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Monoclonal Antibodies

Chemotherapy + Bevacizumab + Tumor Treating Fields Therapy for Liver Cancer

Phase 1
Recruiting
Led By Siqing Fu
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Serum creatinine =< 1.5 mg/dL or calculated creatinine clearance >= 50 mL/minutes
An aberrant PI3K pathway such as PIK3CA mutations or PTEN loss, is detected in a CLIA (Clinical Laboratory Improvement Amendments)-certified laboratory
Must not have
Any treatment specific for tumor control within 3 weeks of drugs; or within 2 weeks if cytotoxic agents were given weekly (within 6 weeks for nitrosoureas or mitomycin C), or within 5 half-lives for targeted agents with half-lives and pharmacodynamic effects lasting fewer than 4 days (that includes, but is not limited to, erlotinib, sorafenib, sunitinib, bortezomib, and similar agents), or failure to recover from the toxic effect of any of these therapies prior to study entry
Symptomatic primary tumors or metastasis of brain and/or central nervous system that are uncontrolled with antiepileptics and requiring high doses of steroids
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Summary

This trial is testing a new combination of chemotherapy drugs with bevacizumab, and a new portable device that uses electrical fields to stop the growth of tumor cells, in people with cancer that has come back or does not respond to treatment and has spread to the liver.

Who is the study for?
This trial is for adults with advanced colorectal cancer that has spread to the liver and isn't responding to treatment. They must have a certain level of white blood cells, at least half their tumor in the liver, specific genetic features in their cancer, and measurable disease. Participants need normal organ function and can't be pregnant or breastfeeding. They should not have serious illnesses or conditions that could interfere with the study.
What is being tested?
The trial tests how well a combination of chemotherapy drugs (oxaliplatin, leucovorin, fluorouracil) plus pegylated liposomal doxorubicin hydrochloride and temsirolimus works alongside Bevacizumab (a monoclonal antibody) when used with NovoTTF-100L(P), a device designed to disrupt cancer cell growth using electrical fields.
What are the potential side effects?
Possible side effects include typical chemotherapy reactions like nausea, fatigue, hair loss; Bevacizumab may cause bleeding or blood clots; NovoTTF-100L(P) might lead to skin irritation where it's applied. Each patient's experience can vary based on individual health factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is normal or only slightly reduced.
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My cancer has a specific genetic change related to the PI3K pathway.
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Half of my cancer spread is in my liver.
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My liver enzyme (ALT) levels are within the acceptable range.
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I am able to care for myself and up to being unable to work but can still move around.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had cancer treatment in the last 3 weeks, or within the specific times for certain drugs.
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My brain cancer symptoms are not controlled by medication and need high steroid doses.
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I do not have any severe illnesses that are not under control.
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My heart's electrical activity (QTc) is over 480 milliseconds or I have significant irregular heartbeats.
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I have HIV, hepatitis B, or hepatitis C.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Incidence of adverse events
Secondary study objectives
Biomarker analysis
Response

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B(bevacizumab,liposomal doxorubicin, DAT, NovoTTF-100L[P])Experimental Treatment4 Interventions
Participants receive bevacizumab IV over 90 minutes on days 1 and 15, pegylated liposomal doxorubicin hydrochloride IV over 30 minutes-3 hours on days 1 and 15, and temsirolimus IV over 60-90 minutes on days 1, 8, 15, and 22. Participants also use NovoTTF-100L(P) system over 18 hours daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (FOLFOX6, bevacizumab, NovoTTF-100L[P])Experimental Treatment5 Interventions
Participants receive oxaliplatin, leucovorin, and fluorouracil via pump over 46 hours on beginning on day 1, bevacizumab IV over 30-90 minutes on days 1 and 15, and use NovoTTF-100L(P) system over 18 hours daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5540
Oxaliplatin
2011
Completed Phase 4
~2890
Temsirolimus
2008
Completed Phase 2
~1940
Tumor Treating Fields Therapy
2018
Completed Early Phase 1
~30
Pegylated Liposomal Doxorubicin Hydrochloride
2001
Completed Phase 3
~4520
Fluorouracil
2014
Completed Phase 3
~11700
Leucovorin
2005
Completed Phase 4
~6010

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,649 Total Patients Enrolled
22 Trials studying Liver Cancer
9,411 Patients Enrolled for Liver Cancer
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,948 Total Patients Enrolled
105 Trials studying Liver Cancer
26,544 Patients Enrolled for Liver Cancer
Siqing FuPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
490 Total Patients Enrolled

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03203525 — Phase 1
Liver Cancer Research Study Groups: Arm B(bevacizumab,liposomal doxorubicin, DAT, NovoTTF-100L[P]), Arm A (FOLFOX6, bevacizumab, NovoTTF-100L[P])
Liver Cancer Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT03203525 — Phase 1
Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03203525 — Phase 1
~18 spots leftby Dec 2026
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