Radical Lung Radiotherapy Plus Nelfinavir (NelfLung)

This study has been withdrawn prior to enrollment.
(failed to recruit, no suitable patients)
Sponsor:
Information provided by (Responsible Party):
Linda Ward, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01447589
First received: July 18, 2011
Last updated: March 28, 2013
Last verified: March 2013

July 18, 2011
March 28, 2013
February 2012
October 2012   (final data collection date for primary outcome measure)
maximum tolerated dose [ Time Frame: One year ] [ Designated as safety issue: Yes ]
To establish the maximum tolerated dose of nelfinavir in combination with radical radiotherapy for patients with non-small cell lung cancer
Same as current
Complete list of historical versions of study NCT01447589 on ClinicalTrials.gov Archive Site
  • Number of participants with adverse events [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    To assess the safety profile of combined nelfinavir together with radiotherapy in patients with NSCLC.
  • Radiotherapy control rate [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
    To determine in-field radiotherapy treatment control rate at 3 and 12 months post treatment.
Same as current
Not Provided
Not Provided
 
Radical Lung Radiotherapy Plus Nelfinavir
A Phase I Dose Escalation Study of the HIV Protease Inhibitor, Nelfinavir, Given Concomitantly With Radical Radiotherapy (RT) for the Treatment of Non-Small Cell Lung Cancer (NSCLC)

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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Drug: 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.
    Other Name: Viracept®
  • Radiation: Radical Radiotherapy
    Total dose of 66 Gy delivered in 33 fractions (2.0 Gy/fraction) to the primary tumour plus a margin.
Experimental: Nelfinavir plus radical radiotherapy
Nelfinavir given in combination with radical RT
Interventions:
  • Drug: nelfinavir
  • Radiation: Radical Radiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01447589
EP-TSC-651
No
Linda Ward, Oxford University Hospitals NHS Trust
Oxford University Hospitals NHS Trust
Not Provided
Principal Investigator: Katherine Vallis University of Oxford and Oxford Radcliffe NHS Trust
Oxford University Hospitals NHS Trust
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP