Overview

Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy In Subjects With Advanced Colorectal Cancer

Status:
Terminated

Trial end date:
2008-03-01

Target enrollment:
0

Participant gender:
All

Summary

Prevention and treatment of the severity of symptoms of chemotherapy-induced peripheral neuropathy.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Pfizer
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatments:

Pregabalin

Criteria

Inclusion Criteria:

- 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 Criteria:

- 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