Status:
COMPLETED
Endoscopic Treatment of Inoperable Colorectal Cancer With the EndoVe System
Lead Sponsor:
Mercy University Hospital, Cork, Ireland
Collaborating Sponsors:
St. James's Hospital, Ireland
The Adelaide and Meath Hospital
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A new approach to treating solid tumours (both operable and inoperable) has been carried out by the Cork Cancer Research Centre (CCRC) at the Mercy University Hospital, Cork, Ireland since 2002. The ...
Detailed Description
The objective is to conduct treatment in a minimally invasive manner (using the endoscope) and without the requirement for repeated doses of chemotherapy. The single dose of the drug used (15,000 IU/m...
Eligibility Criteria
Inclusion
- Histologically verified colorectal tumour.
- Case reviewed by a multidisciplinary team (MDT) (surgery, radiology, oncology, gastroenterology) and there are no curable options with the standard of care. The MDT considers all available treatment options and enrolment to this study is agreed as being appropriate; Or the case is curable but patient refuses to undergo the standard of care. The MDT considers all possible alternatives, which are also discussed with the patient, and the MDT considers enrolment to this study as being the most appropriate option; Or patients with advanced local disease with impending obstruction on endoscopic evaluation who are otherwise not suitable for surgical intervention or stenting, the MDT would also consider these patients for enrolment into this study.
- Men or women aged at least 18 years.
- Performance status (Karnofsky \> 60% or ECOG/WHO \< 2).
- Treatment free interval of at least 2 weeks after previously applied therapy.
- Patients must be mentally capable of understanding the information given.
- Patients must give written informed consent.
- a) A female of Non-Childbearing potential (i.e. physiologically incapable of becoming pregnant) is eligible to participate in the study if she:
- has had a hysterectomy
- has had a bilateral oophorectomy (ovariectomy) - has had a bilateral tubal ligation
- Is post-menopausal:
Exclusion
- Coagulation disorder
- Patients with pre-existing renal dysfunction are excluded. \[Note: Creatinine clearance will be measured for all patients. For Bleomycin treatment: creatinine clearance must be greater than 40ml/min.\]
- Patients with a clinically manifested arrhythmia or with a pacemaker
- Patients with epilepsy.
- Pregnancy or lactation/breastfeeding.
- Patient known to be Hepatitis B/C or HIV positive.
- Concurrent treatment with an investigational medicinal product or participation in another clinical study.
- Patients who have undergone a regime of Bevacizumab in the previous 4 weeks.
- Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements.
- Highly inflamed colon tissue which is ulcerated and bleeding.
- Additional exclusion criteria specifically regarding patients where Bleomycin is study drug:
- Contraindications for bleomycin use including acute pulmonary infection and severe pulmonary disease.
- Contraindication for bleomycin use: allergic reactions to bleomycin observed in previous treatment.
- Contraindication for bleomycin use: if cumulative dose of 250mg BLM/m2 was previously exceeded.
- Additional exclusion criteria specifically regarding patients where Cisplatin is study drug:
- Patients with hypersensitivity to Cisplatin or other platinum compounds or to any of the excipients are to be excluded from receiving Cisplatin for the study.
- Cisplatin is contraindicated in combination with live vaccines, including yellow fever vaccine.
- Cisplatin is contraindicated in combination with phenytoin in prophylactic use.
- Cisplatin is contraindicated in patients with myelosuppression.
- Cisplatin is contraindicated in patients in a dehydrated condition (pre- and post-hydration is required to prevent serious renal dysfunction).
- Cisplatin is contraindicated in patients with a pre-existing hearing impairment.
- Cisplatin is contraindicated in patients with neuropathy caused by cisplatin.
- Contraindication for Cisplatin use: Allergic reactions to Cisplatin observed in previous treatment.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01172860
Start Date
March 1 2010
End Date
September 1 2016
Last Update
November 9 2017
Active Locations (1)
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1
Mercy University Hospital
Cork, Ireland, cork4