Phase II Open Label Trial of Thermal Ablation and Lyso-Thermosensitive Liposomal Doxorubicin (Thermodox) for Metastatic Colorectal Cancer (mCRC) Liver Lesions
This is an open label phase II trial to evaluate the safety, feasibility, and efficacy of
ThermoDox in combination wtih thermal ablation for the regional hepatic treatment of mCRC
Eligible colorectal cancer patients will unresectable liver metastases and be candidate for
either radiofrequency ablation (RFA) or microwave ablation (MWA). All unresectable lesions
must be targeted for ablation in in nor more than 2 thermal ablation/ThermoDox procedures.
Approximately 24 hours prior to treatment with ThermoDox, patients will start a regimen of
prophylaxis (detailed in the Study Drug section below) against immediate hypersensitivity
Treatment will begin with a 50 mg/m2 ThermoDox infusion administered intravenously (IV) over
30 minutes. Thermal Ablation will be initiated a minimum of 15 minutes after start of the
infusion and should be completed no later than 3 hours after starting the infusion. Subjects
will have follow up visits on Day 14 and at months 1, 4, 7, 10,13, 16, 19, 22, and 25 (+ 7
days) or until study discontinuation.
At baseline and at each post-treatment clinic visit, patients will self-report their
"quality of life" (QoL) using the 8-item FACT-Hepatobiliary Symptom Index (FHSI-8).
Contrast CT imaging studies or Magnetic Resonance Imaging (MRI)will be used to assess the
effectiveness of therapy. CT or MRI scans will be obtained at baseline and at months 1, 4,
7, 10, 13, 16, 19, 22, and 25(+ 7 days)until local recurrence is seen, the subject has
discontinued, or 2 years of follow-up have elapsed, whichever occurs first. All
protocol-specified CT/MRI images will be centrally read by an independent radiology
Subjects will be followed for each efficacy endpoint local tumor control through 2 years
after treatment. Secondary endpoints including Overall Survival, Time to Local Recurrence,
PRO deterioration) will be evaluated until the event occurs, the subject is discontinued, or
until 3 years following treatment.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the local tumor control at 1 year post randomization
Subject's treated with thermal ablation in conjunction with Thermodox to evaluate local tumor control defined as complete ablation and does not experience recurrence within 1 cm of the ablation site.
Nicholas Borys, M.D.
United States: Food and Drug Administration
|Rhode Island Hospital||Providence, Rhode Island 02903|
|Montefiore Medical Center||Bronx, New York 10467-2490|
|UCLA||Los Angeles, California 90095|
|Cleveland Clinic Hospital||Cleveland, Ohio 44195|