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Colon Cancer Liver MetastasisPhase 2ABLATENCT01464593

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

A Phase 2 study testing Lyso-Thermosensitive Liposomal Doxorubicin, 5% Dextrose Solution and ThermoDox in people with Colon Cancer Liver Metastasis, run by Imunon at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colon Cancer Liver Metastasis
What is being tested?
Lyso-Thermosensitive Liposomal Doxorubicin, 5% Dextrose Solution and ThermoDox
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
4 sitesUnited States
Study dates
Sep 2011to Jun 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Cleveland Clinic Hospital

    Cleveland, Ohio, 44195

  • UCLA

    Los Angeles, California, 90095

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

About this study

Official title: Phase II Open Label Trial of Thermal Ablation and Lyso-Thermosensitive Liposomal Doxorubicin (Thermodox) for Metastatic Colorectal Cancer (mCRC) Liver Lesions

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).

Read the detailed description

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 liver lesions.

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 reactions.

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 assessor.

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.

Being tested
Lyso-Thermosensitive Liposomal Doxorubicin, 5% Dextrose Solution, ThermoDox
Keywords
Colorectal Liver Metastasis, Colon Cancer, Liver Cancer, Liver Metastasis, Liver metastases
Medical subject headings
Colonic Neoplasms, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lyso-Thermosensitive Liposomal DoxorubicinDrug

    Also called Liposomal doxorubicin, Doxorubicin, Thermodox

    Thermally sensitive liposomal doxorubicin 50 mg/m2 single 30 minute intravenous infusion.

  • 5% Dextrose SolutionOther

    Single 30 minute intravenous infusion

  • ThermoDoxDrug

    ThermoDox is a Lyso-thermosensitive Liposomal Doxorubicin designed to be used in conjunction with thermal ablation.

Study groups in NCT01464593
Study groupRoleWhat they receive
ThermodoxExperimentalThermodox 50 mg/m2 intravenous infusion over 30 minutes starting 15 minutes before thermal ablation.
Receives: Drug: Lyso-Thermosensitive Liposomal Doxorubicin; Other: 5% Dextrose Solution; Drug: ThermoDox

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

Secondary outcomes (3)

  1. Evaluation of Safety

    Adverse events will be assessed through 1 month following study treatment(s). AE's after 1 month through the Month 25 assessment are reported if possibly, probably, or definitely related to study drug. Safety data will include physical exams, vital signs, ECGs, Echocardiograms/MUGA Scans, hematology, clinical chemistry and urinalysis.

    Measured: 1 month

  2. Time to Local Recurrence

    Measured as the time to local recurrence after ablation as measured from the date of randomization.

    Measured: 2 years

  3. Overall Survival

    Measured as time from randomization to death or the end of the study at month 37.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionMay 2013
  4. Study completionJun 2013

Why it stopped: trial design contingent on RFA optimization

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01464593
Sponsor's protocol ID
104-10-201
Acronym
ABLATE
Status last verified
Sep 2022
First submitted
1 Nov 2011
Last updated
13 Oct 2022
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lyso-Thermosensitive Liposomal Doxorubicin, 5% Dextrose Solution and ThermoDox in people with Colon Cancer Liver Metastasis, run by Imunon at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the Local Tumor Control at 1 Year Post Randomization (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01464593.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.

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