Radical Lung Radiotherapy Plus Nelfinavir

NCT ID: NCT01447589

Last Updated: 2016-06-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-10-31

Brief Summary

The aim of this clinical trial is to test whether the drug nelfinavir, which can increase the effectiveness of radiotherapy, can be given safely at the same time as a full dose of radiotherapy for lung cancer.

It is thought that one way that nelfinavir works is through causing changes in the blood vessels within tumours. The status of tumour blood vessels and the blood flow through them will be investigated during the trial using special imaging techniques. The dose of radiation used in this trial is greater than that used in previous trials with nelfinavir in other disease settings and the response of normal lung to the combination of nelfinavir plus radiation is unknown. Therefore, a low dose of nelfinavir will be given to the first few patients that participate and will be gradually increased in subsequent groups of patients provided that no worrying side effects are identified. There is a single report of serious side-effects in an AIDs patient who was treated with radiotherapy for lung cancer when he was also taking nelfinavir. However, in this case nelfinavir was taken at a dose 3-fold higher than the highest dose level to be tested in this trial. An important goal of this trial is to select the optimum dose of nelfinavir to be used in combination with lung radiotherapy, that can then be tested more extensively in future trials.

The radiotherapy treatment in this trial has been carefully designed to minimise the amount of healthy lung that receives radiation. Some specialised imaging techniques will be used during radiotherapy planning and delivery to help ensure that the lung cancer is targeted very precisely by radiation and that normal lung is avoided as much as possible.

One effect of nelfinavir is to interfere with the function of a particular protein in cells (called AKT). The degree to which this happens can be measured in cells from blood or tissue samples. Therefore, another aim of the study is to investigate AKT and related proteins, to check whether nelfinavir is having the predicted effect.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nelfinavir plus radical radiotherapy

Nelfinavir given in combination with radical RT

Group Type: EXPERIMENTAL

nelfinavir

Intervention Type: DRUG

Nelfinavir tablets BD 7 days per week from D-7 of starting radiotherapy until completion of radiotherapy on D47. 3 dose levels: 750 mg bd; 1000 mg bd; and 1250 mg bd.

Radical Radiotherapy

Intervention Type: RADIATION

Total dose of 66 Gy delivered in 33 fractions (2.0 Gy/fraction) to the primary tumour plus a margin.

Interventions

nelfinavir

Nelfinavir tablets BD 7 days per week from D-7 of starting radiotherapy until completion of radiotherapy on D47. 3 dose levels: 750 mg bd; 1000 mg bd; and 1250 mg bd.

Intervention Type: DRUG

Radical Radiotherapy

Total dose of 66 Gy delivered in 33 fractions (2.0 Gy/fraction) to the primary tumour plus a margin.

Intervention Type: RADIATION

Other Intervention Names

Viracept®

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed NSCLC except bronchoalveolar cancer
• Patients deemed suitable for radical RT according to local policy
• TNM stage T1-2, N0-1, M0 plus patients with local recurrence
• Adequate lung function as defined by protocol
• Age ≥ 18 years
• ECOG performance status 0-2
• Written informed consent
• Patient able and willing to comply with all protocol requirements

Exclusion Criteria

• History of other active invasive malignancy (excluding non-melanoma skin cancer and in situ carcinoma of the cervix), where the extent of disease or treatment for that condition may interfere with the study endpoints
• Previous RT to the chest
• Chemotherapy, immunotherapies or investigational medicinal products within 4 weeks of the start of nelfinavir treatment. Ie any neoadjuvant treatment must be completed 4 weeks prior.
• Liver impairment (serum bilirubin ≥ 2 times upper limit of normal, serum AST ≥ 2 times the upper limit of normal)
• Pregnant or breast-feeding women or women of childbearing potential unless effective methods of contraception are used. Contraceptives that contain norethisterone or ethinylestradiol must be replaced by other contraceptive measures
• Concurrent use of contraindicated drugs that cannot be substituted or discontinued 2 weeks or more prior to the start of trial treatment
• Known hypersensitivity to nelfinavir or any of its excipients
• Other psychological, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Linda Ward

QA Coordinator, Cancer Centre

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katherine Vallis

Role: PRINCIPAL_INVESTIGATOR

University of Oxford and Oxford Radcliffe NHS Trust

Locations

Oxford Radcliffe NHS Trust

Oxford, Oxfordshire, United Kingdom

Countries

United Kingdom

Other Identifiers

EP-TSC-651

Identifier Type: -

Identifier Source: org_study_id