Study of Sorafenib and Infusional 5-Fluorouracil in Advanced Hepatocellular Carcinoma (HCC)

NCT00619541 | Completed Phase 2 DMC

• 1 other identifier: PISADUE
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to use Sorafenib + 5-FU to evaluate activity, efficacy, safety, pharmacodynamics (PD) and pharmacokinetics (PK) in patients with advanced hepatocellular carcinoma (HCC).

Conditions

Hepatocellular Carcinoma

Keywords

HCC; Sorafenib; Pisa; Ricci; 5-FU; 5FU; 5 FU; Advanced HCC

Outcome Measures

Primary Outcomes (1)

• N° of non progressive disease (complete and partial responses, stable disease)

  1 year

Secondary Outcomes (1)

• Toxicity of the combination,ORR,Duration of responses, TTP and OS.PK, PD,Baseline pERK concentration, phospho VEGF-R2 concentration, plasma proteomics and gene expression profiling on blood cells and tumor biopsy

  1 year

Study Arms (1)

A

EXPERIMENTAL

* 5-FU 3000 mg/sqm 48 hours continuous infusion every 14 days * Sorafenib 400 mg bid orally continuously * 5-FU will be administered for a maximum of 12 cycles. * Sorafenib will be administered from the start of treatment in combination with 5-FU until progression of disease.

Drug: Infusional 5-Fluorouracil; Drug: Sorafenib (Bay 43-9006)

Interventions

Infusional 5-Fluorouracil DRUG

5-FU 3000 mg/sqm 48 hours continuous infusion every 14 days. 5-FU will be administered for a maximum of 12 cycles.

A

Sorafenib (Bay 43-9006) DRUG

Sorafenib 400 mg bid orally continuously. Sorafenib will be administered from the start of treatment in combination with 5-FU until progression of disease.

A

Eligibility Criteria

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

You may qualify if:

• Age 18 years.
• Patients should have proven primary HCC according to one of the following criteria:
• Histological evidence of HCC on a biopsy specimen. Patients with the fibrolamellar subset are excluded, as are any patients with a mixed histology.
• Cytological evidence of HCC is acceptable only if tissue cannot be obtained for histological evaluation.
• ECOG Performance Status of 0 or 1
• Life expectancy of at least 12 weeks at the pre-treatment evaluation.
• Inoperable tumor (T2-T4, any N, M0 or M1 as defined by the TNM classification)
• Patient considered by the investigator to be appropriate for systemic therapy.
• Patients with at least one measurable lesion by CT-scan or MRI according to the Recist criteria, performed within 4 weeks prior to start of dosing.
• Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
• Hemoglobin 8.5 g/dl
• Absolute granulocytes 1.5 x 109/L
• Platelet count 60 x 109/L
• Total serum bilirubin 3 mg/dl
• ALT (SGOT) and AST (SGPT) 5 x upper limit of normal

You may not qualify if:

• Patients who meet the following criteria at the time of screening will be excluded; excluded medical conditions:
• Congestive heart failure defined as NYHA class III or IV.
• Serious cardiac arrhythmias.
• Active coronary artery disease or ischemia.
• Active clinically serious infections (\> grade 2 NCI-CTC).
• Known history of HIV infection.
• Known metastatic brain or meningeal tumors.
• History of seizure disorder.
• History of organ allograft.
• Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors \[Ta, Tis \& T1\] or other malignancies curatively treated \> 3 years prior to entry).
• Patients with clinically significant gastrointestinal bleeding within the past month prior to study entry are ineligible.
• Excluded therapies and medications, previous and concomitant:
• Any surgical procedure within 4 weeks prior to start of study drug.
• Autologous bone marrow transplant or stem cell rescue within 4 months of study entry.
• Use of biologic response modifiers, such as G-CSF, within 3 weeks of study entry. G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity, such as febrile neutropenia, when clinically indicated, or at the discretion of the investigator; however, they may not be substituted for a required dose reduction. Chronic Erythropoietin treatment prior to the study entry or during the study is permitted.

Sponsors & Collaborators

• Italian Trial in Medical Oncology: lead

Study Sites (1)

Dipartimento di Oncologia, dei Trapianti e delle Nuove Tecnologie in Medicina ... Indirizzo: via Roma, 55 - 56100 Pisa Tel. 050-2218690 - Fax. 050-2218685

Pisa, Pisa, 56100, Italy

Location

Related Publications (1)

• Petrini I, Lencioni M, Ricasoli M, Iannopollo M, Orlandini C, Oliveri F, Bartolozzi C, Ricci S. Phase II trial of sorafenib in combination with 5-fluorouracil infusion in advanced hepatocellular carcinoma. Cancer Chemother Pharmacol. 2012 Mar;69(3):773-80. doi: 10.1007/s00280-011-1753-2. Epub 2011 Oct 28.

  PMID: 22033636 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib

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

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

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

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: February 21, 2008
• Study Start: January 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: January 1, 2009
• Last Updated: February 26, 2009

Record last verified: 2009-02

Locations

IT (1)