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

Phase 2
18 Years
Open (Enrolling)
Esophageal Neoplasm, Gastric Neoplasm

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Trial Information

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

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

- WHO 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 GFR>50ml/min, serum bilirubin < 1.5x ULN; ALT or AST < 2.5x ULN; ALP < 3x
ULN (in the absence of liver metastases). If liver metastases are present, serum
transaminases < 5x ULN 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).

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

Progression free survival from enrolment to disease progression

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

David J Bowrey, MD

Investigator Role:

Study Director

Investigator Affiliation:

University Hospitals, Leicester


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

May 2012

Completion Date:

November 2014

Related Keywords:

  • Esophageal Neoplasm
  • Gastric Neoplasm
  • Esophageal adenocarcinoma
  • Gastric adenocarcinoma
  • Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms