The Potentiation of Efficacy of Radiotherapy in Non-Small-Cell Lung Cancer (NSCLC) by Inhibition of Akt Activation - Lung Radiotherapy and Nelfinavir

Institute of Cancer Research0 sites64 target enrollmentSeptember 18, 2006

Overview

No summary available.

Registry

who.int

Start Date

September 18, 2006

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- Histologically verified NSCLC including squamous cell carcinoma, adenocarcinoma, and large cell anaplastic carcinoma
•\- Patients with stage II or III NSCLC unsuitable for radical treatment to the primary tumour, where high dose palliative radiotherapy is considered appropriate (CT scan to have been performed within 28 days prior to trial entry)
•\- Performance status WHO 0 \- 2
•\- clinically or radiographically measurable disease
•\- absolute neutrophil count \>\=1500/mm3
•\- Platelets \=100 x 109/L (\=100000/mm3\)
•\- Serum creatinine \=1\.5 times upper limit of normal
•\- Bilirubin \=1\.5 times upper limit of normal
•\- Serum AST \= 1\.5 x upper limit of normal
•Are the trial subjects under 18? no

•\- Patients with metastatic disease
•\- Patients diagnosed with heart disease or diabetes mellitus
•\- Previous radiotherapy to the chest
•\- Chemotherapy within 4 weeks of the start of experimental treatment
•\- The presence of another malignancy, where the extent of disease or treatment for that condition may interfere with the study endpoints
•\- Patients already taking a Protease Inhibitor
•\- Patients taking drugs contraindicated with NFV, unless stopped 2 weeks or more before start of study:
•Antiarrhythmics amiodarone, quinidine
•Antimycobacterials rifampicin
•Ergot derivatives Dihydroergotamine, ergonovine, ergotamine, methylergonovine