Status:
TERMINATED
Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy In Subjects With Advanced Colorectal Cancer
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Chemotherapy-Induced Peripheral Neuropathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Prevention and treatment of the severity of symptoms of chemotherapy-induced peripheral neuropathy.
Detailed Description
This study was terminated on July 15, 2008. The results of an interim analysis showed that the conditional power to detect a difference in treatment groups was insufficient to warrant study continuati...
Eligibility Criteria
Inclusion
- Diagnosis of cytological confirmed carcinoma of the Colon Stage III (Dukes C) or metastatic Colorectal Cancer (Dukes D)
- Independent of this protocol, the patient has decided to receive standard of care for the treatment of cancer with oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA) for a minimum of 9 cycles
Exclusion
- Presence of neuropathic pain or peripheral polyneuropathy or identified causes of painful paresthesia including radiotherapy-induced or malignant plexopathy, lumbar or cervical radiculopathy existing prior to baseline
- Any patients who are not suitable to be treated with either Oxaliplatin and/or 5-FU/FA or pregabalin according to the respective local labeling
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00380874
Start Date
January 1 2007
End Date
March 1 2008
Last Update
February 11 2021
Active Locations (15)
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1
Pfizer Investigational Site
St Leonards, New South Wales, Australia, 2065
2
Pfizer Investigational Site
Adelaide, South Australia, Australia, 5000
3
Pfizer Investigational Site
Bielefeld, Germany, 33611
4
Pfizer Investigational Site
Essen, Germany, 45122