Tamoxifen in Patients With Oesophageal Cancer

NCT02513849 | Unknown Phase 1

• 2 other identifiers: 15021163909
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cancer; Gastrointestinal Neoplasms

Keywords

esophagus; gastroscopy; tamoxifen

Outcome Measures

Primary Outcomes (1)

• A change in Ki67 expression following tamoxifen therapy, by comparing the pre- and post- tamoxifen biopsies

  A change in Ki67 expression will be determined by immunohistochemistry on the specimens which will be fixed in formaldehyde and processed into paraffin blocks.

  1.5 years

Secondary Outcomes (2)

• A change in ER-α expression

  1.5 years

• A change in ER-β expression

  1.5 years

Study Arms (1)

Tamoxifen treatment

EXPERIMENTAL

Patients will be administered tamoxifen, 80mg/ day orally for 4 days as a loading dose, followed by 20mg/ day thereafter until gastroscopy and biopsy 4 weeks later.

Drug: Tamoxifen

Interventions

Tamoxifen DRUG

Daily tamoxifen tablet for approximately 4 weeks

Also known as: Tamoxifen Citrate

Tamoxifen treatment

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (2)

Graduate Entry Medical School, University of Nottingham

Derby, Derbyshire, DE33 2NE, United Kingdom

RECRUITING

Royal Derby Hospital

Derby, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neoplasms; Gastrointestinal Neoplasms

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Raheela Khan

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonella De Rosa, MBChB

CONTACT

01332724868; mzxad@nottingham.ac.uk

Raheela Khan

CONTACT

01332724664; raheela.khan@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2015
• First Posted: August 3, 2015
• Study Start: December 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: November 1, 2018
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

GB (2)