Benzene-poly-carboxylic acids complex with cis-diammineplatinum (II) dichloride in the treatment of stage IV breast cancer patients
Journal
Open Breast Cancer Journal
Journal Volume
5
Journal Issue
1
Pages
7��15��
Date Issued
2013
Author(s)
Abstract
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. ? Dewi et al.; Licensee Bentham Open.
Subjects
Benzene-poly-carboxylic acids complex with cis-diammineplatinum (II) dichloride; Dose-response; MBC and phase I study; Response surface pathway design
SDGs
Other Subjects
alanine aminotransferase; antineoplastic agent; benzene poly carboxylic acid complex plus cisplatin; bilirubin; bp c1; C reactive protein; gamma glutamyltransferase; lactate dehydrogenase; nitrogen; unclassified drug; urea; adult; aged; alanine aminotransferase blood level; albumin blood level; article; bilirubin blood level; bone metastasis; breast cancer; cancer patient; cancer staging; clinical article; disease severity; dose response; drug dose comparison; drug dose escalation; drug dose increase; drug dose reduction; drug efficacy; drug megadose; drug safety; female; gamma glutamyl transferase blood level; human; Karnofsky Performance Status; lactate dehydrogenase blood level; liver metastasis; low drug dose; lung metastasis; maximum efficient dose; maximum tolerated dose; multicenter study; open study; outcome assessment; pharmacological parameters; priority journal; side effect; thrombocytopenia; treatment duration; treatment response; unspecified side effect; urea nitrogen blood level
Type
journal article