Tamoxifen in Patients With Oesophageal Cancer

• Status: Unknown status
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Cancer of the gullet (oesophagus) is a lethal disease in which only 15% of patients survive 5 years once diagnosed. It is more common in men than women, and men appear to have a worse prognosis. One suggestion for this gender difference is the sex hormone oestrogen, which exerts its effect via oestrogen receptors. The role of oestrogen in breast cancer is well described, and antioestrogen medication such as tamoxifen, which blocks oestrogen receptors are in widespread and effective use. The role of oestrogen receptors in oesophageal cancer however, is less well defined. Work conducted by the investigators, as well as another research group in Australia showed that antioestrogens including tamoxifen, reduce oesophageal cancer cell growth in the laboratory. To date, no studies have assessed the effect of tamoxifen therapy on oesophageal cancer growth in humans. The investigators propose a study to determine the effect of tamoxifen in patients with oesophageal cancer who aren't undergoing surgery or chemotherapy. Patients will receive tamoxifen tablets daily for 4 weeks after which time a biopsy (sample of cancer tissue) will be taken at gastroscopy (a flexible camera that is passed into the mouth through the gullet into the stomach). The biopsy will be compared with the biopsy taken at the time of diagnosis to determine if tamoxifen has had any effect on cancer cell growth. If this study shows that tamoxifen does slow cancer cell growth it could lead to a larger study of patients with oesophageal cancer taking tamoxifen for a longer time period to determine if there is any clinical benefit.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Nottingham
• Treatments: Tamoxifen

Criteria

Inclusion Criteria:

• Patients with oesophageal cancer who are not candidates for surgical resection or further chemotherapy.

• Men aged 18 - 95.

• Women aged 55 - 95.

• Patients who have a biopsy specimen of the cancer stored in the laboratory from the time of diagnosis.

• The patient agrees and is able to return to the same research facility for the gastroscopy.

• The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical site.

Exclusion Criteria:

• Chemotherapy within 4 weeks of entry into the trial.

• Life expectancy <4 weeks

• Concurrent hormonal therapy e.g. Any SERMs, Hormone Replacement Therapy, Oral Contraceptive, or within 4 weeks of entry into the trial.

• Concurrent anticoagulant therapy other than Aspirin.

• Concurrent aminoglutethimide, and droperidol drugs.

• Previous thromboembolic disease (DVT/ PE), stroke or transient-ischemic attack.

• A positive family history (first-degree relative) of confirmed idiopathic venous thromboembolic events (DVT/ PE).

• Bleeding diathesis or thrombocytopenia.

• Women of childbearing age/ pre-menopause (<55 years of age).

• Any other medical condition, which in the opinion of the investigator should be excluded from the study.