Nelfinavir, a Phase I/Phase II Rectal Cancer Study

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim is to study safety and activity of nelfinavir , added to standard chemoradiotherapy in patients with locally advanced rectal cancer. Furthermore analysis of the effect of nelfinavir combined with chemoradiation on tumour tissue will be studied

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maastricht Radiation Oncology
• Treatments: Nelfinavir

Criteria

Inclusion Criteria:

• Histologically proven adenocarcinoma of the rectum (tumor <15cm from anal verge)

• Age >= 18 years

• UICC T3-4 N0-2 M0

• WHO performance status 0-2

• Less than 10 % weight loss the last 6 months

• No recent (< 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction)

• Serum bilirubin = or < 3x normal

• ASAT and ALAT = or < 2,5x normal

• Creatinin clearance >50 ml/min

• Willing and able to comply with the study prescriptions

• No history of prior pelvic radiotherapy

• No known HIV infection

• No hemophilia

• No concurrent medication that is metabolized by the CYP3A4 isoenzyme (calcium channel blockers, antifungal agents, macrolide antibiotics, gastrointestinal prokinetics, terfenadin, midazolam)

• Statins should be stopped (except pravastatin and fluvastatin),

• No concurrent use of St. John's Wort (Hypericum perforatum)

• Women should not be pregnant or lactating

• Being willing and able to undergo one extra biopsy

• Have given written informed consent before patient registration

Exclusion Criteria:

• the opposite of the above