bp-c1 in short-term treatment of metastatic pancreatic cancer

Conditions: Metastatic Pancreatic Cancer; Unresectable Pancreatic Cancer

Summary: the aim of this study is to investigate the short-term effect and tolerability bp-c1 in patients with metastatic pancreatic cancer who has undergone guideline-recommended chemotherapy.

bp-c1, solution for injections 0.05%, is currently being developed for treatment of patients with metastatic breast cancer and metastatic pancreatic cancer with palliative intent. active substance of the product, which is a novel platinum-containing anticancer agent developed for intramuscular administration, is a complex between cis-diammineplatinum(ii) derived core and an amphiphilic polymer, containing a composition of benzene polycarboxylic acids. the amphiphilic characteristics of the polymer have resulted in a product with clear and significantly altered and improved properties compared to other platinum analogues, e.g. cisplatin, carboplatin and oxaliplatin. bp-c1 preserves antitumour activity of its predecessors (e.g. cisplatin and carboplatin), additionally offering the following advantages that ensure favourable outcome of treatment in metastatic cancer patients: * injectable solution (intramuscular) does not cause injection site reactions; * can be administered at home by a nurse or a patient; * has an improved pharmacokinetic profile; * exerts an additional immunomodulatory activity. bp-c2 is a novel lignin-derived polyphenolic composition with ammonium molybdate. bp-c2, given orally, is believed to reduce the toxicity of chemotherapeutic agents. this is a single center, two arm, open label pilot study (phase iia). the eligible patients will be allocated either to bp-c1 arm or to bp-c1+bp-c2 arm and treated for 32 days with further follow-up for 28 days.

Eligibility criteria:
inclusion criteria: * patients of all genders between 18 and 80 years of age with metastatic pancreatic cancer (unresectable pancreatic cancer with increased levels of cancer antigen 19-9), who had an expected survival time of at least 3 months. exclusion criteria: patients fulfilling at least one of the following criteria will be excluded from participation in the study: * abnormal liver function classified as total bilirubin \>136 μmol/l (8.0 mg/dl) * abnormal kidney function defined by serum creatinine \>120 μmol/l (1.5 mg/dl). * abnormal coagulation capacity defined by the relative arbitrary concentration of coagulation factors 2,7,10 \ 1.5. * verified metastases to the brain. * synchronous cancer except for non-melanoma skin cancer and early stage of cervical cancer. * abnormal haematology status defined by hemoglobin \< 6.0 g/dl, platelet count \< 100,000/mm\^3 or leucocytes \< 3 x 10\^9/l. * clinically significant abnormal ecg. * karnofsky performance status score \<60%. * pregnancy or breast-feeding. * women of fertile age who do not want to be tested for possible pregnancy. * uncontrolled bacterial, viral, fungal or parasite infection. * under systemic treatment with corticosteroids or other immunosuppressive drugs in the last 21 days before start of the trial treatment. * participating in another clinical trial with pharmaceuticals in the last six weeks before start of this trial treatment. * not able to understand information. * not willing or not able to give written consent to participate in the study.

Keywords: benzene polycarboxylic acids complex with cis-diammineplatinum(ii) bp-c1 cis-coordinated complexes of platinum(ii) with polymer of benzene polycarboxylic acids derived from lignin platinum analogue metronomic chemotherapy cisplatin pancreatic cancer bp-c2 molybdenum salts of benzene-polycarboxylic acids