NCT01401166.

PECAM-1 is an adhesion molecule that plays an important role in the process of tumour disease dissemination since a function in transendothelial migration, angiogenesis and immune response has been shown for this membrane protein. Nevertheless the expression of PECAM-1 protein in solid tumours is a controversial matter and it has not been clarified so far. Thus, the aim of our study was to investigate PECAM-1 expression by immunohistochemistry in primary carci-nomas from colon, breast, bladder, ovary and kidney, and in their metastases. In addition an example of primary and metastatic melanoma was also investigated. We found that PECAM-1 is expressed in the metastases of all primary car-cinomas that express PECAM-1 (colorectal, breast and urothelial bladder). By the contrary metastases from primary carcinomas non-expressing PECAM-1 are also negative for expression. In conclusion, our findings support a possible role of this molecule in metastatic development of a subset of malignant human epithelial tumours.

A phase II study was conducted to evaluate the safety and efficacy of the combination GIP (gemcitabine, ifosfamide, and cisplatin) for the treatment of patients with advanced non-small-cell lung cancer (NSCLC). Thirty patients with stage III B/IV NSCLC were treated with a combination of GIP. Patients received gemcitabine 1,000 mg/m2 administered intravenously on days 1 and 8, ifosfamide 3,500 mg/m2 on day 2, and cisplatin 80 mg/m2 on day 2, repeated every 21 days. Two of the 30 patients (7%) showed a complete response and 14 patients (46%) showed a partial response. The overall response rate was 53%. The estimated median survival for all patients was 60 weeks. All patients enrolled onto the study were eligible for toxicity assessment. Toxicities were treatable and included World Health Organization grade III or IV leukopenia (29%), thrombocytopenia (18%), anemia (7%) and nausea, and vomiting (6%). Febrile neutropenia occurred in 3 of 30 patients. There were no treatment-related deaths. The combination therapy of GIP is active, well tolerated, and easy to administer on an outpatient basis in advanced NSCLC.

A phase II study was conducted to evaluate the safety and efficacy of the combination GIP (gemcitabine, ifosfamide, and cisplatin) for the treatment of patients with advanced non-small-cell lung cancer (NSCLC). Thirty patients with stage III B/IV NSCLC were treated with a combination of GIP. Patients received gemcitabine 1,000 mg/m2 administered intravenously on days 1 and 8, ifosfamide 3,500 mg/m2 on day 2, and cisplatin 80 mg/m2 on day 2, repeated every 21 days. Two of the 30 patients (7%) showed a complete response and 14 patients (46%) showed a partial response. The overall response rate was 53%. The estimated median survival for all patients was 60 weeks. All patients enrolled onto the study were eligible for toxicity assessment. Toxicities were treatable and included World Health Organization grade III or IV leukopenia (29%), thrombocytopenia (18%), anemia (7%) and nausea, and vomiting (6%). Febrile neutropenia occurred in 3 of 30 patients. There were no treatment-related deaths. The combination therapy of GIP is active, well tolerated, and easy to administer on an outpatient basis in advanced NSCLC.