Phase 2 Study of Thermodox as Adjuvant Therapy With Thermal Ablation (RFA) in Treatment of Metastatic Colorectal Cancer(mCRC)

Stopped early · Phase 2

Conditions studied: Colon Cancer Liver Metastasis

In brief

The purpose of this study is to determine the safety and efficacy of Thermodox, a thermally sensitive liposomal doxorubicin, in combination with thermal ablation in the treatment of hepatic colorectal liver metastases (CRLM).

Key facts

Study ID

NCT01464593

Run by

Imunon

People needed

2

Starts

2011-09-01

Expected to finish

2013-06-01

Last updated by the study team

2022-10-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologic diagnosis of colorectal cancer.
• A minimum of 1 unresectable mCRC liver lesion at baseline clinically indicated for radiofrequency ablation (RFA) or microwave ablation (MWA).
• Recurrent lesions may have been treated previously by resection or ablation.
• Anticipated ablation volume will be no larger than either removal of 3 hepatic segments or removal of more than 30% of total liver volume (as per maximum surgical limit).
• Patients may have resectable lesions that are treated surgically.
• If additional lesions are discovered during the ablation treatment procedure that were undetectable at screening will be treated at the discretion of the physician and guided by local standard of care.
• Confirm the lesions are malignant by a pretreatment biopsy or by a biopsy obtained during the ablation procedure.
• Subjects with suspected or limited extra-hepatic mCRC are eligible provided thermal ablation is clinically indicated. Chemotherapy is not permitted within 5 half-lives or 30 days if shorter prior to initial study treatment through 30 days following final study treatment.
• Male or female 18 years of age or older.
• Are willing to sign an informed consent form.
• Left Ventricular Ejection Fraction(LVEF) ≥ 50%
• Willing to return to the study site for study visits.
• Have ECOG performance status ≤ 2 and life expectancy of ≥ 6 months.

You may not qualify if…

• Concomitant bowel surgery and/or synchronous colon resection.
• Have serious illnesses including, but not limited to, congestive heart failure;life threatening cardiac arrhythmia; or myocardial infarction or cerebral vascular accident within the last 6 months.
• Have previously received any doxorubicin (study subjects being considered for completion of treatment may have received ThermoDox previously).
• Are pregnant or breast-feeding. In women of childbearing potential, a negative pregnancy test (serum) is required within 14 days prior to study treatment.
• Women and men of childbearing potential who are not practicing an acceptable form of birth control (i.e. diaphragm, cervical cap, condom, surgical sterility or birth control pills.
• Have any known allergic reactions to any of the drugs or liposomal components or intravenous imaging agents to be used in this study.
• Have portal or hepatic vein tumor invasion/thrombosis.
• Have INR > 1.5 times the institution's upper normal limit (UNL), except in subjects who are therapeutically anticoagulated for medical conditions unrelated to CRLM such as atrial fibrillation. Subjects may be re-screened after condition is treated or anticoagulant is withheld.
• Have platelet count < 75,000/mm3, absolute neutrophil count < 1500/mm3, or Hgb < 10.0 g/dL (unless the hemoglobin value has been stable, the subject is cardiovascularly stable, asymptomatic, and judged able to withstand the RFA procedure).
• Have serum creatinine ≥ 2.5 mg/dL or calculated creatinine clearance (CrCl) ≤ 25.0 mL/min.
• Have serum bilirubin > 3.0 mg/dL.
• Have serum albumin < 2.8 g/dL.
• Have body temperature > 38.3°C immediately prior to study treatment.
• Have contraindications to receiving doxorubicin HCl.
• Are being treated with other investigational agents or use of an investigational agent within 5 half-lives or 30 days whichever is longer preceding the first dose of study medication.
• Use of chemotherapy within 5 half-lives or 30 days, whichever is shorter, preceding the first dose of study medication and no chemotherapy planned for 30 days after ablation(s).
• Have concurrent malignancy other than mCRC (subjects wtih treated squamous cell carcinoma of the skin or basal cell carcinoma of the skin maybe included) or ongoing medically significant active infection.
• Documented HIV positive.
• NYHA class III or IV functional classification for heart failure.
• Evidence of hemochromatosis.
• Have history of contrast induced nephropathy and unable to undergo MRI.
• Have a history of Nephrogenic Systemic Fibrosis (NSF).

Where it is running

• UCLA — Los Angeles, California, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Cleveland Clinic Hospital — Cleveland, Ohio, United States
• Rhode Island Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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