Safety Study of Rapamycin Administered Before and During Radiotherapy to Treat Rectum Cancer

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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 will be performed in three steps (2, 4 and 6 mg). Patients entered in phase II will follow the same tolerable treatment regimen as patients in phase I study.

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

Details

• Lead Sponsor: Maastricht Radiation Oncology
• Collaborator: Academisch Ziekenhuis Maastricht
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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