A Phase 2/3 interventional study of gemcitabine and prolonged continuous infusion gemcitabine in Advanced Non-small Cell Lung Cancer, sponsored by National Cancer Institute, Naples. Completed at 25 sites in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-03-23.
Sponsored by National Cancer Institute, Naples · Phase 2/3, Interventional, and Treatment
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.
The primary end-points of the GECO study
Four treatment arms are planned.
The phase II part of the study for experimental arms B, C and D will be conducted to evaluate tolerability in the three treatment arms.
The phase III study for efficacy has been designed according to a factorial 2x2 model with the planned comparison of
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 400 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →National Cancer Institute, Naples is the lead sponsor of 112 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Gemcitabina 1200 mg/m2 infusion of 30 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks for 6 cycles.
Drug: gemcitabine · Drug: cisplatin
Gemcitabina 1200 mg/m2 infusion of 30 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks + rofecoxib 50 mg/die per os until progression of disease.
Drug: gemcitabine · Drug: cisplatin · Drug: rofecoxib
Gemcitabina 1200 mg/m2 infusion of 120 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks for 6 cycles.
Drug: prolonged continuous infusion gemcitabine · Drug: cisplatin
Gemcitabina 1200 mg/m2 infusion of 120 minutes at day 1, 8 + cisplatin 80 mg/m² day 1, every 3 weeks + rofecoxib 50 mg/die per os until progression of disease.
Drug: prolonged continuous infusion gemcitabine · Drug: cisplatin · Drug: rofecoxib
To evaluate the tolerability of three experimental treatment schedules
adverse events according to CTCAE criteria
Time frame: at the end of each cycle of chemotherapy (every 3 weeks) until 21 days after the last treatment administrationministration
To evaluate the efficacy of the addition of rofecoxib to first-line chemotherapy
response rate according to RECIST criteria
Time frame: at the end of cycle 3 and cycle 6 until the date of first documented PD (up to 1 year).
To evaluate the efficacy of prolonged continuous infusion (p.c.i.) of gemcitabine vs standard infusion, in combination with cisplatin
response rate according to RECIST criteria
Time frame: at the end of cycle 3 and cycle 6 until the date of first documented PD (up to 1 year).
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
National Cancer Institute, Naples