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Trial Outcomes & Findings for Erlotinib and Chemotherapy for Patients With Stage IB-IIIA NSCLC With EGFR Mutations (ECON) (NCT NCT00577707)

NCT ID: NCT00577707

Last Updated: 2018-01-10

Results Overview

Complete Response (CR): Disappearance of all clinical evidence of tumor. Partial Response (PR): A 50% or greater decrease in the sum of the products of measured lesions. No simultaneous increase in the size of any lesion or the appearance of new lesions may occur. Non-measurable lesions must remain stable or regress for this category. Minor Response (MR): A \> 25% and \< 50% decrease in the sum of the products of measured lesions. No simultaneous increase in the size of any lesion or the appearance of new lesions may occur. Non-measurable lesions must remain stable or regress for this category. Stable Disease (SD): A less than 25% decrease. This includes a decrease of less than 25% in the sum of the products of the measured lesions, and any increase of less than 25% in the sum of the products of the measured lesions. There may be no appearance of new disease sites for this category. Progressive Disease (PD): A ≥25% increase in one or more lesions, or appearance of new lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

Patients will undergo a CT scan of chest every 3 months for year 1 and every 4 months for year 2. In years 3 and 4, a chest CT or chest x-ray every 6 months.

Results posted on

2018-01-10

Participant Flow

Participant milestones

Participant milestones
Measure
Patients With Stage IB-IIIA NSCLC With EGFR Mutations
Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations
Overall Study
STARTED
9
Overall Study
COMPLETED
6
Overall Study
NOT COMPLETED
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Patients With Stage IB-IIIA NSCLC With EGFR Mutations
Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations
Overall Study
Withdrawal by Subject
3

Baseline Characteristics

Erlotinib and Chemotherapy for Patients With Stage IB-IIIA NSCLC With EGFR Mutations (ECON)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Patients With Stage IB-IIIA NSCLC With EGFR Mutations
n=9 Participants
Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
4 Participants
n=5 Participants
Age, Categorical
>=65 years
5 Participants
n=5 Participants
Sex: Female, Male
Female
8 Participants
n=5 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Patients will undergo a CT scan of chest every 3 months for year 1 and every 4 months for year 2. In years 3 and 4, a chest CT or chest x-ray every 6 months.

Complete Response (CR): Disappearance of all clinical evidence of tumor. Partial Response (PR): A 50% or greater decrease in the sum of the products of measured lesions. No simultaneous increase in the size of any lesion or the appearance of new lesions may occur. Non-measurable lesions must remain stable or regress for this category. Minor Response (MR): A \> 25% and \< 50% decrease in the sum of the products of measured lesions. No simultaneous increase in the size of any lesion or the appearance of new lesions may occur. Non-measurable lesions must remain stable or regress for this category. Stable Disease (SD): A less than 25% decrease. This includes a decrease of less than 25% in the sum of the products of the measured lesions, and any increase of less than 25% in the sum of the products of the measured lesions. There may be no appearance of new disease sites for this category. Progressive Disease (PD): A ≥25% increase in one or more lesions, or appearance of new lesions.

Outcome measures

Outcome measures
Measure
Patients With Stage IB-IIIA NSCLC With EGFR Mutations
n=6 Participants
Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations
Number of Patients With Pathologic Complete Response Rate
Stable Disease (SD)
2 participants
Number of Patients With Pathologic Complete Response Rate
Minor Response (MR)
1 participants
Number of Patients With Pathologic Complete Response Rate
Partial Response (PR)
1 participants
Number of Patients With Pathologic Complete Response Rate
Progressive Disease (POD)
2 participants

SECONDARY outcome

Timeframe: calculate the response rate after 21 days of single agent erlotinib

Population: Data was not collected because of lack of accrual.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Population: Data was not collected because of lack of accrual.

Outcome measures

Outcome data not reported

Adverse Events

Patients With Stage IB-IIIA NSCLC With EGFR Mutations

Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Patients With Stage IB-IIIA NSCLC With EGFR Mutations
n=6 participants at risk
Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations
Gastrointestinal disorders
Diarrhea
16.7%
1/6 • Number of events 1
General disorders
Nausea
16.7%
1/6 • Number of events 1
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
16.7%
1/6 • Number of events 1
Gastrointestinal disorders
Vomiting
16.7%
1/6 • Number of events 1

Other adverse events

Other adverse events
Measure
Patients With Stage IB-IIIA NSCLC With EGFR Mutations
n=6 participants at risk
Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations
Blood and lymphatic system disorders
ALT, SGPT
16.7%
1/6 • Number of events 1
Blood and lymphatic system disorders
AST, SGOT
16.7%
1/6 • Number of events 1
Metabolism and nutrition disorders
Albumin, low (hypoalbuminemia)
16.7%
1/6 • Number of events 1
Metabolism and nutrition disorders
Alkaline phosphatase
16.7%
1/6 • Number of events 1
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
16.7%
1/6 • Number of events 1
Blood and lymphatic system disorders
Creatinine
16.7%
1/6 • Number of events 1
General disorders
Dehydration
16.7%
1/6 • Number of events 1
Gastrointestinal disorders
Diarrhea
50.0%
3/6 • Number of events 3
General disorders
Dizziness
16.7%
1/6 • Number of events 1
General disorders
Fatigue (asthenia, lethargy, malaise)
50.0%
3/6 • Number of events 5
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
50.0%
3/6 • Number of events 3
Blood and lymphatic system disorders
Hemoglobin
66.7%
4/6 • Number of events 4
Blood and lymphatic system disorders
Lymphopenia
16.7%
1/6 • Number of events 1
General disorders
Mucositis (Clin exam)- Oral cavity
33.3%
2/6 • Number of events 2
General disorders
Nausea
16.7%
1/6 • Number of events 2
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
33.3%
2/6 • Number of events 2
Skin and subcutaneous tissue disorders
Rash/desquamation
16.7%
1/6 • Number of events 1
Skin and subcutaneous tissue disorders
Rash: erythema multiforme
16.7%
1/6 • Number of events 1
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
33.3%
2/6 • Number of events 2
General disorders
Sweating (diaphoresis)
16.7%
1/6 • Number of events 1
Ear and labyrinth disorders
Tinnitus
16.7%
1/6 • Number of events 2

Additional Information

Dr. Mark Kris

Memorial Sloan Kettering Cancer Center

Phone: 646-888-4205

Results disclosure agreements

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