Phase II study of combined 5-fluorouracil/Ginkgo biloba extract (GBE 761 ONC) therapy in 5-fluorouracil pretreated patients with advanced colorectal cancer

The aim of the study was to evaluate the efficacy, tolerability and quality of life in 5-fluorouracil (5-FU) pretreated colorectal cancer patients aft er combined 5-FU and Ginkgo biloba extract GEE 761 ONC (i.e. the Ginkgo bil oba special extract EGb 761(R)) therapy. Following conventional 5-FU therap y, 44 patients (32 evaluable for response) with advanced progressive colore ctal cancer were treated every 3 weeks with courses of 350 mg GEE 761 ONC a s a 30 min i.v. infusion on days 1-6 followed by 500 mg/m(2)/d 5-FU as a 30 min i.v. infusion on days 2-6, The response to therapy was evaluated after the second and fourth course of treatment. The data of 32 patients could b e evaluated for efficacy. We observed a progression of disease in 22 patien ts, no change in 8 patients and a partial response in 2 patients (overall r esponse = 6.3%). Seventeen of 22 patients with observed progressive disease showed further progression after two cycles, two after three cycles and th ree after four cycles. The median survival time was 9.5 months (7.7-11.5 mo nths). GBE 761 ONC was well tolerated. Adverse events that occurred during the study were mainly myelosuppression and gastrointestinal symptoms and we re judged to be 5-FU related or consistent with liver toxicity and thus tum our related, Our results suggest a good benefit-risk ratio of the combined 5-FU and GEE 761 ONC therapy as second Line treatment in metastatic colorec tal cancer, The survival time was similar to that known from second line tr eatment according to the Ardalan scheme. Since an improvement was observed in some patients despite the failure of the conventional 5-FU pretreatment, it would be interesting to evaluate whether the application of 5-FU plus G EE 761 ONC as a first line treatment is of benefit. Copyright (C) 2001 John Wiley & Sons, Ltd.