Study of Rofecoxib and Prolonged Constant Infusion of Gemcitabine in the Polychemotherapy Treatment of Advanced NSCLC
NCT00385606 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2023-03-23
Summary
The purpose of this study is to evaluate the tolerability and efficacy of the addition of rofecoxib to first-line chemotherapy, and to evaluate the efficacy of prolonged continuous infusion of gemcitabine in combination with cisplatin in the treatment of patients affected by advanced non-small cell lung cancer.
Conditions
Interventions
- DRUG
- DRUG
-
prolonged continuous infusion gemcitabine
- DRUG
- DRUG
-
rofecoxib
Sponsors & Collaborators
-
National Cancer Institute, Naples
lead OTHER
Principal Investigators
-
Cesare Gridelli, M.D. · San Giuseppe Moscati Hospital, Avellino, Italy
-
Francesco Perrone, M.D., Ph.D. · National Cancer Institute Naples, Italy
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-01-31
- Primary Completion
- 2005-12-31
- Completion
- 2006-07-31
Countries
- Italy
Study Locations
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