Trial Outcomes & Findings for Tarceva With Whole Brain Radiation Therapy - Brain Mets From Non-Small Cell Lung Cancer (NCT NCT00871923)

NCT ID: NCT00871923

Last Updated: 2021-09-16

Results Overview

Median Survival will be estimated using the method of Kaplan and Meier (1958) using the intent-to-treat principle.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

44 participants

Primary outcome timeframe

End-of-study visit 1 month after radiation therapy completed, and follow-up visits every 3 months, assessed up to 2 years.

Results posted on

2021-09-16

Participant Flow

A total of 44 patients were consented to this study, but 1 patients withdrew consent prior to protocol treatment. 43 patients was treated under this protocol.

Participant milestones

Participant milestones
Measure	Phase II Tarceva for Brain Metastases in NSCLC Patients were treated with Tarceva 150mg PO daily. On day 7, whole brain radiation 3000cGy/10. remained on Tarceva until disease progression/toxicity
Overall Study STARTED	44
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase II Tarceva for Brain Metastases in NSCLC Patients were treated with Tarceva 150mg PO daily. On day 7, whole brain radiation 3000cGy/10. remained on Tarceva until disease progression/toxicity
Overall Study Death	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Tarceva With Whole Brain Radiation Therapy - Brain Mets From Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase II Tarceva for Brain Metastases in NSCLC n=43 Participants Patients were treated with Tarceva 150mg PO daily. On day 7, whole brain radiation 3000cGy/10. remained on Tarceva until disease progression/toxicity
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=99 Participants
Age, Categorical >=65 years	8 Participants n=99 Participants
Age, Continuous	59 years n=99 Participants
Sex: Female, Male Female	19 Participants n=99 Participants
Sex: Female, Male Male	24 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	2 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	4 Participants n=99 Participants
Race (NIH/OMB) White	32 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=99 Participants
Region of Enrollment United States	42 participants n=99 Participants
Region of Enrollment Mexico	1 participants n=99 Participants
Karnofsky Performance Score (KPS) KPS≥ 80	29 Participants n=99 Participants
Karnofsky Performance Score (KPS) KPS≤ 70	14 Participants n=99 Participants
Tumor Histology Adenocarcinoma	32 Participants n=99 Participants
Tumor Histology Other	9 Participants n=99 Participants
Tumor Histology Squamous	2 Participants n=99 Participants
Smoking History Never	11 Participants n=99 Participants
Smoking History Prior	26 Participants n=99 Participants
Smoking History Current	5 Participants n=99 Participants
Smoking History Unknown	1 Participants n=99 Participants
Previous Therapy Yes	29 Participants n=99 Participants
Previous Therapy No	14 Participants n=99 Participants
Number of Brain Metastases 0-3	19 Participants n=99 Participants
Number of Brain Metastases 4 -10	16 Participants n=99 Participants
Number of Brain Metastases >10	8 Participants n=99 Participants

PRIMARY outcome

Timeframe: End-of-study visit 1 month after radiation therapy completed, and follow-up visits every 3 months, assessed up to 2 years.

Population: Twenty patients from University of Arizona and 20 patients at MDACC for a total of 40 patients were combined for statistical analysis for Median Survival. We excluded 4 MDACC patients because: 1 patients withdrew consent prior to protocol treatment, I patient death during radiotherapy, 2 patients early death without follow-up data.

Median Survival will be estimated using the method of Kaplan and Meier (1958) using the intent-to-treat principle.

Outcome measures

Outcome measures
Measure	Phase II Tarceva for Brain Metastases in NSCLC n=40 Participants Patients were treated with Tarceva 150mg PO daily. On day 7, whole brain radiation 3000cGy/10. remained on Tarceva until disease progression/toxicity
Median Survival	11.8 months Interval 7.4 to 19.1

SECONDARY outcome

Timeframe: From date of registration until the date of first documented death or lost to follow up, whichever came first, assessed up to 2 years.

Overall Survival will be estimated using the method of Kaplan and Meier (1958) using the intent-to-treat principle. The participants overall survival measured at 6 month, 1-year and 2 years.

Outcome measures

Outcome measures
Measure	Phase II Tarceva for Brain Metastases in NSCLC n=40 Participants Patients were treated with Tarceva 150mg PO daily. On day 7, whole brain radiation 3000cGy/10. remained on Tarceva until disease progression/toxicity
Number of Participants With Overall Survival 6-month	27 Participants
Number of Participants With Overall Survival 1-year	20 Participants
Number of Participants With Overall Survival 2-year	7 Participants

Adverse Events

Phase II Tarceva for Brain Metastases in NSCLC

Serious events: 26 serious events

Other events: 0 other events

Deaths: 36 deaths

Serious adverse events

Serious adverse events
Measure	Phase II Tarceva for Brain Metastases in NSCLC n=43 participants at risk Patients were treated with Tarceva 150mg PO daily. On day 7, whole brain radiation 3000cGy/10. remained on Tarceva until disease progression/toxicity
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	9.3% 4/43 • Number of events 5 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed up to 2 years.
Gastrointestinal disorders Nausea	2.3% 1/43 • Number of events 1 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed up to 2 years.
Skin and subcutaneous tissue disorders Acne Rash	14.0% 6/43 • Number of events 6 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed up to 2 years.
Gastrointestinal disorders Dehydration	14.0% 6/43 • Number of events 7 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed up to 2 years.
Congenital, familial and genetic disorders Fatigue	14.0% 6/43 • Number of events 7 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed up to 2 years.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	7.0% 3/43 • Number of events 3 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed up to 2 years.
Musculoskeletal and connective tissue disorders Weakness	11.6% 5/43 • Number of events 5 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed up to 2 years.
Gastrointestinal disorders Upper GI Bleed	2.3% 1/43 • Number of events 1 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed up to 2 years.
Gastrointestinal disorders Vomiting	4.7% 2/43 • Number of events 3 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed up to 2 years.
Gastrointestinal disorders Diarrhea	11.6% 5/43 • Number of events 5 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed up to 2 years.
Hepatobiliary disorders Increased AST/ALT	4.7% 2/43 • Number of events 2 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed up to 2 years.
Hepatobiliary disorders Increased bilirubin	2.3% 1/43 • Number of events 1 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed up to 2 years.
Nervous system disorders Headache	2.3% 1/43 • Number of events 2 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed up to 2 years.
Gastrointestinal disorders Anorexia	4.7% 2/43 • Number of events 2 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed up to 2 years.
Respiratory, thoracic and mediastinal disorders Cough	2.3% 1/43 • Number of events 1 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed up to 2 years.
Respiratory, thoracic and mediastinal disorders Dyspepsia	2.3% 1/43 • Number of events 1 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed up to 2 years.
Respiratory, thoracic and mediastinal disorders Dyspenea	14.0% 6/43 • Number of events 6 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed up to 2 years.
Investigations Weight Loss	2.3% 1/43 • Number of events 1 • From date of protocol registration until the date of documented development of adverse events (AEs) , assessed up to 2 years.

Other adverse events

Adverse event data not reported

Additional Information

James Welsh,MD- Associate Professor, Radiation Oncology Department

UT MD Anderson Cancer Center

Phone: (713) 563-2447

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place