locally advanced or metastatic inoperable adenocarcinoma of the pancreas with no prior chemotherapy MedDRA version: 8.1 Level: LLT Classification code 10033606 Term: Pancreatic cancer non-resectable
Conditions
Interventions
Product Name: Lipoplatin
Product Code: Lipoplatin
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: cisplatin
CAS Number: 15663-27-1
Concentration unit: mg/ml milligram(s)/millilitre
Conc
Sponsors
Regulon ?.?.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adult male or female 18-70 years old. • Histologically or cytologically confirmed diagnosis of locally advanced or metastatic inoperable adenocarcinoma of the pancreas • Presence of at least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors. (RECIST, see Appendix II). • WHO performance status (PS) 0-1 (Appendix I). • Life expectancy of at least 3 months. • At least 4 weeks since prior major surgery, with full recovery from all side effects. • Adequate bone marrow function (defined as peripheral absolute granulocyte count > 2000/mm3 and platelet count = 140000/mm3). • Adequate liver function (bilirubin = 2 mg/dl, SGOT or SGPT no greater than 2.5 x ULN or 4 x ULN in case of hepatic metastasis). • Adequate renal function (creatinine = 1.5 mg/dl, creatinine clearance = 60ml/min). Clearance to be measured after 24-hour urine collection, or calculated by the following formulas: CrClmale=[(140-age)*(wt. as kg)]/[(serum Cr mg/dl)x72] CrClfemale=0.85*(CrClmale) • Patients must understand and sign an informed consent document that explains the neoplastic nature of his/her disease, the procedures to be followed, the experimental nature of the treatment, alternative treatments, and potential risks and toxicities. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Other malignancy within the past 5 years, except malignancies with 25% weight loss). • Recent history of myocardial infarction (within the last 6 months), history of congestive heart failure, congenital heart disease, or ventricular arrhythmias. • Known Hepatitis B or C, or AIDS. • Known underlying immune deficiency or history of autoimmune diseases (e.g. autoimmune neutropenia, hemolytic anaemia or thrombocytopenia, systemic lupus erythematosus, Sjögren syndrome, Addison’s disease, scleroderma, myasthenia Gravis, Goodpasture’s syndrome, Hashimoto’s thyroiditis or other diseases of autoimmune origin). • Pregnant or lactating women. For women of childbearing age an initial negative pregnancy test and usage of a reliable contraceptive method during and for 3 months after study participation is a requirement. • Any medical, psychiatric or social condition that would preclude informed consent (e.g. homeless patients or with dementia). • Patients for whom compliance with the protocol is doubtful.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: For Phase II • To assess the Disease Control Rate DCR (CR+PR+SD) For Phase III Primary endpoint: • To compare overall survival (OS) ;Secondary Objective: For Phase II • To assess the 1-year survival • To assess toxicity For Phase III • To compare progression-free survival time (PFS). • To compare objective response rate (ORR) • To compare quality of life (Q?L) • To compare safety ;Primary end point(s): Phase ??: • Disease Control Rate (DCR) is defined as the sum of Complete Response (CR) plus Partial Response (PR) plus Stable Disease (SD) at week 9 of treatment. Evaluation of response is based on the Response Evaluation Criteria in Solid Tumors (RECIST, see Appendix II), with confirmation at 4 weeks. DCR will be used instead of Objective Response Rate (ORR=Complete Response+Partial Response), as it is a more helpful measure in cancers difficult to evaluate or with only minor response to treatment, as is the case for pancreatic cancer. Although DCR at first post-baseline disease evaluation may be more sensitive to initial differences in tumor growth rate, most bibliographic references use the specific time, which was therefore chosen for the current study. Phase III: • Overall Survival (OS) is defined as the time from randomisation until death from any cause. | — |
Countries
Greece
Outcome results
None listed