Status:
COMPLETED
Nelfinavir, a Phase I/Phase II Rectal Cancer Study
Lead Sponsor:
Maastricht Radiation Oncology
Conditions:
Colorectal Cancer
Colorectal Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 w...
Detailed Description
Objective of the study: The aim is to study safety and activity of nelfinavir, added to standard chemoradiotherapy (28x1.8 Gy and capecitabine 825 mg/m2 BID) in patients with locally advanced rectal ...
Eligibility Criteria
Inclusion
- 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
- the opposite of the above
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00704600
Start Date
September 1 2008
End Date
July 1 2013
Last Update
December 8 2014
Active Locations (1)
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1
Maastro clinic
Maastricht, Netherlands, 6229 ET