Unresectable or Metastatic Hepatocellular CarcinomaPhase 2NCT01567930
Temsirolimus as Second-line Therapy in HCC
A Phase 2 study testing Temsirolimus in people with Unresectable or Metastatic Hepatocellular Carcinoma, run by University of Tennessee Cancer Institute at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the activity of temsirolimus in patients who have advanced hepatocellular carcinoma (HCC) and have been treated with one previous chemotherapy or biologic therapy like sorafenib, but have experienced disease progression or intolerance to that therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable or Metastatic Hepatocellular Carcinoma
- What is being tested?
- Temsirolimus
- Type of treatment
- Injection or infusion
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Mar 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Patients must have advanced unresectable or metastatic hepatocellular carcinoma (HCC). Prior diagnosis of HCC could have been established histologically or based on one of the following criteria:
- Liver mass > 2cm: Characteristic enhancement on at least one imaging technique(triphasic CT scan, MRI, or contrast enhanced ultrasound) or AFP > 200 ng/ml.
- Liver mass between 1 and 2 cm: Characteristic enhancement on two imaging techniques.Diagnosis of HCC must have been confirmed by biopsy if non-characteristic enhancement on imaging.
- All patients must have received exactly one prior systemic therapy (cytotoxic chemotherapy or targeted therapies) and must not be eligible for further locoregional treatment modalities.
- All patients must have measurable disease per RECIST criteria.
- Patients with previous locoregional therapies, including but not limited to radio-frequency ablation, cryoablation, percutaneous ethanol injection, chemo-embolization, hepatic artery embolization, and hepatic artery infused FUDR, stereotactic radiotherapy are eligible provided they have documented progression of their disease or have measurable extrahepatic disease.
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- Patients must have an ECOG performance status of 0 - 2 (see Appendix B).
- Patients must be greater than or equal to 18 years of age.
- Patients with Child-Pugh class A (score of 5-6) or class B (score of 7-9) are eligible.
- Patients must have adequate organ function as defined by:
- AST, ALT and Alkaline phosphatase ≤ 5x upper limit of normal (ULN)
- Total Bilirubin < 2 mg/dl.
- Creatinine clearance ≥ 15ml/min \& patients must not be dialysis dependent.
- Patients must have adequate bone marrow function as defined by:
- Leukocytes ≥ 2000 / mm3 or absolute neutrophil count (ANC) ≥ 1000 / mm3
- Platelet count ≥ 75000 / mm3
- Pregnant and nursing women will be excluded from this study. All patients of reproductive potential must agree to use adequate birth control measures to be eligible for study enrollment.
- Prior palliative radiotherapy is permissible provided it has been completed at least 2 weeks prior to study entry and the patient has recovered from any radiation-related side effects.
- Patients must not be receiving any other investigational agents or other anti-cancer therapies. At least 28 days must have elapsed since completion of previous systemic therapy prior to study entry and the patient should have recovered from all toxicities related to prior therapy.
- Patients must not have a history of other malignancies that are active and require therapy (other than non-melanoma skin cancers).
Who cannot join
- Patients with prior treatment with any mTOR inhibitor are not eligible.
- Patients with a history of an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris,cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements are not eligible.
- Patients taking cytochrome P450 enzyme-inducers or inhibitors are not eligible.
- Patients with a known history of HIV infection are not eligible.
- Patients with uncontrolled hyperlipidemia or hypercholesterolemia are not eligible (fasting serum cholesterol > 350 mg/dL or fasting serum triglycerides > 400 mg/dL).
- Patients with a known history or clinical evidence of CNS metastases are not eligible.
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- Patients who, in the best judgment of the investigator, will not be able to comply with the requirements of the protocol are not eligible.
- Patients with Child-Pugh class C liver disease are not eligible.
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Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Boston Baskin Cancer Foundation
Memphis, Tennessee, 38120
About this study
Official title: A Phase II Study of Temsirolimus as Second-line Therapy in Patients With Advanced, Unresectable Hepatocellular Carcinoma
The purpose of this study is to evaluate the activity of temsirolimus in patients who have advanced hepatocellular carcinoma (HCC) and have been treated with one previous chemotherapy or biologic therapy like sorafenib, but have experienced disease progression or intolerance to that therapy.
Read the detailed description
Currently, no standard therapy exists for patients who progress on sorafenib. mTOR signaling is often up-regulated in HCC promoting cell growth and survival. This process is inhibited by rapamycin, a specific inhibitor of mTOR. Temsirolimus, a rapamycin analog, may delay tumor progression by inhibiting mTOR in HCC.Intervention: Temsirolimus IV
Eligible patients will receive temsirolimus IV on days 1,8,15 every 21 days. Treatment will continue till disease progression or untolerable side effects
- Being tested
- Temsirolimus
- Keywords
- Temsirolimus, HCC, Advanced hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemsirolimusDrug
Also called Torisel
Intervention: Temsirolimus IV Eligible patients will receive temsirolimus IV on days 1,8,15 every 21 days. Treatment will continue till disease progression or untolerable side effects
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Progression
The primary outcome measure is to determine the proportion of patients who are progression free at 3 months.
Secondary outcomes (5)
Response rate
Response rate, clinical benefit rate (complete + partial response + stable disease > 12 weeks) and overall survival with temsirolimus
Safety and tolerability
Number and frequency of adverse events and serious adverse events will be monitored.
Biochemical response
Biochemical response (>50% decline in AFP levels from baseline) with temsirolimus
Pharmacokinetics
Pharmacokinetics will be assessed: AUC pre-dose, 1, 3, 24,48, 72 and 162 hours post dose.
Circulating tumor cells levels
Feasibility and utility of circulating tumor cells in this patient population
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startFeb 2010
- Primary completionDec 2012 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable or Metastatic Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Responsible party
- Sponsor
- Investigators
- Jasgit Sachdev, MD, Principal investigator, University of Tennessee Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567930
- Sponsor's protocol ID
- 3066K1-2247
- Status last verified
- Mar 2012
- First submitted
- 1 Feb 2012
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Temsirolimus as Second-line Therapy in Patients With Advanced, Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01567930
- Acronym / sponsor ID
- 3066K1-2247
- Keywords
- Temsirolimus, HCC, Advanced hepatocellular carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of Tennessee Cancer InstituteUniversity, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Feb 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 30 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the activity of temsirolimus in patients who have advanced hepatocellular carcinoma (HCC) and have been treated with one previous chemotherapy or biologic therapy like sorafenib, but have experienced disease progression or intolerance to that therapy.
Detailed description
Currently, no standard therapy exists for patients who progress on sorafenib. mTOR signaling is often up-regulated in HCC promoting cell growth and survival. This process is inhibited by rapamycin, a specific inhibitor of mTOR. Temsirolimus, a rapamycin analog, may delay tumor progression by inhibiting mTOR in HCC.Intervention: Temsirolimus IV
Eligible patients will receive temsirolimus IV on days 1,8,15 every 21 days. Treatment will continue till disease progression or untolerable side effects
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patients must have advanced unresectable or metastatic hepatocellular carcinoma (HCC). Prior diagnosis of HCC could have been established histologically or based on one of the following criteria:
- All patients must have received exactly one prior systemic therapy (cytotoxic chemotherapy or targeted therapies) and must not be eligible for further locoregional treatment modalities.
- All patients must have measurable disease per RECIST criteria.
- Patients with previous locoregional therapies, including but not limited to radio-frequency ablation, cryoablation, percutaneous ethanol injection, chemo-embolization, hepatic artery embolization, and hepatic artery infused FUDR, stereotactic radiotherapy are eligible provided they have documented progression of their disease or have measurable extrahepatic disease.
- Patients must have an ECOG performance status of 0 - 2 (see Appendix B).
Key exclusion criteria (9 listed)
- Patients with prior treatment with any mTOR inhibitor are not eligible.
- Patients with a history of an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris,cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements are not eligible.
- Patients taking cytochrome P450 enzyme-inducers or inhibitors are not eligible.
- Patients with a known history of HIV infection are not eligible.
- Patients with uncontrolled hyperlipidemia or hypercholesterolemia are not eligible (fasting serum cholesterol > 350 mg/dL or fasting serum triglycerides > 400 mg/dL).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TemsirolimusAlso: ToriselIntervention: Temsirolimus IV Eligible patients will receive temsirolimus IV on days 1,8,15 every 21 days. Treatment will continue till disease progression or untolerable side effects | Drug | – |
Primary outcome
Disease Progression
The primary outcome measure is to determine the proportion of patients who are progression free at 3 months.
5 secondary outcomes
Response rate
Safety and tolerability
Biochemical response
Pharmacokinetics
Circulating tumor cells levels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jasgit Sachdev, MD principal investigator
University of Tennessee Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Temsirolimus in people with Unresectable or Metastatic Hepatocellular Carcinoma, run by University of Tennessee Cancer Institute at 1 site 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 20 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steve West, BS, CCRP (901.226.1493, steve.west@bmhcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Progression. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2012.