Study of Pegylated Liposomal Doxorubicin and Temsirolimus in Patients With Advanced Hepatocellular Cancer

NCT01281943 | Withdrawn Phase 2

• 1 other identifier: 201104170
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This Phase II study will use the MTD from a previous Phase I study at the recommended dose for the combination regimen from the Phase I trial, Doxil 25mg/m2 IV Q 4 weeks and temsirolimus 25mg IV Q week.

Conditions

Liver Neoplasms

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  To determine whether the progression free survival (PFS) rate in patients with advanced HCC using this combination regimen of pegylated liposomal doxorubicin and temsirolimus exceeds 5 months in the majority of treated patients, justifying the further development of this therapeutic regimen in this patient population.

  15 months

Secondary Outcomes (5)

• Toxicity and tolerability for this combination regimen

  3 months

• Disease control rate, objective response rate, and overall survival.

  15 months

• mTOR inhibition

  3 days

• Pharmacogenomics

  1 day

• Polymoprhism assessment

  1 day

Study Arms (1)

Temsirolimus and Pegylated Liposomal Doxorubicin

EXPERIMENTAL

Temsirolimus 25mg andPegylated liposomal doxorubicin 25mg/m2

Drug: Temsirolimus 25mg and Pegylated liposomal doxorubicin 25mg/m2

Interventions

Temsirolimus 25mg and Pegylated liposomal doxorubicin 25mg/m2 DRUG

Temsirolimus 25mg IV on days 1, 8, 15 and 22 of each 28 day cycle Pegylated liposomal doxorubicin 25mg/m2 IV on day 1 of each 28 day cycle

Also known as: (Torisel®), (Doxil®)

Temsirolimus and Pegylated Liposomal Doxorubicin

Eligibility Criteria

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

You may qualify if:

• Histologic Diagnosis: Patients must have a histologically or cytologically proven hepatocellular cancer (HCC) that is not amenable to treatment via resection or liver transplantation. In the absence of a tissue diagnosis, nodules on CT with a characteristic appearance of HCC plus Alpha Fetoprotein (AFP) \> 400ng/ml will be considered diagnostic of HCC.
• Measurable Disease: Patients must have measurable disease.
• Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥20 mm with conventional techniques (PET, CT, MRI, x-ray) or as ≥10 mm with spiral CT scan. All tumor measurements must be recorded in millimeters (or decimal fractions of centimeters).
• A positive bone scan, osteoblastic metastases, and pleural or peritoneal effusions are not considered measurable. Patients with only these lesions are not eligible for entry to the study.
• Prior Therapy: Patients may or may not have received prior systemic therapy in the metastatic setting. No prior treatment with an mTOR inhibitor or with doxorubicin is permitted. Participants must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. No chemotherapy or radiotherapy may be given within 4 weeks prior to the start of protocol treatment.
• Age: Patients must be ≥18 years old. Because no dosing or toxicity data are currently available on the use of temsirolimus in combination with pegylated liposomal doxorubicin in patients \<18 years of age, children are excluded from this study.
• Performance Status: ECOG 0-2 at study entry.
• Life Expectancy: Patients must have a life expectancy of greater than 12 weeks.
• Required Laboratory Values:
• absolute neutrophil count ≥1,500/mm3
• platelets ≥100,000/mm3
• hemoglobin ≥9.0 g/dL
• total bilirubin ≤1.5 x ULN
• AST(SGOT)/ALT(SGPT) ≤1.5 x ULN (≤2.5 x ULN for patients with liver metastases)
• alkaline phosphatase ≤2.5 x ULN

Sponsors & Collaborators

• Washington University School of Medicine: lead

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Liver Neoplasms

Interventions

temsirolimus; liposomal doxorubicin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• A. Craig Lockhart, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 20, 2011
• First Posted: January 24, 2011
• Study Start: June 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: May 1, 2014
• Last Updated: July 4, 2013

Record last verified: 2013-07