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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rectum Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rapamycine

rapamycine 6 mg dd

Group Type EXPERIMENTAL

Rapamycin

Intervention Type DRUG

dosis escalation: 2/4/6 mg rapamycin tablets, once daily during 13 days

Interventions

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Rapamycin

dosis escalation: 2/4/6 mg rapamycin tablets, once daily during 13 days

Intervention Type DRUG

Other Intervention Names

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Sirolimus

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No