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

NCT00409994 | Completed Phase 1 DMC

• 1 other identifier: 04-16
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Rectum Cancer

Keywords

Colorectal cancer; M-tor inhibitor; Rapamycin

Outcome Measures

Primary Outcomes (3)

• Phase I: Incidence of severe postoperative complications (grade IV or grade V),

  within the first 6 weeks after surgery

• assessed according to CTCv3.0

  within the first 6 weeks after surgery

• Phase II: Tumour blood flow assessed CT-PET + CTp

  day 64

Secondary Outcomes (4)

• Phase I:Incidence of other acute toxicity, assessed according to CTCv 3.0

  within the first 6 weeks after surgery

• Activation status of mTor related and dependent molecules in the tumour

  within the first 6 weeks after surgery

• Phase II:Maximum standardised Uptake Value (SUV) of 18F-FDG, assessed bij PET-CT-scan

  day 64

• Phase II:Incidence of acute side effects of rapamycin, assessed according to CTCv 4.0

  day 8, 15, 22, 36, 50 and 64

Study Arms (1)

Rapamycine

EXPERIMENTAL

rapamycine 6 mg dd

Drug: Rapamycin

Interventions

Rapamycin DRUG

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

Also known as: Sirolimus

Rapamycine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead
• Academisch Ziekenhuis Maastricht: collaborator

Study Sites (1)

Maastricht Radiation Oncology

Maastricht, Limburg, 6202 AZ, Netherlands

Location

MeSH Terms

Conditions

Rectal Neoplasms; Colorectal Neoplasms

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Jeroen Buijsen, MD PhD

  Maastricht Radiation Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2006
• First Posted: December 12, 2006
• Study Start: September 1, 2006
• Primary Completion: August 3, 2018
• Study Completion: December 1, 2018
• Last Updated: March 18, 2019

Record last verified: 2019-03

Locations

NL (1)