Spots Global Cancer Trial Database for Ph II Gemcitabine, Erlotinib, and Gemcitabine With Erlotinib/Elderly Patients W/ IIIB/IV NSCLC
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Trial Identification
Brief Title: Ph II Gemcitabine, Erlotinib, and Gemcitabine With Erlotinib/Elderly Patients W/ IIIB/IV NSCLC
Official Title: Randomized Phase II Study of First-Line Treatment With Gemcitabine vs. Erlotinib vs. Gemcitabine and Erlotinib in Elderly Patients With Stage IIIB/IV Non-Small Cell Lung Cancer
Study ID: NCT00283244
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether gemcitabine and erlotinib are more effective when given alone or together in treating non-small cell lung cancer. 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.
Detailed Description: OBJECTIVES: 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.
Eligibility
Minimum Age: 70 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Thomas E Stinchcombe, MD
Affiliation: UNC Lineberger Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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