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Esophageal NeoplasmPhase 2NCT01870791

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

A Phase 2 study testing Omegaven in people with Esophageal Neoplasm and Gastric Neoplasm, run by University Hospitals, Leicester at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Neoplasm, Gastric Neoplasm
What is being tested?
Omegaven
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited Kingdom
Study dates
May 2012to Dec 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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).

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • University Hospitals of Leicester NHS Trust

    Leicester, Leicestershire, LE1 5WW

Other trials in United Kingdom

About this study

Official title: 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.

Being tested
Omegaven
Keywords
Esophageal adenocarcinoma, Gastric adenocarcinoma
Medical subject headings
Esophageal Neoplasms, Stomach Neoplasms, Adenocarcinoma Of Esophagus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OmegavenDrug

    Also called Omega-3 fish oil

    Weekly omegaven infusion in combination with EOX chemotherapy

Study groups in NCT01870791
Study groupRoleWhat they receive
OmegavenExperimentalOmegaven in combination with EOX chemotherapy
Receives: Drug: Omegaven

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival

    Progression free survival from enrolment to disease progression

    Measured: 12 months

Secondary outcomes (5)

  1. Safety profile

    The number of participants requiring dose delays

    Measured: 12 months

  2. Efficacy

    Objective response rate as assessed by RECIST v1.1

    Measured: 6 and 12 months

  3. Safety profile

    The number of participants experiencing adverse effects

    Measured: 12 months

  4. Safety profile

    The number of participants requiring dose modifications

    Measured: 12 months

  5. Safety profile

    The number of participants requiring treatment withdrawal due to adverse effects

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2013 (estimated)
  2. Study startMay 2012
  3. Primary completionDec 2015
  4. Study completionDec 2015

Why it stopped: Interim analysis

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01870791
Sponsor's protocol ID
11122
Other IDs
2011-003950-24
Status last verified
May 2016
First submitted
28 May 2013
Last updated
26 May 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Eltweri AM, Thomas AL, Fisk HL, Arshad A, Calder PC, Dennison AR, Bowrey DJ. Plasma and erythrocyte uptake of omega-3 fatty acids from an intravenous fish oil based lipid emulsion in patients with advanced oesophagogastric cancer. Clin Nutr. 2017 Jun;36(3):768-774. doi: 10.1016/j.clnu.2016.06.001. Epub 2016 Jun 7.

    PubMed 27342748

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Omegaven in people with Esophageal Neoplasm and Gastric Neoplasm, run by University Hospitals, Leicester at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Interim analysis). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01870791, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2016.

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