caa a22 4500 465789854 CHVBK 20180323112020.0 cr unu---uuuuu 170327e19900301xx s 000 0 eng 10.1007/BF00171993 doi (NATIONALLICENCE)springer-10.1007/BF00171993 Phase II trials with flavone acetic acid (NCS. 347512, LM975) in patients with advanced carcinoma of the breast, colon, head and neck and melanoma [Elektronische Daten] [S. Kaye, M. Clavel, P. Dodion, S. Monfardini, W. ten Bokkel-Huinink, D. Wagener, S. Gundersen, G. Stoter, J. Smith, J. Renard, M. van Glabbeke, F. Cavalli] Summary: Phase II trials of flavone acetic acid have been performed in a total of 87 patients including 17 with advanced breast cancer, 23 with advanced colorectal cancer, 25 with advanced malignant melanoma and 22 with advanced head and neck cancer. Patients with colorectal cancer and melanoma had received no prior chemotherapy; in breast and head and neck cancer patients prior chemotherapy had been given with a median of 5 and 2 drugs respectively. The schedule used was a once-weekly regime, with a dose of 4.8 gms/m2 given as a 1 hour infusion, together with alkalinization (with i.v. sodium bicarbonate) given before and after FAA. Reassessment was performed after 6 weekly doses, although in 23 patients fewer than 6 doses were given, because of early disease progression in 15, and undue toxicity in 5. An additional 3 patients died within 72 hours of having received FAA and, although the precise cause of death in each case was not established, FAA toxicity could not be excluded. Treatment was generally manageable, the major manifestations of toxicity comprising uncomfortable warmth and flushes, nausea, diarrhoea, and visual complaints. Hypotension was also documented in 8 patients. No objective responses were seen in any of the patient sub-groups, although disease-stabilization was seen in 3 patients with breast cancer, 1 patient with advanced colorectal cancer, 2 patients with advanced melanoma and 4 patients with head and neck cancer. Further Phase II studies, using a higher dose of 8.6 gm/m2 over 6 hours once weekly, are currently in progress in Europe. However, Phase II studies to date indicate no antitumor activity of FAA given weekly as a single agent at the maximally tolerated dose over 1 hour. Kluwer Academic Publishers, 1990 phase II trial nationallicence flavone acetic acid nationallicence advanced carcinoma nationallicence Kaye S. Beatson Oncology Centre, Western Infirmary, Glasgow, Scotland aut Clavel M. Centre Leon-Berard, Lyon, France aut Dodion P. Institut Jules Bordet, Brussels, Belgium aut Monfardini S. Centro di Riferimento Oncologico, Aviano, Italy aut ten Bokkel-Huinink W. Netherlands Cancer Institute, Amsterdam, The Netherlands aut Wagener D. University Hospital, Nijmegen, The Netherlands aut Gundersen S. Norwegian Radium Hospital, Oslo, Norway aut Stoter G. Rotterdam Cancer Institute, The Netherlands aut Smith J. Western General Hospital, Edinburgh, Scotland aut Renard J. E.O.R.T.C. Data Centre, Brussels, Belgium aut van Glabbeke M. E.O.R.T.C. Data Centre, Brussels, Belgium aut Cavalli F. Ospedale San Giovanni, Bellinzona, Italy aut Investigational New Drugs Kluwer Academic Publishers 8(1990-03-01), S95-S99 0167-6997 8<S95 1990 8 10637 https://doi.org/10.1007/BF00171993 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/BF00171993 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Kaye S. Beatson Oncology Centre, Western Infirmary, Glasgow, Scotland aut NATIONALLICENCE 700 1- Clavel M. Centre Leon-Berard, Lyon, France aut NATIONALLICENCE 700 1- Dodion P. Institut Jules Bordet, Brussels, Belgium aut NATIONALLICENCE 700 1- Monfardini S. Centro di Riferimento Oncologico, Aviano, Italy aut NATIONALLICENCE 700 1- ten Bokkel-Huinink W. Netherlands Cancer Institute, Amsterdam, The Netherlands aut NATIONALLICENCE 700 1- Wagener D. University Hospital, Nijmegen, The Netherlands aut NATIONALLICENCE 700 1- Gundersen S. Norwegian Radium Hospital, Oslo, Norway aut NATIONALLICENCE 700 1- Stoter G. Rotterdam Cancer Institute, The Netherlands aut NATIONALLICENCE 700 1- Smith J. Western General Hospital, Edinburgh, Scotland aut NATIONALLICENCE 700 1- Renard J. E.O.R.T.C. Data Centre, Brussels, Belgium aut NATIONALLICENCE 700 1- van Glabbeke M. E.O.R.T.C. Data Centre, Brussels, Belgium aut NATIONALLICENCE 700 1- Cavalli F. Ospedale San Giovanni, Bellinzona, Italy aut NATIONALLICENCE 773 0- Investigational New Drugs Kluwer Academic Publishers 8(1990-03-01), S95-S99 0167-6997 8<S95 1990 8 10637 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer