Study of Additive Omega-3 Fish Oil to Palliative Chemotherapy to Treat Oesophagogastric Cancer

May 25, 2016 updated by: University Hospitals, Leicester

Phase II Trial of Palliative Epirubicin, Oxaliplatin & Capecitabine (EOX) Chemotherapy Combined With Omega-3 Fish Oil Infusion (Omegaven) in Patients With Oesophagogastric Carcinoma

The prognosis for patients with advanced oesophago-gastric cancer is poor. Approximately 16,000 patients in the United Kingdom die from the disease. In spite of new chemotherapy regimens, the average survival for these patients is around 9 months from diagnosis.

Omegaven is an infusion comprising omega-3 fish oils. There is evidence that omega-3 fish oil supplementation can improve general well-being and quality of life in patients receiving palliative chemotherapy for a number of different cancer types. It has also been suggested that omega-3 fish oil supplementation may reduce the toxicity of chemotherapy.

This clinical trial aims to see whether the addition of Omegaven to EOX chemotherapy, the most widely used regimen for patients with advanced oesophago-gastric cancer, will make this drug regimen more effective at killing oesophago-gastric cancer cells, such that disease progression is delayed. Forty-five patients who have been diagnosed with advanced oesophago-gastric cancer will be recruited over a two year period to receive standard chemotherapy and omega-3 fish oil supplementation. The results in these 45 patients will be compared to a matched historical control group of patients who have received identical chemotherapy. If results suggest that the combination of EOX and Omegaven is sufficiently effective, tolerable and feasible then it will be the intention of the trial team to take the combination forward to treat patients with advanced oesophago-gastric cancer in a randomised study.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE1 5WW
        • University Hospitals of Leicester NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • World Health Organization 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 glomerular filtration rate>50ml/min, serum bilirubin < 1.5x upper limit of normal; Alanine transaminase or aspartate transaminase < 2.5x upper limit of normal; Alkaline phosphatase< 3x upper limit of normal (in the absence of liver metastases). If liver metastases are present, serum transaminases < 5x upper limit of normal are permitted.)
  • Adequate bone marrow function documented within 7 days (haemoglobin ≥9g/dL, platelets ≥100,000cells/mm3, neutrophil count ≥1500cells/mm3)
  • Women of childbearing age must have a negative pregnancy test (urine or serum) at commencement of treatment
  • Willing to use contraception if applicable
  • Willingness to comply with scheduled visits, treatment, laboratory test, and other aspects of the trial

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
  • Hypersensitivity to fish- or egg protein or to any of the active substances or constituents in the lipid emulsion
  • Patients with known coagulation disorders
  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omegaven
Omegaven in combination with EOX chemotherapy
Drug: Omegaven
Weekly omegaven infusion in combination with EOX chemotherapy
Other Names:
  • Omega-3 fish oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 12 months
Progression free survival from enrolment to disease progression
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety profile
Time Frame: 12 months
The number of participants requiring dose delays
12 months
Efficacy
Time Frame: 6 and 12 months
Objective response rate as assessed by RECIST v1.1
6 and 12 months
Safety profile
Time Frame: 12 months
The number of participants experiencing adverse effects
12 months
Safety profile
Time Frame: 12 months
The number of participants requiring dose modifications
12 months
Safety profile
Time Frame: 12 months
The number of participants requiring treatment withdrawal due to adverse effects
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals, Leicester

Investigators

  • Study Director: DAVID J BOWREY, MD, University Hospitals, Leicester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

May 28, 2013

First Submitted That Met QC Criteria

June 3, 2013

First Posted (Estimate)

June 6, 2013

Study Record Updates

Last Update Posted (Estimate)

May 26, 2016

Last Update Submitted That Met QC Criteria

May 25, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11122
  • 2011-003950-24 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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