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

Gastric Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01870791
• Other study ID #: 11122
• Secondary ID: 2011-003950-24
• Status: Terminated
• Phase: Phase 2
• First received: May 28, 2013
• Last updated: May 25, 2016
• Start date: May 2012
• Est. completion date: December 2015

Study information

• Verified date: May 2016
• Source: University Hospitals, Leicester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Esophageal Neoplasm
• Esophageal Neoplasms
• Gastric Neoplasm
• Neoplasms
• Stomach Neoplasms

Intervention

Drug:
• Omegaven
Weekly omegaven infusion in combination with EOX chemotherapy

Locations

Country	Name	City	State
United Kingdom	University Hospitals of Leicester NHS Trust	Leicester	Leicestershire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals, Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Progression free survival from enrolment to disease progression	12 months	No
Secondary	Safety profile	The number of participants requiring dose delays	12 months	Yes
Secondary	Efficacy	Objective response rate as assessed by RECIST v1.1	6 and 12 months	No
Secondary	Safety profile	The number of participants experiencing adverse effects	12 months	Yes
Secondary	Safety profile	The number of participants requiring dose modifications	12 months	Yes
Secondary	Safety profile	The number of participants requiring treatment withdrawal due to adverse effects	12 months	Yes

External Links

•   European Clinical Trials Register