Status:
COMPLETED
Study of Rofecoxib and Prolonged Constant Infusion of Gemcitabine in the Polychemotherapy Treatment of Advanced NSCLC
Lead Sponsor:
National Cancer Institute, Naples
Conditions:
Advanced Non-small Cell Lung Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief 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 gemcita...
Detailed Description
The primary end-points of the GECO study * To evaluate the tolerability of three innovative schedules of treatment for advanced NSCLC * To evaluate the efficacy of the addition of rofecoxib to first-...
Eligibility Criteria
Inclusion
- Cytologic or histologic diagnosis of non-small cell lung cancer
- Disease stage IIIB or IV
- Age less than 70 years
- ECOG performance status 2 or less
- Patients with cerebral metastases are permitted if they are asymptomatic and do not require radiation therapy concomitant with chemotherapy
- Negative history of allergy to non-steroidal anti-inflammatory and/or sulphonamide drugs
- Patients previously treated with radiation therapy are permitted if at least 4 weeks have passed since last therapy
- Written informed consent
Exclusion
- Previous chemotherapy
- Previous or concomitant malignant neoplasm (excluding adequately treated baso or spinocellular skin carcinoma or carcinoma in situ of the cervix)
- Neutrophil \< 2000/mm3, platelets \< 100,000/mm3, haemoglobin \< 10 g/dl
- Creatinine \> 1.25 x the upper normal limits
- GOT and/or GPT and/or Bilirubin \> 1.25 the upper normal limits in absence of hepatic metastases
- GOT and/or GPT and/or Bilirubin \> 2.5 the upper normal limits in presence of hepatic metastases
- Any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study
- Inability to comply with follow-up
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00385606
Start Date
January 1 2003
End Date
July 1 2006
Last Update
March 23 2023
Active Locations (25)
Enter a location and click search to find clinical trials sorted by distance.
1
Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
Monteforte Irpino, AV, Italy, 83024
2
Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica
Acquaviva delle Fonti, BA, Italy, 70021
3
IRCCS Oncologico Bari, Oncologia Medica
Bari, BA, Italy, 70126
4
Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale
Bari, BA, Italy, 70126