GECO: Study of Rofecoxib and Prolonged Constant Infusion of Gemcitabine in the Polychemotherapy Treatment of Advanced Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute, Naples
• Treatments: Cisplatin; Gemcitabine; Rofecoxib

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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