Unresectable oesophageal and/or gastric cancer
Conditions
Interventions
Trade Name: Omegaven
Product Name: Omegaven (omega-3 fish oil)
Pharmaceutical Form: Emulsion for infusion
INN or Proposed INN: Eicosapentaenoic acid (EPA)
CAS Number: 10417-94-4
Other descriptive name
Sponsors
University Hospitals of Leicester NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically confirmed gastric or oesophageal carcinoma (irrespective of subtype), deemed incurable as a result of standard staging investigations. • Measurable disease according to RECIST v1.1 criteria on CT within 4 weeks of study entry • WHO Performance status 0-2 • Aged >18 years • Able to give informed written consent • Life expectancy >12 weeks • Adequate hepatic and renal function documented within 7 days prior to treatment (estimated GFR>50ml/min, serum bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Prior radical treatment within 6 months of relapse • Prior treatment with any systemic chemotherapy for metastatic disease • Prior adjuvant radio- or chemotherapy within 4 weeks of starting the study • Patients with locally advanced disease deemed suitable for radical chemo-radiotherapy • Known hyperlipidaemic state (use of a statin permissible) • Patients with known coagulation disorders • Hypersensitivity to fish, egg 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 hepatitis B or C carrier • 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 gastric or oesophageal 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 • Cerebral metastases • History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan • Known peripheral neuropathy > Grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible). • Lack of physical integrity of the upper gastro-intestinal tract, malabsorption syndrome, or inability to take oral medication (administration of capecitabine by naso-gastric or jejunostomy feeding tube is permitted).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To see whether adding intravenous ?-3 FA emulsion to standard palliative chemotherapy (EOX) improves quality of life and/or prognosis, in patients with incurable gastric or oesophageal carcinoma.;Secondary Objective: • To determine the toxicity profile of the combination of omega-3 fish oil with standard EOX chemotherapy • To determine complete and partial response rates (as per RECIST v1.1 criteria) • To determine the feasibility of use of omega-3 fish oil with standard EOX chemotherapy • To collect tumour and blood samples for future translational work including investigating cytokine levels (leukotrienes B4, B5), Tumour necrosis factor-alpha, Interleukein-1, Iterleukein-2 and Interleukein-6; determining ?-3/6 ratios in cellular membranes of blood leucocytes, erythrocytes, plasma, platelets and tumour tissue • To determine quality of life, pain ratings and health status of patients using the EORTC QLQ-C30 questionnaire, brief pain inventory short form and dysphagia scores respectively • To determine the cost-effectiveness of the treatment by means of determination of NHS costs and quality of life using the EQ-5D questionnaire, enabling QALYs to be calculated;Primary end point(s): To determine the anti-tumour activity of the combination of omega-3 fish oil in combination with standard palliative EOX chemotherapy as measured by PFS. This is the time from enrolment to any disease progression and/or death, defined according to strict radiological criteria (Response Evaluation Criteria in Solid Tumours (RECIST v 1.1). Lesions will be compared to baseline measurements to assess progression.;Timepoint(s) of evaluation of this end point: The primary end point will be at 36 weeks from the commencement of the palliative treatment, each participant will have a CT scan at this time to evaluate for any progression, which will be used to assess for the progression free survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Evaluation of toxicity, feasability and effect of fish oil infusion. • Overall survival (OS).;Timepoint(s) of evaluation of this end point: •A safety review of toxicities will be performed after 10 and 21 patients have completed at least one cycle of chemotherapy and omega-3 fish oil treatment, If the review concludes that there is excess unacceptable toxicity then the safety committee may recommend that recruitment into the trial should cease. If the committee deem the trial safe to continue, recruitment will continue until a further 24 participants have been recruited (i.e. a total of 45 participants). •Time from enrolment to death for the overall survival. | — |
Countries
United Kingdom
Contacts
Public ContactMr Amar Eltweri
Niversity hospitals of Leicester
Outcome results
None listed