OXTOX: Can Oxaliplatin neurotoxicity be reduced with ibudilast in people with metastatic colorectal cancer – a phase II randomised study

Phase 2

Recruiting

• Conditions: eurotoxicity caused by oxaliplatin in patients with metastatic colorectal cancer; Neurotoxicity caused by oxaliplatin in patients with metastatic colorectal cancer; Cancer - Bowel - Back passage (rectum) or large bowel (colon); Neurological - Other neurological disorders

• Registration Number: ACTRN12619000566134
• Lead Sponsor: Australasian Gastro-Intestinal Trials Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-10
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Diagnosis of histologically confirmed metastatic adenocarcinoma CRC who are to commence chemotherapy with oxaliplatin (i.e. FOLFOX or CAPOX).
Agents such as Bevacizumab may be included with the oxaliplatin regimen.
Patients who are to receive an oxaliplatin regimen prior to planned surgery for metastatic CRC may be included if a minimum of 3 months of oxaliplatin treatment is planned.
Speak and read sufficient English to answer the questionnaires.
Adequate organ function, defined as renal function with glomerular filtration rate >50mL/min, adequate bone marrow (platelets >100 X 109 L-1, neutrophil count >1.5 X 109 L-1), and hepatic (ALT, AST or total bilirubin <3 X the upper limit of normal (ULN).
Give written informed consent.
Concomitant use of analgesics that are being used for purposes other than peripheral neuropathy but that have efficacy in neuropathy pain such as gabapentin and pregabalin and selective serotonin reuptake inhibitors (SSRIs), are allowed as long as the dose is expected to be consistent throughout the trial.

Exclusion Criteria

ECOG Performance Status of 3 or above.
Existing peripheral neuropathy of any grade (e.g. due to diabetes mellitus, B12 deficiency, alcohol abuse, or use of nucleoside reverse transcriptase inhibitors).
Prior adjuvant treatment with oxaliplatin within the past 12 months; or any prior treatment with oxaliplatin for metastatic disease regardless of the time frame.
Any major active psychiatric illness, dementia, or alcohol abuse that in the opinion of the principal investigator may interfere with their ability to complete neurotoxicity assessments.
Any contraindication to taking ibudilast, including uncontrolled nausea or vomiting with chemotherapy.
Inability to swallow capsules.

Study & Design

• Study Type: Interventional
• Study Design: Not specified