Trial Outcomes & Findings for Erlotinib and Standard Platinum-Based Chemotherapy for Newly Diagnosed, Advanced Non-Small Cell Carcinoma of the Lung (NCT NCT00391586)

NCT ID: NCT00391586

Last Updated: 2015-08-17

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 45 participants
• Primary outcome timeframe: 5 years
• Results posted on: 2015-08-17

Participant Flow

Recruitment began 07/13/2006 and ended 02/09/2009. All patients were recruited through medical clinics in New Mexico, USA.

Participant milestones

Measure	Erlotinib Followed by Chemotherapy Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
Overall Study STARTED	45
Overall Study Received First-line Erlotinib	43
Overall Study Received Platinum-based Chemotherapy	10
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Measure	Erlotinib Followed by Chemotherapy Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
Overall Study Progressive disease	13
Overall Study Adverse Event	5
Overall Study Physician Decision	2
Overall Study Death	4

Baseline Characteristics

Erlotinib and Standard Platinum-Based Chemotherapy for Newly Diagnosed, Advanced Non-Small Cell Carcinoma of the Lung

Baseline characteristics by cohort

Measure	Erlotinib Followed by Chemotherapy n=43 Participants Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
Age, Continuous	68 years n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Population: This study was terminated early; no results are available. The number of patients who completed treatment and therefore the number of evaluable patients was too low to accurately calculate endpoints.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 28 days after last on-study treatment

Toxicities are assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 3.0. Toxicities are reported as the number of patients who experienced grade 3 or grade 4 adverse events after receiving at least one dose of on-study treatment.

Outcome measures

Measure	Erlotinib Followed by Chemotherapy n=43 Participants Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
Toxicity Profile Acne	1 participants
Toxicity Profile Anorexia	1 participants
Toxicity Profile Confusion	1 participants
Toxicity Profile Dehydration	1 participants
Toxicity Profile Diarrhea	2 participants
Toxicity Profile Dyspnea	3 participants
Toxicity Profile Fatigue	8 participants
Toxicity Profile Nasal hemorrhage	1 participants
Toxicity Profile Insomnia	1 participants
Toxicity Profile Kidney pain	1 participants
Toxicity Profile Lymphocyte count decreased	1 participants
Toxicity Profile Muscle weakness	1 participants
Toxicity Profile Neutrophil count decreased	2 participants
Toxicity Profile Desquamating rash	1 participants
Toxicity Profile Syncope	1 participants
Toxicity Profile Thrombosis (clotting)	1 participants

Adverse Events

Erlotinib Followed by Chemotherapy

Serious events: 5 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Measure	Erlotinib Followed by Chemotherapy n=43 participants at risk Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
Endocrine disorders Glucose intolerance	2.3% 1/43 • Number of events 1 • Patients are assessed for toxicity/adverse events for 28 days after completion of the last course of any on-study therapy.
Nervous system disorders Seizure	2.3% 1/43 • Number of events 1 • Patients are assessed for toxicity/adverse events for 28 days after completion of the last course of any on-study therapy.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.3% 1/43 • Number of events 1 • Patients are assessed for toxicity/adverse events for 28 days after completion of the last course of any on-study therapy.
Blood and lymphatic system disorders Thrombosis (Clotting)	2.3% 1/43 • Number of events 1 • Patients are assessed for toxicity/adverse events for 28 days after completion of the last course of any on-study therapy.
General disorders Ear, nose, and throat examination abnormal	2.3% 1/43 • Number of events 1 • Patients are assessed for toxicity/adverse events for 28 days after completion of the last course of any on-study therapy.
General disorders Death	2.3% 1/43 • Number of events 1 • Patients are assessed for toxicity/adverse events for 28 days after completion of the last course of any on-study therapy.

Other adverse events

Measure	Erlotinib Followed by Chemotherapy n=43 participants at risk Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
General disorders Fatigue	30.2% 13/43 • Number of events 25 • Patients are assessed for toxicity/adverse events for 28 days after completion of the last course of any on-study therapy.
General disorders Fever	7.0% 3/43 • Number of events 3 • Patients are assessed for toxicity/adverse events for 28 days after completion of the last course of any on-study therapy.
Skin and subcutaneous tissue disorders Acne	20.9% 9/43 • Number of events 13 • Patients are assessed for toxicity/adverse events for 28 days after completion of the last course of any on-study therapy.
Skin and subcutaneous tissue disorders Alopecia (Hair loss)	11.6% 5/43 • Number of events 5 • Patients are assessed for toxicity/adverse events for 28 days after completion of the last course of any on-study therapy.
Skin and subcutaneous tissue disorders Rash	16.3% 7/43 • Number of events 9 • Patients are assessed for toxicity/adverse events for 28 days after completion of the last course of any on-study therapy.
Gastrointestinal disorders Anorexia (loss of appetite)	18.6% 8/43 • Number of events 13 • Patients are assessed for toxicity/adverse events for 28 days after completion of the last course of any on-study therapy.
Gastrointestinal disorders Constipation	11.6% 5/43 • Number of events 5 • Patients are assessed for toxicity/adverse events for 28 days after completion of the last course of any on-study therapy.
Gastrointestinal disorders Diarrhea	20.9% 9/43 • Number of events 16 • Patients are assessed for toxicity/adverse events for 28 days after completion of the last course of any on-study therapy.
Gastrointestinal disorders Nausea	20.9% 9/43 • Number of events 9 • Patients are assessed for toxicity/adverse events for 28 days after completion of the last course of any on-study therapy.
Gastrointestinal disorders Taste alteration	16.3% 7/43 • Number of events 9 • Patients are assessed for toxicity/adverse events for 28 days after completion of the last course of any on-study therapy.
Gastrointestinal disorders Vomiting	9.3% 4/43 • Number of events 5 • Patients are assessed for toxicity/adverse events for 28 days after completion of the last course of any on-study therapy.
Nervous system disorders Dizziness	7.0% 3/43 • Number of events 3 • Patients are assessed for toxicity/adverse events for 28 days after completion of the last course of any on-study therapy.
Nervous system disorders Insomnia	7.0% 3/43 • Number of events 6 • Patients are assessed for toxicity/adverse events for 28 days after completion of the last course of any on-study therapy.
Nervous system disorders Peripheral sensory neuropathy	7.0% 3/43 • Number of events 4 • Patients are assessed for toxicity/adverse events for 28 days after completion of the last course of any on-study therapy.
General disorders Chest pain	11.6% 5/43 • Number of events 5 • Patients are assessed for toxicity/adverse events for 28 days after completion of the last course of any on-study therapy.
Respiratory, thoracic and mediastinal disorders Cough	9.3% 4/43 • Number of events 4 • Patients are assessed for toxicity/adverse events for 28 days after completion of the last course of any on-study therapy.
Respiratory, thoracic and mediastinal disorders Dyspnea (Shortness of breath)	18.6% 8/43 • Number of events 8 • Patients are assessed for toxicity/adverse events for 28 days after completion of the last course of any on-study therapy.
Respiratory, thoracic and mediastinal disorders Pleural effusion (Fluid collection in lung lining)	7.0% 3/43 • Number of events 3 • Patients are assessed for toxicity/adverse events for 28 days after completion of the last course of any on-study therapy.
Skin and subcutaneous tissue disorders Dry skin	9.3% 4/43 • Number of events 4 • Patients are assessed for toxicity/adverse events for 28 days after completion of the last course of any on-study therapy.

Additional Information

Dennie Jones, MD

Dana Farber Cancer Institute

Phone: 617-632-6478

Email: DennieV_Jones@DFCI.HARVARD.EDU

Results disclosure agreements

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