Safety Study of Rapamycin Administered Before and During Radiotherapy to Treat Rectum Cancer
This study is currently recruiting participants.
Verified April 2012 by Maastricht Radiation Oncology
Sponsor:
Maastricht Radiation Oncology
Collaborator:
Academisch Ziekenhuis Maastricht
Information provided by:
Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:
NCT00409994
First received: December 11, 2006
Last updated: April 19, 2012
Last verified: April 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rectum Cancer |
Drug: Rapamycin |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Clinical Trial Testing Rapamycin, an mTOR-inhibitor, in Combination With Preoperative Radiotherapy in Operable Rectum Cancer: a Phase I and II Study |
Resource links provided by NLM:
Further study details as provided by Maastricht Radiation Oncology:
Primary Outcome Measures:
- Phase I: Incidence of severe postoperative complications (grade IV or grade V), [ Time Frame: within the first 6 weeks after surgery ] [ Designated as safety issue: Yes ]
- assessed according to CTCv3.0 [ Time Frame: within the first 6 weeks after surgery ] [ Designated as safety issue: No ]
- Phase II: Tumour blood flow assessed CT-PET + CTp [ Time Frame: day 64 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Phase I:Incidence of other acute toxicity, assessed according to CTCv 3.0 [ Time Frame: within the first 6 weeks after surgery ] [ Designated as safety issue: No ]
- Activation status of mTor related and dependent molecules in the tumour [ Time Frame: within the first 6 weeks after surgery ] [ Designated as safety issue: No ]
- Phase II:Maximum standardised Uptake Value (SUV) of 18F-FDG, assessed bij PET-CT-scan [ Time Frame: day 64 ] [ Designated as safety issue: No ]
- Phase II:Incidence of acute side effects of rapamycin, assessed according to CTCv 4.0 [ Time Frame: day 8, 15, 22, 36, 50 and 64 ] [ Designated as safety issue: No ]
- Activation status of mTOR related and dependent molecules in the tumour [ Time Frame: within the first 6 weeks after surgery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 65 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Rapamycin
dosis escalation: 2/4/6 mg rapamycin tablets, once daily during 13 days
Other Name: Sirolimus
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00409994
Contacts
| Contact: Philippe Lambin, Prof, MD PHD | +31 (0) 88 44 55 666 | philippe.lambin@maastro.nl |
| Contact: Guido Lammering, MD PhD | =31 (0) 88 44 55 666 | guido.lammering@maastro.nl |
Locations
| Netherlands | |
| Maastricht Radiation Oncology | Recruiting |
| Maastricht, Limburg, Netherlands, 6202 AZ | |
| Contact: Guido Lammering +31 (0) 88 44 55 666 guido.lammering@maastro.nl | |
| Contact: Jos Jager +31 (0) 88 44 55 666 jos.jager@maastro.nl | |
| Principal Investigator: Guido Lammering | |
Sponsors and Collaborators
Maastricht Radiation Oncology
Academisch Ziekenhuis Maastricht
Investigators
| Principal Investigator: | Guido Lammering | Maastricht Radiation Oncology |
More Information
No publications provided
| Responsible Party: | prof.dr. Ph. Lambin, MAASTRO clinic |
| ClinicalTrials.gov Identifier: | NCT00409994 History of Changes |
| Other Study ID Numbers: | 04-16 |
| Study First Received: | December 11, 2006 |
| Last Updated: | April 19, 2012 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Maastricht Radiation Oncology:
|
Colorectal cancer M-tor inhibitor Rapamycin |
Additional relevant MeSH terms:
|
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Sirolimus |
Everolimus Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on June 18, 2013