Temsirolimus in Treating Patients With Advanced Liver Cancer and Cirrhosis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Federation Francophone de Cancerologie Digestive
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01079767
First received: March 2, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
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Purpose
RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well temsirolimus works in treating patients with advanced liver cancer and cirrhosis.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cancer |
Drug: temsirolimus Other: laboratory biomarker analysis Other: pharmacological study Procedure: quality-of-life assessment Radiation: fludeoxyglucose F 18 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Primary Purpose: Treatment |
| Official Title: | Advanced Hepatocellular Carcinoma on Child B Cirrhosis: Tolerance and Efficacy of Torisel® (Temsirolimus) |
Resource links provided by NLM:
Genetics Home Reference related topics:
North American Indian childhood cirrhosis
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- 3-month disease-control rate according to RECIST criteria [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 3-month objective response rate according to RECIST criteria [ Designated as safety issue: No ]
- 1-month metabolic response rate on PET/CT scan [ Designated as safety issue: No ]
- Time to progression [ Designated as safety issue: No ]
- Disease-free progression survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
- Clinical and biological tolerance [ Designated as safety issue: No ]
- Rate of m-TOR pathway activation and VEGF level [ Designated as safety issue: No ]
- Pharmacokinetics [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2010 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- To determine the 3-month disease-control rate according to RECIST criteria in patients with advanced hepatocellular carcinoma and Child-Pugh class B cirrhosis.
Secondary
- To determine the 3-month objective response rate according to RECIST criteria in these patients.
- To determine the 1-month metabolic response rate on PET/CT scan in these patients.
- To determine the 1-month perfusion response rate on hepatic perfusion CT scan in these patients.
- To determine the time to progression in patients treated with this drug.
- To determine the progression-free survival of patients treated with this drug.
- To determine the overall survival of patients treated with this drug.
- To assess quality of life according to QLQ-C30 and QLQ-HCC18 questionnaires.
- To determine the clinical and biological tolerance of this drug in these patients.
- To determine the rate of m-TOR pathway activation and VEGF level.
- To evaluate the pharmacokinetics of this drug in select patients.
OUTLINE: This is a multicenter study.
Patients receive temsirolimus IV over 30-60 minutes on day 1. Treatment repeats once a week in the absence of disease progression or unacceptable toxicity. Patients also undergo fludeoxyglucose F 18 (FDG) positron emission tomography/computed tomography (PET/CT) scan and perfusion CT scan of the liver at baseline and periodically during study treatment.
Patients complete quality of life questionnaires (QLC-C30 and QLQ-HCC18) periodically. Some patients undergo blood and tissue sample collection periodically for pharmacological and laboratory studies.
After completion of study therapy, patients are followed for up to 24 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of hepatocellular carcinoma (HCC) according to the European Association for the Study of the Liver (EASL) criteria
- Advanced disease
- Must be morphologically evaluable
- HCC not accessible to other treatment (e.g., surgery, radiofrequency, or chemoembolization) and can not benefit from antiangiogenic therapy
- CLIP score ≤ 3 (except for patients with tumors invading more than 50% of tumor volume)
Child-Pugh cirrhosis score between B7 and B9, meeting the following criteria:
- Diagnosed clinically, biologically (e.g., prothrombin time, platelets, or albumin), endoscopically (signs of portal hypertension) and morphologically (dysmorphic liver on ultrasound or CT scan), or by liver biopsy
- Not a candidate for transplantation and has not received a liver transplant
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 3 months
- Platelet count ≥ 50,000/mm^3
- Neutrophil count ≥ 1,500/mm^3
- Creatinine clearance ≥ 60 mL/min
- GFR ≥ 30 mL/min
- Serum cholesterol ≤ 350 mg/dL
- Triglycerides ≤ 300 mg/dL
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for more than 2 months after completion of study therapy
- No history of other cancer on treatment
- No cardiopulmonary disease impairment, including a history of stable or unstable angina or myocardial infarction
- No active infection except for viral hepatitis
- No HIV positivity
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 2 weeks since prior inhibitors or inducers of P-glycoprotein, CYP3A4, or CYP3A5
- At least 4 weeks since prior surgery, radiotherapy (except radiotherapy to the bone), transarterial chemoembolization, immunotherapy, or other investigational drug for HCC
- At least 6 months since prior chemotherapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01079767
Locations
| France | |
| Centre Hospitalier Universitaire Henri Mondor | Recruiting |
| Creteil, France, 94010 | |
| Contact: Contact Person 33-1-49-812-367 | |
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Investigators
| Principal Investigator: | Thomas Decaens, MD | Centre Hospitalier Universitaire Henri Mondor |
| Principal Investigator: | Christophe Duvoux | Centre Hospitalier Universitaire Henri Mondor |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT01079767 History of Changes |
| Other Study ID Numbers: | CDR0000666229, FFCD-0903, EUDRACT-2009-014443-36, EU-21004 |
| Study First Received: | March 2, 2010 |
| Last Updated: | March 2, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
adult primary hepatocellular carcinoma advanced adult primary liver cancer localized unresectable adult primary liver cancer recurrent adult primary liver cancer |
Additional relevant MeSH terms:
|
Fibrosis Liver Neoplasms Carcinoma, Hepatocellular Pathologic Processes Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Liver Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
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 May 21, 2013