A Clinical Trial Testing Rapamycin, an mTOR-inhibitor, in Combination With Preoperative Radiotherapy in Operable Rectum Cancer: a Phase I and II Study
N/A
N/A
Both
Rectum Cancer
Trial Information
A Clinical Trial Testing Rapamycin, an mTOR-inhibitor, in Combination With Preoperative Radiotherapy in Operable Rectum Cancer: a Phase I and II Study
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 of 6 mg will be given once a day.
Preoperative radiotherapy (5x 5 Gy) will be administered at day 8-12, followed by
TME-surgery at day 15.
Phase II A daily dose of 6 mg Rapamycin will be taken for 14 days (unless the optimal dose
found in the phase I study is lower).
Preoperative radiotherapy (5x 5 Gy) will be administered at day 9-15, followed by
TME-surgery 7-8 weeks post RT.
Sample size Phase I dose-escalation study Minimum 3 eligible patients per step, maximum 6
eligible patients per step. Phase II A total of 47 patients will be entered in this part of
the study.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Phase I: Incidence of severe postoperative complications (grade IV or grade V),
Outcome Time Frame:
within the first 6 weeks after surgery
Safety Issue:
Yes
Principal Investigator
Guido Lammering
Investigator Role:
Principal Investigator
Investigator Affiliation:
Maastricht Radiation Oncology
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
04-16
NCT ID:
NCT00409994
Start Date:
September 2006
Completion Date:
June 2015
Related Keywords:
- Rectum Cancer
- Colorectal cancer
- M-tor inhibitor
- Rapamycin
- Rectal Neoplasms
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