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Alkylating agent
Pevonedistat + Chemotherapy for Bile Duct Cancer
Phase 2
Waitlist Available
Led By Dustin A Deming
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Known HIV positive patients who meet the following criteria will be considered eligible: CD4 count >= 350 cells/mm^3, Undetectable viral load, Maintained on modern therapeutic regimens utilizing non-CYP interactive agents (i.e. excluding ritonavir), No history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections
Patient must have histologically confirmed intrahepatic cholangiocarcinoma or biphasic hepatocellular carcinoma and cholangiocarcinoma that is metastatic or unresectable and who have progressed on or been intolerant of one prior line of systemic gemcitabine containing chemotherapy regimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial studies if a drug & chemo combo can shrink bile duct cancer of the liver. The drug blocks enzymes needed for cell growth & chemo kills/stops cell growth/spreading.
Who is the study for?
Adults with advanced bile duct cancer of the liver, who have tried one chemotherapy regimen without success, can join this trial. They should be in good physical condition (ECOG 0-1), expect to live at least 12 weeks, and have measurable disease. Those with HIV or hepatitis must meet specific criteria. People cannot participate if they're planning surgery soon, are pregnant or breastfeeding, haven't recovered from previous treatments' side effects (except hair loss), or have certain heart conditions.Check my eligibility
What is being tested?
The trial is testing Pevonedistat alone and combined with chemotherapy drugs Paclitaxel and Carboplatin for treating liver bile duct cancer. The goal is to see how well these treatments shrink the cancer compared to current methods.See study design
What are the potential side effects?
Pevonedistat may cause cell growth inhibition side effects; Paclitaxel and Carboplatin could lead to typical chemo side effects like nausea, fatigue, low blood counts leading to infection risk, nerve damage causing numbness or pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am HIV positive with a CD4 count >= 350, undetectable viral load, on modern HIV meds without ritonavir, and no AIDS-defining infections.
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I have a specific liver cancer that has spread or can't be removed and didn't respond well to my first chemotherapy.
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I do not have serious heart or lung conditions.
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I have previously received platinum or taxane chemotherapy.
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I am being treated for HCV and my viral load is undetectable.
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I am 18 years old or older.
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I had hepatitis C but have been treated and cured.
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My kidney function tests are within normal limits or my GFR is 40 or above.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My hepatitis B virus load is undetectable with treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate
Secondary outcome measures
Clinical benefit rate
Disease control rate
Incidence of adverse events
+2 moreOther outcome measures
Mutation profile of cholangiocarcinomas with overexpression of the neddylation pathway
Overexpression of NEDD8, NAE1, and UBC12
Specimen banking
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B (pevonedistat, paclitaxel, carboplatin)Experimental Treatment3 Interventions
Patients receive pevonedistat IV over 1 hour on days 1, 3, and 5, paclitaxel IV over 3 hours on day 1, and carboplatin IV over 15-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Starting cycle 5, patients may receive pevonedistat monotherapy at the discretion of treating physician.
Group II: Arm A (pevonedistat)Experimental Treatment1 Intervention
Patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Paclitaxel
2011
Completed Phase 4
~5380
Pevonedistat
2021
Completed Phase 2
~290
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,687 Previous Clinical Trials
40,930,319 Total Patients Enrolled
44 Trials studying Hepatocellular Carcinoma
6,310 Patients Enrolled for Hepatocellular Carcinoma
Dustin A DemingPrincipal InvestigatorECOG-ACRIN Cancer Research Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery in the last 14 days.I am taking medication that affects liver enzymes.I will not donate sperm during or within 4 months after the study.I have not had radiation on more than 25% of my bone marrow.I do not have any severe or uncontrolled infections.I have never been treated with pevonedistat.I have someone legally authorized to make decisions for me due to my impaired decision-making capacity.I am HIV positive with a CD4 count >= 350, undetectable viral load, on modern HIV meds without ritonavir, and no AIDS-defining infections.I haven't had severe diarrhea for more than 3 days in the last 14 weeks.I am using or willing to use effective birth control or abstain from sex during and for 4 months after the study.I have not had immunotherapy in the last 8 weeks.I have a specific liver cancer that has spread or can't be removed and didn't respond well to my first chemotherapy.My cancer has not spread to my brain or spinal cord.I have had immunotherapy or targeted therapies without chemotherapy for my condition.I do not have serious heart or lung conditions.I do not have any uncontrolled illnesses.I have recovered from side effects of previous cancer treatments, except for hair loss.I haven't taken any strong enzyme inducers in the last 14 days.I am not taking any strong medication for metabolism during the study.I do not have any uncontrolled bleeding disorders.I have previously received platinum or taxane chemotherapy.I have a history of heart issues or have been treated with heart-toxic drugs.I have a type of irregular heartbeat that's been managed well for at least 6 months.I am being treated for HCV and my viral load is undetectable.I am 18 years old or older.I do not have any surgeries planned during the study period.I've had localized therapy for my cancer, but it has either spread or gotten worse since then.I had hepatitis C but have been treated and cured.I will not donate eggs during or within 4 months after the study.I haven't had chemotherapy or radiotherapy in the last 2 weeks.I am a woman who could potentially become pregnant.I am not taking any strong medication for epilepsy, infections, or using St. John's wort.I have no allergies to pevonedistat, carboplatin, or paclitaxel.I do not have moderate COPD, interstitial lung disease, or pulmonary fibrosis.My kidney function tests are within normal limits or my GFR is 40 or above.I am fully active or restricted in physically strenuous activity but can do light work.I am HIV-positive, on treatment, and my viral load is undetectable.I have another cancer type, but it won't affect this trial's treatment.My hepatitis B virus load is undetectable with treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (pevonedistat, paclitaxel, carboplatin)
- Group 2: Arm A (pevonedistat)
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 is the current eligibility status of this research project?
"Contrary to expectations, clinicaltrials.gov states that this trial is not presently enrolling participants. This particular study was posted on January 31st 2020 and its last update occured on March 23rd 2023. However, 3875 other trials around the world are actively searching for patients at this time."
Answered by AI
In what geographic areas is this trial currently being conducted?
"As well as the previously mentioned sites, this trial is also enrolling patients at Jewish Hospital in Louisville, Kentucky, Monticello Cancer Center in Monticello, Minnesota and University of Kansas Cancer Centre - Lee's Summit in Lee's Summit, Missouri (amongst other 446 locations)."
Answered by AI
Are there any other examinations that have examined the efficacy of a combination of pevonedistat, paclitaxel, and carboplatin?
"Pevonedistat, paclitaxel and carboplatin (Arm B) was initially researched at the Cancer Center and Beckman Research Institute of Hope in 1999. Since then 1607 clinical trials have been fulfilled with 1100 additional studies still ongoing; many of these are based in Louisville, Kentucky."
Answered by AI
How impactful can the side effects of Arm B (pevonedistat, paclitaxel, carboplatin) be for individuals?
"Thus far, studies have indicated that Arm B (pevonedistat, paclitaxel and carboplatin) is moderately safe. As this is a Phase 2 trial, there are no data to support its efficacy but some evidence of safety; therefore Power assigned it a score of 2 on our scale."
Answered by AI
What is the total enrollment for this clinical trial?
"Unfortunately, this particular study is no longer enrolling participants. It was posted on January 31st 2020 and last updated March 23rd 2023. Currently, 2775 studies are actively admitting patients with hepatocellular carcinoma and 1100 trials for Arm B (pevonedistat, paclitaxel, carboplatin) remain open to interested volunteers."
Answered by AI
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