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Phase II Trial of the Effect of Gemcitabine With Intravenous Omega-3 Fish Oil Infusion in Patients With Unresectable Pancreatic Adenocarcinoma

Phase 2
18 Years
Open (Enrolling)
Pancreatic Neoplasms

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Trial Information

Phase II Trial of the Effect of Gemcitabine With Intravenous Omega-3 Fish Oil Infusion in Patients With Unresectable Pancreatic Adenocarcinoma

Our trial will involve recruiting patients who have unresectable pancreatic cancer and who
are suitable for the current standard of care which is gemcitabine chemotherapy. They will
be assessed for suitability and then offered entry into the trial. This essentially
consists of a 4 hour long infusion of purified omega-3 fish oil immediately after their
gemcitabine chemotherapy has finished. This will occur once a week for three weeks, with a
rest on the fourth week. The cycle then continues until the cancer has shown progression on
a CT scan, the gemcitabine chemotherapy is stopped due to toxicity or the patient withdraws
or dies. CT scans to assess this are performed every 2 months. Blood tests will be taken
before and after each treatment and analysed for changes in inflammatory markers. The
patients will be asked to fill in a quality of life and pain questionnaire each week during
the 4 hour infusion.

Inclusion Criteria:

- 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 ≤2.5xULN 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

- 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

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (complete and partial response) on CT according to RECIST criteria

Outcome Time Frame:

Every 2 months

Safety Issue:


Principal Investigator

Ashley Dennison, MD FRCS

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospitals, Leicester


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

October 2009

Completion Date:

June 2014

Related Keywords:

  • Pancreatic Neoplasms
  • pancreatic
  • carcinoma
  • cancer
  • fish
  • alternative
  • Neoplasms
  • Pancreatic Neoplasms