| General information |
| Database: | DB00848 |
| Objective: | Gefitinib, an epidermal growth factor receptor tyrosine kinase inhibitor, has demonstrated a response rate of 9%18% in relapsed non small cell lung cancer (non small cell lung cancer) patients. The probability of response to gefitinib was not influenced by response to previous chemotherapy. Preclinical studies have suggested that celecoxib, a cyclooxygenase2 inhibitor, has antitumor activity in non small cell lung cancer and can enhance the activity of EGFR inhibitors. they conducted a phase II study evaluating the combination of gefitinib and celecoxib in platinumrefractory non small cell lung cancer patients, defined as patients whose disease had progressed on platinumbased chemotherapy or within 3 months of completing such therapy. |
| Authors: | Gadgeel SM, et al |
| Title: | Phase II study of gefitinib, an epidermal growth factor receptor tyrosine kinase inhibitor (EGFRTKI), and celecoxib, a cyclooxygenase2 (COX2) inhibitor, in patients with platinum refractory non small cell lung cancer (non small cell lung cancer). |
| Journal: | J Thorac Oncol. |
| Year: | 2007 |
| PMID: | 17409801 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | gefitinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Phase II study |
| Key Patients Feature: | Platinumrefractory non small cell lung cancer patients with performance status of 02 and adequate organ function were included. Patients should not have been on a NSAID for 30 continuous days before study enrollment. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients were treated with gefitinib 250 mg daily and celecoxib 400 mg twice daily. Disease assessment was performed every 8 weeks. |
| Primary End Point: | TTP, survival analysis and safety profile |
| Secondary End Point: | NA |
| Patients Number: | 27 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 7% |
| Disease Control Rate: | NA |
| Median Time to Progression: | 2.2 months |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | 4.6 months |
| Adverse Event(agent arm): | The combination was well tolerated and the adverse effects attributable to the drugs were very few. Cutaneous adverse effects were observed in seven patients, but none of these were more than grade 2. Diarrhea was observed in five patients, with only one patient developing grade 3 toxicity. Five patients were admitted with respiratory failure and clinical suspicion of pneumonitis. however, all patients had evidence of disease progression. One patient did have radiographic findings suggestive of pneumonitis but also had evidence of disease progression. None of the patients developed a cardiovascular event or episodes of venous thromboembolism. |
| Conclusions: | In unselected platinumrefractory non small cell lung cancer patients, the response rate to the combination of celecoxib and gefitinib was similar to that observed with gefitinib alone |