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Alcohol Deterrent

Disulfiram + Chemotherapy for Pancreatic Cancer

Phase 1
Waitlist Available
Led By Aminah Jatoi
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
Able to swallow or have medication administered through a gastrostomy tube (G-tube) and absorb the medication
Must not have
Baseline of grade 2 or worse peripheral sensory neuropathy
Known standard therapy for the patient's disease that is potentially curative
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from registration until death due to any cause, assessed up to 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying disulfiram given with chemotherapy to see if it can reduce tumor-induced muscle loss in patients with solid tumors that have not responded to treatment or pancreatic cancer that has spread to other parts of the body.

Who is the study for?
This trial is for adults with solid tumors that are untreatable by standard methods or metastatic pancreatic cancer. Participants must have acceptable blood counts, organ function, and be able to take oral medication. Women of childbearing potential must use effective contraception and not be pregnant or nursing. People can't join if they have curative treatment options available, uncontrolled illnesses, untreated brain metastases, certain neuropathy levels, or are using specific drugs like phenytoin.
What is being tested?
The study is testing the combination of Disulfiram (a drug potentially preventing muscle wasting) with chemotherapy (Gemcitabine Hydrochloride) in patients whose cancers haven't responded to other treatments. The goal is to find the safest dose of Disulfiram and see if it enhances chemotherapy's effectiveness while reducing muscle loss associated with cancer.
What are the potential side effects?
Possible side effects include those from Disulfiram such as fatigue, headache, metallic taste and possible liver issues; Gemcitabine may cause flu-like symptoms, bruising/bleeding tendencies due to low blood cell counts, shortness of breath and gastrointestinal upset.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to care for myself and perform daily activities.
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I can swallow pills or receive them through a G-tube.
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I have an incurable solid tumor with no effective standard treatment options.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have moderate to severe numbness or pain in my hands or feet.
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There is a known cure for my condition.
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I have brain metastases that have not been treated.
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I am currently taking phenytoin.
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I am currently breastfeeding.
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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from registration until death due to any cause, assessed up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from registration until death due to any cause, assessed up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum tolerated dose (MTD) (Cohort I)
Secondary study objectives
Adverse events profile (Cohort I and II)
X-Ray Computed Tomography
X-Ray Computed Tomography
+4 more
Other study objectives
Change in muscle protein expression level of total and phosphorylated (phosph)-signal transducer and activator of transcription 3 (STAT3) via immunohistochemistry
Changes in muscle messenger ribonucleic acid (mRNA) levels via real-time polymerase chain reaction

Side effects data

From 2014 Phase 4 trial • 45 Patients • NCT02000531
29%
Nausea
19%
Leukopenia
14%
Anaemia
14%
Vomiting
14%
Neutropenia
14%
Alanine aminotransferase increased
14%
White blood cell count decreased
14%
Thrombocytopenia
10%
Neutrophil count decreased
10%
Platelet count decreased
10%
Aspartate aminotransferase increased
5%
Musculoskeletal pain
5%
Dizziness
5%
Diarrhea
5%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erlotinib-Chemotherapy
Chemotherapy-Erlotinib

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort II (chemotherapy and disulfiram)Experimental Treatment3 Interventions
Patients receive chemotherapy at the discretion of the treating oncologist and disulfiram PO on days 1-28 or days 1-35.
Group II: Cohort I (gemcitabine hydrochloride and disulfiram)Experimental Treatment3 Interventions
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and disulfiram PO on days 1-28 or days 1-35.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Disulfiram
2008
Completed Phase 4
~1330
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Chemotherapy
2003
Completed Phase 4
~3050

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,318 Previous Clinical Trials
2,951,076 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,886 Previous Clinical Trials
41,020,946 Total Patients Enrolled
Aminah JatoiPrincipal InvestigatorMayo Clinic in Rochester
8 Previous Clinical Trials
246 Total Patients Enrolled

Media Library

Disulfiram (Alcohol Deterrent) Clinical Trial Eligibility Overview. Trial Name: NCT02671890 — Phase 1
Pancreatic Cancer Research Study Groups: Cohort I (gemcitabine hydrochloride and disulfiram), Cohort II (chemotherapy and disulfiram)
Pancreatic Cancer Clinical Trial 2023: Disulfiram Highlights & Side Effects. Trial Name: NCT02671890 — Phase 1
Disulfiram (Alcohol Deterrent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02671890 — Phase 1
~0 spots leftby Dec 2024
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