Last reviewed · How we verify

NCT00871923

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

Completed Phase 2 Results posted Last updated 16 September 2021
What this trial tests

Phase 2 trial testing Tarceva (Erlotinib hydrochloride) in Non-small Cell Lung Cancer in 44 participants. Completed in 4 December 2019.

Timeline
26 March 2009
Primary endpoint
4 December 2019
4 December 2019

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment44
Start date26 March 2009
Primary completion4 December 2019
Estimated completion4 December 2019
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

Adults 18 to 70, any sex, with Non-small Cell Lung Cancer or Brain Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

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

GroupValue95% CI
Phase II Tarceva for Brain Metastases in NSCLC11.87.4 – 19.1
Number of Participants With Overall Survival Secondary · 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.

6-month
GroupValue95% CI
Phase II Tarceva for Brain Metastases in NSCLC27
1-year
GroupValue95% CI
Phase II Tarceva for Brain Metastases in NSCLC20
2-year
GroupValue95% CI
Phase II Tarceva for Brain Metastases in NSCLC7

Adverse events — posted to ClinicalTrials.gov

Time frame: From date of protocol registration until the date of documented development of adverse events (AEs) , assessed up to 2 years.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase II Tarceva for Brain Metastases in NSCLC
Serious: 26/43 (60%)
Deaths: 36/43

Serious adverse events (18 terms)

ReactionSystemPhase II Tarceva for Brain…
Acne RashSkin and subcutaneous tissue disorders
DehydrationGastrointestinal disorders
FatigueCongenital, familial and genetic disorders
DyspeneaRespiratory, thoracic and mediastinal disorders
WeaknessMusculoskeletal and connective tissue disorders
DiarrheaGastrointestinal disorders
Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders
Pleural EffusionRespiratory, thoracic and mediastinal disorders
VomitingGastrointestinal disorders
Increased AST/ALTHepatobiliary disorders
AnorexiaGastrointestinal disorders
NauseaGastrointestinal disorders
Upper GI BleedGastrointestinal disorders
Increased bilirubinHepatobiliary disorders
HeadacheNervous system disorders
CoughRespiratory, thoracic and mediastinal disorders
DyspepsiaRespiratory, thoracic and mediastinal disorders
Weight LossInvestigations

Most-reported serious reactions: Acne Rash, Dehydration, Fatigue, Dyspenea, Weakness, Diarrhea, Pulmonary Embolism, Pleural Effusion.

Data from ClinicalTrials.gov NCT00871923 adverse events section.

Sponsor's own description

The goal of this clinical research study is to learn whether Tarceva (erlotinib hydrochloride), when given in addition to whole brain radiation therapy, is better to treat brain metastases in patients with Non-Small Cell Lung Cancer (NSCLC).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Phase II trial of erlotinib plus concurrent whole-brain radiation therapy for patients with brain metastases from non-small-cell lung cancer.
    Welsh JW, Komaki R, Amini A, Munsell MF, et al · · 2013 · cited 294× · PMID 23341526 · DOI 10.1200/jco.2011.40.1174
  2. Sample size determination and evaluation for two-stage adaptive designs of single arm clinical trials based on median event time test.
    Park Y, Chen Y. · · 2023 · PMID 37941851 · DOI 10.1016/j.conctc.2023.101225

Verify or expand the search:

Other recruiting trials for Non-small Cell Lung Cancer

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00871923.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing