An anti-cancer agent containing benzene-poly-carboxylic acids complex with cis-diammineplatinum (II)
dichloride (BP-C1) was developed to establish a low toxic and cost effective treatment of breast cancer. The study was
aimed to investigate if BP-C1 could be given continuously without rest periods and to estimate Maximum Tolerated
(MTD) and Minimum Efficient Dose (MED) in metastatic breast cancer (MBC) treatment. A non-randomized, multicentre
trial with 3-level Response Surface Pathway design was performed. Five MBC patients were included at each of
the three design levels. BP-C1 was daily administrated intramuscularly during 32 days. The first five patients were given a
cumulative dose of 0.64 mg/kg bodyweight. Based on the obtained results, the dose was increased /decreased for the next
five patients in the next design level. The main variable was the National Cancer Institute Common Toxicity Criteria
(NCI-CTC). Cumulative doses of 0.96 mg/kg or higher were defined as high-dose. One moderate and one mild increase in
maximum NCI-CTC were found on 0.64 mg/kg, one mild increase occurred on 0.96 mg/kg and no changes were detected
on 1.12 mg/kg. The Sum NCI-CTC increased (p=0.07) in the low-dose group, but reduced (p=0.09) in the high-dose
group. In the high-dose group, 62.5% of the patients were classified as responders including one complete responder
compared to 28.6% in the low-dose group. In conclusion, BP-C1 can safely be administrated continuously during 32 days.
The MTD is larger than 1.12 mg/kg and MED estimated to 0.96 mg/kg.