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.(ABSTRACT TRUNCATED AT 250 WORDS)