A Study of the Effect of Gemcitabine With Fish Oil in Patients With Advanced Pancreatic Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
B. Braun Medical Inc.
Information provided by (Responsible Party):
University Hospitals, Leicester
ClinicalTrials.gov Identifier:
NCT01019382
First received: October 27, 2009
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

Over 7000 patients are diagnosed with pancreas cancer every year in the UK. Only 10% have it caught early enough to have surgery to cure it. The rest at best can undergo chemotherapy to extend survival, but current treatments offer at best an improvement of only a few months compared to no treatment at all. In addition only about a quarter of patients will respond to the treatment. In addition these patients often experience profound weight loss, loss of appetite and energy primarily because of the cancer process itself. Our hypothesis is that the addition of fish oil infusion to gemcitabine chemotherapy will result in an improved rate of tumour response on CT imaging.

Fish oils, or specifically the omega-3 fatty acid component, appear to have a range of powerful anti-cancer actions. This is supported by evidence from a wide range of sources, from laboratory experiments to basic human studies. Although this evidence specifically includes many pancreatic cancer studies in the laboratory it has not yet been confirmed in human trials.

Contrary to conventional chemotherapy, fish oil is a naturally occuring non-toxic compound and so is not associated with the side-effects of chemotherapy. In fact a number of clinical studies have demonstrated significant improvements in quality of life for pancreas cancer patients treated with fish oil, particularly with reference to improvements in appetite and energy levels. This is of course in addition to the anti-cancer actions.


Condition Intervention Phase
Pancreatic Neoplasms
Drug: Lipidem fish oil infusion + Gemcitabine chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of the Effect of Gemcitabine With Intravenous Omega-3 Fish Oil Infusion in Patients With Unresectable Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by University Hospitals, Leicester:

Primary Outcome Measures:
  • Objective response rate (complete and partial response) on CT according to RECIST criteria [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: measured once for each patient ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: Measured once for each patient ] [ Designated as safety issue: No ]
  • Safety / tolerability of fish oil and gemcitabine [ Time Frame: weekly ] [ Designated as safety issue: Yes ]
  • Quality of life scores [ Time Frame: weekly ] [ Designated as safety issue: No ]
  • brief pain inventory scores [ Time Frame: weekly ] [ Designated as safety issue: No ]
  • Pharmacokinetic analysis of blood samples [ Time Frame: weekly (before and after treatment) ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All patients
All patients entering the trial
Drug: Lipidem fish oil infusion + Gemcitabine chemotherapy
500mls intravenous infusion once a week of lipidem in addition to standard starting dose of gemcitabine (1000mg/m2) Dose can be reduced if poorly tolerated
Other Name: Gemzar

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 <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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01019382

Locations
United Kingdom
University Hospitals of Leicester : Leicester Royal Infirmary
Leicester, Leicestershire, United Kingdom, LE1 5WW
Sponsors and Collaborators
University Hospitals, Leicester
B. Braun Medical Inc.
Investigators
Principal Investigator: Ashley Dennison, MD FRCS University Hospitals, Leicester
Study Director: William Steward, Phd FRCP University Hospitals, Leicester
Study Chair: Matthew Metcalfe, MA MD FRCS University Hospitals, Leicester
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospitals, Leicester
ClinicalTrials.gov Identifier: NCT01019382     History of Changes
Other Study ID Numbers: 09/H0408/51, EudraCT number 2009-009470027, UHL trial number 10720
Study First Received: October 27, 2009
Last Updated: June 24, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University Hospitals, Leicester:
pancreatic
carcinoma
cancer
fish
alternative

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 30, 2014