Temsirolimus as Second-line Therapy in HCC

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Tennessee Cancer Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
University of Tennessee Cancer Institute
ClinicalTrials.gov Identifier:
NCT01567930
First received: February 1, 2012
Last updated: December 13, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Unresectable or Metastatic Hepatocellular Carcinoma
Drug: Temsirolimus
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Temsirolimus as Second-line Therapy in Patients With Advanced, Unresectable Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by University of Tennessee Cancer Institute:

Primary Outcome Measures:
  • Disease Progression [ Designated as safety issue: No ]
    The primary outcome measure is to determine the proportion of patients who are progression free at 3 months.


Secondary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]
    Response rate, clinical benefit rate (complete + partial response + stable disease > 12 weeks) and overall survival with temsirolimus

  • Safety and tolerability [ Designated as safety issue: Yes ]
    Number and frequency of adverse events and serious adverse events will be monitored.

  • Biochemical response [ Designated as safety issue: No ]
    Biochemical response (>50% decline in AFP levels from baseline) with temsirolimus

  • Pharmacokinetics [ Designated as safety issue: No ]
    Pharmacokinetics will be assessed: AUC pre-dose, 1, 3, 24,48, 72 and 162 hours post dose.

  • Circulating tumor cells levels [ Designated as safety issue: No ]
    Feasibility and utility of circulating tumor cells in this patient population


Estimated Enrollment: 25
Study Start Date: February 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Temsirolimus
    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
    Other Name: Torisel
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. All patients must have measurable disease per RECIST criteria.
  4. 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.
  5. Patients must have an ECOG performance status of 0 - 2 (see Appendix B).
  6. Patients must be greater than or equal to 18 years of age.
  7. Patients with Child-Pugh class A (score of 5-6) or class B (score of 7-9) are eligible.
  8. 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.
  9. Patients must have adequate bone marrow function as defined by:

    • Leukocytes ≥ 2000 / mm3 or absolute neutrophil count (ANC) ≥ 1000 / mm3
    • Platelet count ≥ 75000 / mm3
  10. 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.
  11. 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.
  12. 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.
  13. Patients must not have a history of other malignancies that are active and require therapy (other than non-melanoma skin cancers).

Exclusion Criteria:

  1. Patients with prior treatment with any mTOR inhibitor are not eligible.
  2. 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.
  3. Patients taking cytochrome P450 enzyme-inducers or inhibitors are not eligible.
  4. Patients with a known history of HIV infection are not eligible.
  5. Patients with uncontrolled hyperlipidemia or hypercholesterolemia are not eligible (fasting serum cholesterol > 350 mg/dL or fasting serum triglycerides > 400 mg/dL).
  6. Patients with a known history or clinical evidence of CNS metastases are not eligible.
  7. Patients who, in the best judgment of the investigator, will not be able to comply with the requirements of the protocol are not eligible.
  8. Patients with Child-Pugh class C liver disease are not eligible.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01567930

Contacts
Contact: Steve West, BS, CCRP 901.226.1493 steve.west@bmhcc.org

Locations
United States, Tennessee
Boston Baskin Cancer Foundation Recruiting
Memphis, Tennessee, United States, 38120
Sponsors and Collaborators
University of Tennessee Cancer Institute
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Jasgit Sachdev, MD University of Tennessee Cancer Institute
  More Information

No publications provided

Responsible Party: University of Tennessee Cancer Institute
ClinicalTrials.gov Identifier: NCT01567930     History of Changes
Other Study ID Numbers: 3066K1‐2247
Study First Received: February 1, 2012
Last Updated: December 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Tennessee Cancer Institute:
Temsirolimus
HCC
Advanced hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 29, 2014