Advanced pancreatic adenocarcinoma - histologically/cytologically confirmed pancreatic adenocarcinoma which is not surgically resectable, in patients suitable for gemcitabine chemotherapy. MedDRA version: 9.1 Level: LLT Classification code 10033610 Term: Pancreatic carcinoma metastatic MedDRA version: 9.1 Level: LLT Classification code 10033611 Term: Pancreatic carci
Conditions
Interventions
Trade Name: Lipidem 200mg/ml
Product Name: Lipidem 200mg/ml
Product Code: n/a
Pharmaceutical Form: Emulsion for infusion
Sponsors
University Hospitals of Leicester NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with histologically or cytologically confirmed pancreatic adenocarcinoma, in whom the disease is assessed as unresectable, either due to metastatic or locally-advanced disease, and deemed suitable to receive gemcitabine chemotherapy will be eligible for the study. The inclusion criteria will be: Aged >18 years Able to give informed written consent ECOG performance status of 0 or 1 (Appendix 1) Life expectancy >12 weeks Adequate hepatic and renal function documented within 14 days prior to treatment AST and ALT =2.5x upper limit of normal (ULN), unless liver metastases present, in which case =5.0xULN Total bilirubin =1.0xULN Serum creatinine =1.5xULN or calculated creatinine clearance =60ml/min Urinary protein =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded from this trial if they have: Prior treatment with any systemic chemotherapy for metastatic disease Prior adjuvant radio- or chemotherapy within 4 weeks of starting the study Previous treatment with gemcitabine Hypersensitivity to fish-, egg-, or soy protein, or to any of the active substances or constituents in the lipid emulsion Any general contra-indications to infusion therapy – pulmonary oedema, hyperhydration, decompensated cardiac insufficiency Any unstable medical conditions – uncontrolled diabetes mellitus, acute myocardial infarction, stroke, embolic disease, metabolic acidosis, sepsis, pancreatitis Known HIV or AIDS Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with requirements of the protocol History of malignancy other than pancreatic cancer, with the exception of curative treatment for skin cancer (other than melanoma) or in situ breast or cervical carcinoma, or those treated with curative intent for any other cancer with no evidence of disease for 5 years Major surgical procedure or significant traumatic injury within 4 weeks of treatment Female patients must be surgically sterilised or postmenopausal or agree to use two adequate contraception measures during the period of therapy and continued for 6 months after the last dose of gemcitabine. Male patients must be surgically sterilised or agree to use adequate contraception for the same period. Patients deemed unsuitable for gemcitabine chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objective response rate (complete + partial response) of response of patients receiving gemcitabine plus parenteral omega-3.; Secondary Objective: Overall survival, progression free survival, and duration of response of patients receiving gemcitabine plus parenteral omega-3. Safety and tolerability of gemcitabine plus parenteral omega-3. Health-related quality of life, pain ratings, and health status of patients as measured by the European Organisation for the Research and Treatment of Cancer Quality of Life Questionairre Core 30 (EORTC QLQ-C30) questionaire, and Brief pain inventory short form (BPI-sf) Pharmacokinetic analysis by measuring omega-3/6 fatty acid levels and ratios in cellular membranes of blood leukocytes Changes in serum levels of markers, including Notch, Leukotrienes B5 and B4, TNF-? and IL-6 ;Primary end point(s): Study treatment will be administered in cycles of 4-week duration as per current gemcitabine chemotherapy protocol. Treatment will continue until progression of disease, unmanageable adverse events, or withdrawal of patient consent. The endpoint will be when all 50 patients have completed treatment, had a post-treatment follow up, and exited the study. | — |
Countries
United Kingdom
Outcome results
None listed