Colorectal Cancer Clinical Trial
— NelfinavirOfficial title:
A Phase I/II Trial Testing Nelfinavir, an Inhibitor of Akt Signaling, in Combination With Preoperative Chemoradiotherapy in Patients With Locally Advanced Rectal Cancer
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
Status | Completed |
Enrollment | 15 |
Est. completion date | July 2013 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastro clinic | Maastricht |
Lead Sponsor | Collaborator |
---|---|
Maastricht Radiation Oncology |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | phase I: Incidence of any grade 3 or higher non-hematological or grade 4 or higher hematological toxicity (CTCAE v3.0) and of grade 4 or higher postoperative toxicity within 30 days post-surgery phase II:rate of pathological complete remission | 22 wks | Yes |
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