Temsirolimus as Second-line Therapy in HCC

NCT01567930 | Unknown Phase 2 DMC

• 1 other identifier: 3066K1-2247
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Unresectable or Metastatic Hepatocellular Carcinoma

Keywords

Temsirolimus; HCC; Advanced hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

• Safety and tolerability

• Biochemical response

• Pharmacokinetics

• Circulating tumor cells levels

Interventions

Temsirolimus DRUG

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

Also known as: Torisel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Tennessee Cancer Institute: lead
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

Boston Baskin Cancer Foundation

Memphis, Tennessee, 38120, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

temsirolimus

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jasgit Sachdev, MD

  University of Tennessee Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steve West, BS, CCRP

CONTACT

901.226.1493; steve.west@bmhcc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2012
• First Posted: March 30, 2012
• Study Start: February 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: December 17, 2012

Record last verified: 2012-03

Locations

US (1)