2)	20.0% 1/5 • Number of events 1 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)	— 0/0 • Adverse events were collected from study activation (June 17, 2003) to 30 days following last dose of study treatment (approximately 2 years and 5 months)