Phase
Condition
Neoplasm Metastasis
Neoplasms
Treatment
Oxaliplatin
Tumor Treating Fields Therapy
Pegylated Liposomal Doxorubicin Hydrochloride
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with advanced malignancies, either refractory to standard therapy or forwhich no effective standard therapy is available, unless the drugs in the protocolare part of the standard of care for a specific diagnosis
Predominant hepatic metastasis is defined as at least 50% of the total tumorburden involving the liver
An aberrant PI3K pathway such as PIK3CA mutations or PTEN loss, is detected ina CLIA (Clinical Laboratory Improvement Amendments)-certified laboratory
For patients who are enrolled into the arm of FOLFOX6 plus bevacizumab, theymust have metastatic colorectal cancer with predominant hepatic metastases
For patients who are enrolled into the arm of DAT, they must have predominanthepatic metastases harboring an aberrant PI3K pathway
Patients must have measurable or evaluable disease, as defined by ResponseEvaluation Criteria in Solid Tumors (RECIST) 1.1
Women of child-bearing potential (women who are not postmenopausal for at least oneyear 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 theduration of study participation, and for 30 days after the last dose of the studyagents
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance statusof 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'ssyndrome, 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 ableto sign an Institutional Reviewed Board (IRB)-approved written informed consentdocument
Patients may receive palliative radiation therapy immediately before or during thetreatment if the radiation therapy is not delivered to the sole target lesions
Exclusion
Exclusion Criteria:
Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection requiring intravenous antibiotics, symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), unstable angina pectoris,uncontrolled systemic hypertension (systolic blood pressure [BP] > 140 mm Hg,diastolic BP > 90 mm Hg), left ventricular ejection fraction < 50%, active bleeding,or psychiatric illness/social situations that would limit compliance with studyrequirements
Patients who have not recovered from major surgical procedure, or significanttraumatic injury (i.e., patients still need additional medical care for theseissues)
History of allergic reactions to the study drugs or their analogs, or any componentof 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 weeksif cytotoxic agents were given weekly (within 6 weeks for nitrosoureas or mitomycinC), or within 5 half-lives for targeted agents with half-lives and pharmacodynamiceffects lasting fewer than 4 days (that includes, but is not limited to, erlotinib,sorafenib, sunitinib, bortezomib, and similar agents), or failure to recover fromthe toxic effect of any of these therapies prior to study entry
Symptomatic primary tumors or metastasis of brain and/or central nervous system thatare uncontrolled with antiepileptics and requiring high doses of steroids
Implanted pacemaker, defibrillator, nerve stimulator or other active electronicmedical devices
Corrected QT interval (QTc) is greater than 480 milliseconds (msec) at screening, ordocumented clinically significant arrhythmias. The QTc formula Bazett will be usedfor assessing subject eligibility
History of stroke or transient ischemic attack, peripheral vascular disease, activegastric or duodenal ulcer, abdominal fistula, gastrointestinal perforation, orintra-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
Study Design
Study Description
Connect with a study center
M D Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
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