PHASE II TRIAL OF THE EFFECT OF GEMCITABINE WITH INTRAVENOUS OMEGA 3 FISH OIL INFUSION IN PATIENTS WITH UNRESECTABLE PANCREATIC ADENOCARCINOMA. - FISH OIL AND GEMCITABINE IN PANCREATIC ADENOCARCINOMA - VERSION 1

Phase 1

• Conditions: 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 carcinoma non-resectable; MedDRA version: 9.1 Level: PT Classification code 10033610 Term: Pancreatic carcinoma metastatic; MedDRA version: 9.1 Level: PT Classification code 10033611 Term: Pancreatic carcinoma non-resectable

• Registration Number: EUCTR2009-009470-27-GB
• Lead Sponsor: niversity Hospitals of Leicester NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-16
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 50

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 <1+ by urine dipstick. If =1+, then 24-hour urine collection should be done and may only be enrolled if urine protein is <2g/24hours
Adequate bone marrow function
Haemoglobin =9g/dL (can have transfusion or growth factors)
Platelets =100,000cells/mm3
Neutrophil count =1500cells/mm3
No significant hyperlipidaemia
Patients without severe blood coagulation disorders (anticoagulants allowed)
Women of childbearing age must have a negative pregnancy test (urine or serum) at commencement of treatment
Willingness to comply with scheduled visits, treatment, laboratory test, and other aspects of the trial

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified