Your session is about to expire
← Back to Search
Alcohol Deterrent
Disulfiram + Chemotherapy for Pancreatic Cancer
Phase 1
Waitlist Available
Led By Aminah Jatoi, M.D.
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from registration until death due to any cause, assessed up to 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am able to care for myself and perform daily activities.
Select...
I can swallow pills or receive them through a G-tube.
Select...
I have an incurable solid tumor with no effective standard treatment options.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from registration until death due to any cause, assessed up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from registration until death due to any cause, assessed up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) (Cohort I)
Secondary outcome measures
Adverse events profile (Cohort I and II)
X-Ray Computed Tomography
X-Ray Computed Tomography
+4 moreOther outcome measures
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 • NCT0200053129%
Nausea
19%
Leukopenia
14%
White blood cell count decreased
14%
Vomiting
14%
Thrombocytopenia
14%
Alanine aminotransferase increased
14%
Anaemia
14%
Neutropenia
10%
Neutrophil count decreased
10%
Platelet count decreased
10%
Aspartate aminotransferase increased
5%
Dizziness
5%
Back pain
5%
Diarrhea
5%
Musculoskeletal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erlotinib-Chemotherapy
Chemotherapy-Erlotinib
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
~1300
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
3,205 Previous Clinical Trials
3,766,768 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,137 Total Patients Enrolled
Aminah Jatoi, M.D.Principal InvestigatorMayo Clinic in Rochester
9 Previous Clinical Trials
383 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot stop drinking alcohol during the study.Your bilirubin levels are not more than twice the normal limit.The level of a specific liver enzyme called AST is not more than 3 times the upper limit of normal. This test should be done within 7 days before joining the study.My blood clotting time is within the normal range required for a biopsy.You are expected to live for at least 12 more weeks.Your platelet count is at least 100,000 per cubic millimeter.I have metastatic pancreatic cancer and may have had previous treatments.I agree to have muscle biopsies before and after treatment as required, unless waived.You must use a contraceptive method such as condoms, diaphragm, hormonal methods, tubal ligation, partner's vasectomy, intrauterine device, or have a commitment to abstinence.I have moderate to severe numbness or pain in my hands or feet.I am not currently on any other cancer treatments or experimental drugs.There is a known cure for my condition.I am able to care for myself and perform daily activities.I have brain metastases that have not been treated.My oncologist believes I can undergo chemotherapy.I have taken a pregnancy test within the last week and it was negative.I am currently taking phenytoin.Your white blood cell count is at least 1500 per cubic millimeter.I can swallow pills or receive them through a G-tube.Your kidney function test results must show that the creatinine level is not more than 1.5 times the upper limit of normal.I have an incurable solid tumor with no effective standard treatment options.I am currently breastfeeding.Your hemoglobin level is at least 9.0 grams per deciliter, as measured within the last 7 days before joining the study.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.Women who can have babies must use a form of birth control that is approved by the study, like birth control pills with both estrogen and progestin, or condoms.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort I (gemcitabine hydrochloride and disulfiram)
- Group 2: Cohort II (chemotherapy and disulfiram)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What diseases are usually targeted with chemotherapy treatments?
"Small cell lung cancer is a common target of chemotherapy treatment, and this type of therapy may also prove helpful for other forms of carcinoma such as head and neck carcinomas, locally advanced pancreatic adenocarcinomas, and cervical cancers."
Answered by AI
Are participants currently being enlisted in this trial?
"According to clinicaltrials.gov, the trial is open for candidate registration; first posted on February 25th 2016 and most recently modified on June 1st 2022."
Answered by AI
What other experiments have been conducted in regards to Chemotherapy?
"As of today, the world has 452 active clinical trials assessing the efficacy of chemotherapy. 134 studies are located in Phase 3 and 24571 sites worldwide offer these medical treatments. The majority of locations for Chemotherapy-related research is found in Woolloongabba, Queensland."
Answered by AI
Is there a regulatory indication for utilizing Chemotherapy?
"The safety of Chemotherapy is rated a 1 on our internal scale, as this trial is in its initial stages and there has been limited data collected regarding efficacy or safety."
Answered by AI
What is the capacity of participants accepted in this clinical trial?
"Affirmative. Data hosted on clinicaltrials.gov reveals that this medical study is currently recruiting, with initial postings dating back to February 25th 2016 and the most recent update occurring June 1st 2022. 74 individuals are required from 28 different healthcare centres."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger