Combination Chemotherapy and Bevacizumab With the NovoTTF-100L(P) System in Treating Participants With Advanced, Recurrent, or Refractory Hepatic Metastatic Cancer
NCT ID: NCT03203525
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
52 participants
INTERVENTIONAL
2020-06-23
2026-12-31
Brief Summary
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Detailed Description
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I. To define the maximum tolerated doses (MTD) of two established chemotherapy regimens (Arm A: FOLFOX6 \[oxaliplatin, fluorouracil (5FU) and leucovorin (folinic acid)\] plus bevacizumab; and Arm B: pegylated liposomal doxorubicin hydrochloride \[liposomal doxorubicin\] and bevacizumab plus temsirolimus \[DAT\]) in combination with the concurrent use of the NovoTTF-100L(P) system in patients with predominant hepatic metastases.
II. To define the safety profiles of FOLFOX6 plus bevacizumab or DAT with concurrent NovoTTF-100L(P) in patients with predominant hepatic metastases.
SECONDARY OBJECTIVES:
I. To evaluate clinical response signals to the treatment with FOLFOX6 plus bevacizumab or DAT with concurrent NovoTTF-100L(P).
II. To assess predictive biomarkers by analyzing baseline molecular mutation status, and resistant pathways by comparing molecular signatures at baseline versus at time of relapse in patients who have achieved objective responses.
OUTLINE: This is a dose-escalation study. Participants are assigned to 1 of 2 arms.
ARM A: Participants receive oxaliplatin, leucovorin, and fluorouracil via pump over 46 hours beginning on day 1, bevacizumab intravenously (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.
ARM B: 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.
After the completion of study treatment, patients are followed at 30 days.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A (FOLFOX6, bevacizumab, NovoTTF-100L[P])
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.
Bevacizumab
Given IV
Fluorouracil
Given via pump
Leucovorin
Given via pump
Oxaliplatin
Given via pump
Tumor Treating Fields Therapy
Use NovoTTF-100L(P) system
Arm B(bevacizumab,liposomal doxorubicin, DAT, NovoTTF-100L[P])
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.
Bevacizumab
Given IV
Pegylated Liposomal Doxorubicin Hydrochloride
Given IV
Temsirolimus
Given IV
Tumor Treating Fields Therapy
Use NovoTTF-100L(P) system
Interventions
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Bevacizumab
Given IV
Fluorouracil
Given via pump
Leucovorin
Given via pump
Oxaliplatin
Given via pump
Pegylated Liposomal Doxorubicin Hydrochloride
Given IV
Temsirolimus
Given IV
Tumor Treating Fields Therapy
Use NovoTTF-100L(P) system
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Predominant hepatic metastasis is defined as at least 50% of the total tumor burden involving the liver
* An aberrant PI3K pathway such as PIK3CA mutations or PTEN loss, is detected in a CLIA (Clinical Laboratory Improvement Amendments)-certified laboratory
* For patients who are enrolled into the arm of FOLFOX6 plus bevacizumab, they must have metastatic colorectal cancer with predominant hepatic metastases
* For patients who are enrolled into the arm of DAT, they must have predominant hepatic metastases harboring an aberrant PI3K pathway
* Patients must have measurable or evaluable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Women of child-bearing potential (women who are not postmenopausal for at least one year or are not surgically sterile) and men must agree to use adequate contraception (e.g., hormonal, barrier device, or abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose of the study agents
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Neutrophils \>= 1,500/uL
* Platelets \>= 100,000/uL
* Total bilirubin =\< 1.5 x ULN (upper limit of normal) (except patients with Gilbert's syndrome, who must have a total bilirubin =\< 3.0 mg/dL)
* Alanine aminotransferase (ALT) =\< 3 x ULN or =\< 5 x ULN if liver metastases persist
* Serum creatinine =\< 1.5 mg/dL or calculated creatinine clearance \>= 50 mL/minutes
* Patients should be able to read and fully understand the requirements of the trial, be willing to comply with all trial visits and assessments, and be willing and able to sign an Institutional Reviewed Board (IRB)-approved written informed consent document
* Patients may receive palliative radiation therapy immediately before or during the treatment if the radiation therapy is not delivered to the sole target lesions
Exclusion Criteria
* Patients who have not recovered from major surgical procedure, or significant traumatic injury (i.e., patients still need additional medical care for these issues)
* History of allergic reactions to the study drugs or their analogs, or any component of the products, or sensitive to conductive hydrogels used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes
* 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
* Implanted pacemaker, defibrillator, nerve stimulator or other active electronic medical devices
* Corrected QT interval (QTc) is greater than 480 milliseconds (msec) at screening, or documented clinically significant arrhythmias. The QTc formula Bazett will be used for assessing subject eligibility
* History of stroke or transient ischemic attack, peripheral vascular disease, active gastric or duodenal ulcer, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
* Patients with known human immunodeficiency virus infection, active hepatitis B or C
* Women who are pregnant will be excluded from the study
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Siqing Fu
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Siqing Fu
Role: primary
Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2018-01597
Identifier Type: REGISTRY
Identifier Source: secondary_id
2014-0357
Identifier Type: OTHER
Identifier Source: secondary_id
2014-0357
Identifier Type: -
Identifier Source: org_study_id