Status:
COMPLETED
Safety Study of Rapamycin Administered Before and During Radiotherapy to Treat Rectum Cancer
Lead Sponsor:
Maastricht Radiation Oncology
Collaborating Sponsors:
Academisch Ziekenhuis Maastricht
Conditions:
Rectum Cancer
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
Brief Summary
Investigating the safety and the activity of Rapamycin, administered before and during preoperative radiotherapy in patients with an operable colorectal carcinoma. The phase I dose escalation study wi...
Detailed Description
Treatment regimen Phase I A daily dose of Rapamycin will be taken during 13 days. At step 1 a dose of 2 mg will be given once a day; at step 2 a dose of 4 mg will be given once a day; at step 3 a dose...
Eligibility Criteria
Inclusion
- Histologically proven rectum cancer
- UICC TNM I-III
- WHO performance status 0-2
- Less than 10% weight loss the last 6 months
- No recent (\< 3 months) severe cardiac disease
- Normal serum bilirubin and serum creatinin
Exclusion
- Concurrent chemotherapy with radiation
- History of prior pelvis radiotherapy
- Recent (\<3 months) myocardial infarction
- Uncontrolled infectious disease
- Concurrent medication known as inhibitors of CYP3A4 susceptible to increase Rapamycin blood concentrations
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00409994
Start Date
September 1 2006
End Date
December 1 2018
Last Update
March 18 2019
Active Locations (1)
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1
Maastricht Radiation Oncology
Maastricht, Limburg, Netherlands, 6202 AZ