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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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

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: 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