Ph II Gemcitabine, Erlotinib, and Gemcitabine With Erlotinib/Elderly Patients W/ IIIB/IV NSCLC
NCT ID: NCT00283244
Last Updated: 2017-04-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
147 participants
INTERVENTIONAL
2006-03-31
2014-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This randomized phase II trial is studying gemcitabine and erlotinib to compare how well they work when given alone or together as first-line therapy in treating older patients with stage IIIB or stage IV non-small cell lung cancer.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Bevacizumab and Erlotinib Followed by Cisplatin or Carboplatin and Gemcitabine in Treating Patients With Newly Diagnosed or Recurrent Stage IIIB or Stage IV NSCLC
NCT00354549
Combination Chemotherapy in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer
NCT00005972
Gemcitabine, Carboplatin or Paclitaxel Plus Radiation Therapy in Treating Patients With Stage IIIA or IIIB Non-Small Cell Lung Cancer
NCT00016315
A Study of Tarceva (Erlotinib) or Placebo in Combination With Platinum-Based Therapy as First Line Treatment in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
NCT00883779
Combination Chemotherapy, Bev, RT, and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer
NCT00280150
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Primary
* Compare the progression-free survival rate of older patients with stage IIIB or IV non-small cell lung cancer treated with gemcitabine hydrochloride vs erlotinib hydrochloride vs gemcitabine hydrochloride and erlotinib hydrochloride as first-line therapy.
Secondary
* Determine the response rate in patients receiving these regimens.
* Determine the overall survival rate in patients receiving these regimens.
* Determine the toxicity profile of these regimens in these patients.
* Determine the quality of life of patients receiving these regimens.
OUTLINE: This is a randomized, open-label, controlled, parallel group, multicenter study. Patients are stratified by gender, smoking status (never or light vs current or former), and ECOG performance status (0-1 vs 2). Patients are randomized to 1 of 3 treatment arms.
* Arm I: Patients receive gemcitabine hydrochloride IV on days 1 and 8. Patients with progressive disease may cross over to arm II.
* Arm II: Patients receive oral erlotinib hydrochloride daily on days 1-21.
* Arm III: Patients receive gemcitabine hydrochloride as in arm I and erlotinib hydrochloride as in arm II.
In all arms, treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 2 months for 3 years.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A
Patients receive gemcitabine hydrochloride 1200mg/m2 IV on days 1 and 8. Patients with progressive disease may cross over to arm B.
gemcitabine hydrochloride
given IV
Arm B
Patients receive oral erlotinib hydrochloride 150mg p.o. daily on days 1-21.
erlotinib hydrochloride
given orally
Arm C
Patients receive gemcitabine hydrochloride 1000mg/m2 IV on days 1 and 8 and erlotinib hydrochloride 100mg p.o. daily
erlotinib hydrochloride
given orally
gemcitabine hydrochloride
given IV
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
erlotinib hydrochloride
given orally
gemcitabine hydrochloride
given IV
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
70 Years
120 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Thomas E Stinchcombe, MD
Role: PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas, United States
Summit Cancer Care
Savannah, Georgia, United States
Evanston Hospital
Evanston, Illinois, United States
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
Batte Cancer Center at Northeast Medical Center
Concord, North Carolina, United States
Cape Fear Valley Medical Center Cancer Center
Fayetteville, North Carolina, United States
Rex Cancer Center at Rex Hospital
Raleigh, North Carolina, United States
Kingsport Hematology-Oncology Associates
Kingsport, Tennessee, United States
University of Tennessee Cancer Institute - Memphis
Memphis, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Clinical trial summary from the National Cancer Institute's PDQ® database
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UNC-LCCC-0512
Identifier Type: OTHER
Identifier Source: secondary_id
LCCC 0512
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.