Duloxetine for Colorectal Cancer
Recruiting at 858 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Alliance for Clinical Trials in Oncology
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries
Trial Summary
What is the purpose of this trial?
This phase II/III trial studies the best dose of duloxetine and how well it works in preventing pain, tingling, and numbness (peripheral neuropathy) caused by treatment with oxaliplatin in patients with stage II-III colorectal cancer. Duloxetine increases the amount of certain chemicals in the brain that help relieve depression and pain. Giving duloxetine in patients undergoing treatment with oxaliplatin for colorectal cancer may help prevent peripheral neuropathy.
Will I have to stop taking my current medications?
Yes, you may need to stop taking certain medications. You cannot use other drugs for peripheral neuropathy, certain antidepressants, or serotonin-altering agents. Some medications must be stopped at least 7 to 14 days before starting the trial.
What safety data exists for Duloxetine in humans?
How does the drug Duloxetine differ from other treatments for colorectal cancer?
Duloxetine is primarily known as an antidepressant and is not a standard treatment for colorectal cancer. Its use in this context is unique and experimental, potentially exploring its effects on cancer-related symptoms or side effects rather than directly targeting cancer cells like traditional chemotherapy drugs.678910
Research Team
EM
Ellen M. Lavoie Smith, PhD
Principal Investigator
The University of Alabama at Birmingham School of Nursing
Eligibility Criteria
This trial is for stage II-III colorectal cancer patients who are about to receive oxaliplatin treatment and have no prior neurotoxic chemotherapy, pre-existing neuropathy, seizure disorders, glaucoma, severe psychiatric conditions or substance abuse. They must not be on certain medications like MAOIs or strong CYP1A2 inhibitors and should not be pregnant.Inclusion Criteria
I have stage II-III colorectal cancer and will start a specific chemotherapy regimen soon.
I do not have any nerve damage from any cause.
No serious eating disorder such as bulimia or anorexia
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Exclusion Criteria
I am not taking medications like gabapentin for nerve pain and can stop them 7 days before treatment.
I stopped taking MAOI or other antidepressants 14 days before starting the treatment.
I am not taking strong medications that affect liver enzymes CYP1A2 and CYP2D6.
See 5 more
Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive duloxetine or placebo alongside standard oxaliplatin treatment to prevent peripheral neuropathy
17 weeks
Weekly visits for monitoring and administration
Follow-up
Participants are monitored for safety and effectiveness after treatment
18 months
Follow-up visits at 30 days, 3, 6, 12, and 18 months post-treatment
Treatment Details
Interventions
- Duloxetine
Trial OverviewThe trial is testing whether duloxetine can prevent peripheral neuropathy (pain, tingling, numbness) in patients receiving oxaliplatin for colorectal cancer. It involves comparing the effects of duloxetine with a placebo while monitoring quality-of-life through questionnaires.
Participant Groups
5Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase III, Arm I (duloxetine hydrochloride)Experimental Treatment5 Interventions
Patients in Phase III receive most promising dose of duloxetine hydrochloride from Phase II PO QD in the absence of unacceptable toxicity.
Group II: Phase II, Arm II (duloxetine hydrochloride)Experimental Treatment5 Interventions
Patients in Phase II receive duloxetine hydrochloride 30 mg (1 duloxetine capsule) orally (PO) once daily (QD) during week 1, duloxetine hydrochloride 60 mg (2 duloxetine capsules) PO QD during weeks 2-16, followed by duloxetine hydrochloride 30 mg (1 duloxetine capsule) PO QD during week 17 in the absence of unacceptable toxicity.
Group III: Phase II, Arm I (duloxetine hydrochloride, placebo)Experimental Treatment6 Interventions
Patients in Phase II receive duloxetine hydrochloride 30 mg (1 duloxetine capsule) orally (PO) once daily (QD) during week 1, duloxetine hydrochloride 30 mg (1 duloxetine capsule) PO QD and placebo (1 placebo capsule) PO QD during weeks 2-16, followed by duloxetine hydrochloride 30 mg (1 duloxetine capsule) PO QD during week 17 in the absence of unacceptable toxicity.
Group IV: Phase II, Arm III (placebo)Placebo Group4 Interventions
Patients in Phase II receive placebo (1 placebo capsule) orally (PO) once daily (QD) during week 1, placebo (2 placebo capsules) PO QD weeks 2-16, followed by placebo (1 placebo capsule) PO QD during week 17 in the absence of unacceptable toxicity.
Group V: Phase III, Arm II (placebo)Placebo Group4 Interventions
Patients in Phase III receive placebo PO QD in the absence of unacceptable toxicity.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alliance for Clinical Trials in Oncology
Lead Sponsor
Trials
521
Recruited
224,000+
National Cancer Institute (NCI)
Collaborator
Trials
14,080
Recruited
41,180,000+
Findings from Research
In a large post-marketing surveillance study of 301 patients with colorectal cancer, gastrointestinal stromal tumors, and hepatocellular carcinoma, regorafenib was found to have a high incidence of adverse events (85% for CRC), with palmar-plantar erythrodysesthesia syndrome being the most common side effect, but no new safety concerns were identified.
The effectiveness of regorafenib varied by cancer type, showing an overall response rate of 4.7% for CRC, 0% for GIST, and 41.4% for HCC, with median progression-free survival of 2.1 months for CRC and 9.2 months for GIST, indicating that while it is generally safe, its efficacy can differ significantly among different cancers.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Real-world experience of safety and effectiveness of regorafenib for treatment of metastatic colorectal cancer, advanced gastrointestinal stromal tumors, and hepatocellular carcinoma: a post-marketing surveillance study in Korea.Beom, SH., Bae, KB., Zang, DY., et al.[2022]
The maximum tolerated dose (MTD) for the combination of erlotinib, capecitabine, and oxaliplatin in metastatic colorectal cancer (MCRC) was established as capecitabine 825 mg/m² twice daily, oxaliplatin 130 mg/m² on day 1, and erlotinib 100 mg daily, with the regimen showing good tolerability and no unexpected adverse events.
Antitumor activity was observed in the trial, with one complete response, four partial responses, and stable disease in 11 patients, indicating that this combination therapy may be effective and warrants further investigation.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A phase Ib dose-escalation study of erlotinib, capecitabine and oxaliplatin in metastatic colorectal cancer patients.Van Cutsem, E., Verslype, C., Beale, P., et al.[2020]
The XELOX30 regimen, which combines capecitabine and a shorter 30-minute infusion of oxaliplatin, was tested in 70 patients with advanced colorectal cancer resistant to irinotecan, showing a response rate of 17% and a median survival of 9.5 months.
The treatment demonstrated a moderate level of neurotoxicity, with 56% of patients experiencing grade 1 and 17% grade 2 neuropathy, indicating that XELOX30 is a convenient and effective second-line therapy with a safety profile comparable to longer infusion schedules.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Short-time infusion of oxaliplatin in combination with capecitabine (XELOX30) as second-line therapy in patients with advanced colorectal cancer after failure to irinotecan and 5-fluorouracil.Pfeiffer, P., Sørbye, H., Ehrsson, H., et al.[2020]
References
Unexpected side effect in mCRC: A care-compliant case report of regorafenib-induced hyperammonemic encephalopathy. [2022]
Real-world experience of safety and effectiveness of regorafenib for treatment of metastatic colorectal cancer, advanced gastrointestinal stromal tumors, and hepatocellular carcinoma: a post-marketing surveillance study in Korea. [2022]
Efficacy, Safety and Cost of Regorafenib in Patients with Metastatic Colorectal Cancer in French Clinical Practice. [2022]
Phase II study of reintroduction of oxaliplatin for advanced colorectal cancer in patients previously treated with oxaliplatin and irinotecan: RE-OPEN study. [2022]
Sex and Regorafenib Toxicity in Refractory Colorectal Cancer: Safety Analysis of the RegARd-C Trial. [2022]
Fluorouracil and bevacizumab plus anakinra for patients with metastatic colorectal cancer refractory to standard therapies (IRAFU): a single-arm phase 2 study. [2021]
A phase Ib dose-escalation study of erlotinib, capecitabine and oxaliplatin in metastatic colorectal cancer patients. [2020]
Efficacy and safety of anlotinib plus XELOX regimen as first-line therapy for mCRC: a single-arm, multicenter, phase II study (ALTER-C-001). [2023]
Short-time infusion of oxaliplatin in combination with capecitabine (XELOX30) as second-line therapy in patients with advanced colorectal cancer after failure to irinotecan and 5-fluorouracil. [2020]
[Regorafenib in patients with metastatic colorectal cancer: a review and an update]. [2016]
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