Combining chemotherapy and electrical fields to treat liver cancer
A Phase I Study of the NovoTTF-100L(P) System to Enhance Antitumor Activity in Patients With Predominant Hepatic Metastatic Cancer
This study is testing a new treatment for advanced liver cancer that combines chemotherapy, a specific antibody, and electrical fields to see if it helps patients whose cancer has come back or is hard to treat.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | bevacizumab, erlotinib, sunitinib, radiation, chemotherapy, doxorubicin |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03203525 on ClinicalTrials.gov |
What this trial studies
This phase I trial investigates the safety and effectiveness of combining chemotherapy drugs and the monoclonal antibody bevacizumab with the NovoTTF-100L(P) system for patients with advanced liver cancer that has returned or is resistant to treatment. The study aims to determine the maximum tolerated doses of two chemotherapy regimens while assessing their safety profiles. Participants will be assigned to one of two treatment arms, receiving either FOLFOX6 or pegylated liposomal doxorubicin hydrochloride along with bevacizumab and the NovoTTF-100L(P) system. The trial also seeks to evaluate clinical responses and identify predictive biomarkers related to treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients with advanced malignancies, particularly those with predominant hepatic metastases and specific genetic mutations.
Not a fit: Patients with liver cancer that is not predominantly metastatic or those who have not been previously treated may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients with advanced liver cancer that is resistant to standard therapies.
How similar studies have performed: Other studies have shown promise in using similar combination therapies for advanced cancers, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with advanced malignancies, either refractory to standard therapy or for which no effective standard therapy is available, unless the drugs in the protocol are part of the standard of care for a specific diagnosis * 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: * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection 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 study requirements * 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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Siqing Fu — M.D. Anderson Cancer Center
- Study coordinator: Siqing Fu
- Email: siqingfu@mdanderson.org
- Phone: 713-792-4318
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.