Temsirolimus as Second-line Therapy in HCC

NCT01567930

Last updated date
Study Location
Boston Baskin Cancer Foundation
Memphis, Tennessee, 38120, United States
Contact
901.226.1493

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Unresectable or Metastatic Hepatocellular Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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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Unresectable or Metastatic Hepatocellular CarcinomaTemsirolimus as Second-line Therapy in HCC
NCT01567930
  1. Memphis, Tennessee
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Temsirolimus as Second-line Therapy in HCC
Official Title  ICMJE A Phase II Study of Temsirolimus as Second-line Therapy in Patients With Advanced, Unresectable Hepatocellular Carcinoma
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Unresectable or Metastatic Hepatocellular Carcinoma
Intervention  ICMJE 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
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 28, 2012)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2013
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

    -

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01567930
Other Study ID Numbers  ICMJE 3066K1-2247
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Tennessee Cancer Institute
Study Sponsor  ICMJE University of Tennessee Cancer Institute
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Jasgit Sachdev, MDUniversity of Tennessee Cancer Institute
PRS Account University of Tennessee Cancer Institute
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP