Status:
COMPLETED
Temsirolimus and Irinotecan for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations
Lead Sponsor:
Vejle Hospital
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate the safety and efficacy of temsirolimus as a single drug, and of temsirolimus in combination with irinotecan in chemotherapy resistant patients with KRAS mu...
Detailed Description
Chemotherapy resistance is a major challenge in metastatic colorectal cancer (mCRC), and EGFR inhibitors have been introduced as 3rd line treatment to chemotherapy refractory patients. However, it has...
Eligibility Criteria
Inclusion
- Histologically verified colorectal adenocarcinomas
- Age \> 18 years and \< 70
- Metastatic colorectal cancer refractory 5-FU, oxaliplatin and irinotecan containing treatment regimes
- KRAS mutation detected by DxS kit in primary tumor or metastatic lesion.
- Measurable disease according to RECIST
- ECOG performance status 0, 1 or 2
- Adequate renal, hepatic and haematological function
- Normal serum cholesterol and triglycerides
- Blood samples and available paraffin embedded tumor material for translational research studies
- Fertile males and females (\< 2 years after last period for women) must use effective birth control
- Signed Informed consent
Exclusion
- Clinically significant heart disease, active severe infections or other concurrent disease
- Other malignant diseases within 5 years of inclusion in the study, except basal cell squamous cell carcinoma of the skin and cervical carcinoma-in-situ
- Prior radiotherapy within 30 days of treatment start
- Other experimental therapy within 30 days of treatment initiation
- Patients who are breast feeding, childbearing or of childbearing potential without using dual effective contraception
- Clinical or radiological evidence of CNS metastasis
- Completed any major surgery, excision biopsy or significant traumatic lesion ≥ 4 weeks from start of treatment and completed any minor surgery ≥ 1 week prior to start of treatment
- Insertion of a vascular access device is not considered major or minor surgery from the viewpoint of protocol eligibility
- Patients must have fully recovered from the procedure and have a fully healed incision
- Planned radiation therapy against target-lesions
- Patients with significant non-healing wounds or ulcers
- History or evidence of thrombotic or hemorrhagic disorders
- Significant haemorrhage (\> 30 ml/bleeding episode in previous 3 months)
- Haemoptysis (\> 5 ml fresh blood in previous 4 weeks)
- Patients on full-dose anticoagulation (e.g., warfarin) are eligible provided that both of the following criteria are met:
- The patient has an in-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or is on a stable dose of low molecular weight heparin
- The patient has no active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
- Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA) or Sub-Arachnoid Hemorrhage (SAH) within 12 months prior to randomization
- No known or history of HIV seropositivity
- The use of ACE inhibitors is not permitted during the study
- Known allergy to temsirolimus, sirolimus, polysorbate 80 or included agents.
- Agents with strong CYP3A4-inhibitory potential
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00827684
Start Date
March 1 2009
End Date
June 1 2011
Last Update
June 8 2011
Active Locations (2)
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1
Rigshospitalet, Department of Oncology
Copenhagen, Denmark, DK-2100
2
Vejle Hospital, Dept. of Oncology
Vejle, Denmark