rectal cancer
Conditions
Interventions
Phase I:
- take nelfinavir tablets (minimum 6, maximum 10) starting 7 days before start
of chemoradiotherapy, for 35 days
- day 7 and week 2-4-6 bloodsamples
Phase II:
- take XXXX ( to define ) nel
Sponsors
MAASTRO clinic
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Histologically proven adenocarcinoma of the rectum (tumor = 18 years • UICC T3-4 N0-2 M0 • WHO performance status 0-2 • Less than 10 % weight loss the last 6 months • No recent (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
Exclusion criteria: the opposite of the above
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: incidence of any grade 3 or higher non-hematological or grade 4 or higher hematological toxicity and incidence of grade 4 or higher postoperative toxicity within 30 days post-surgery Phase II: the rate of pathological complete remission (pCR) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Progression free and overall survival - Local and distant recurrence rate - Metabolic response rate on CT-PET at time of surgery - Phosphorylation of Akt in the tumor at different time points - Tumor perfusion assessed by dynamic CT-scan | — |
Countries
Netherlands
Outcome results
None listed