Phase 2
Completed N=96
A Research Study to Treat Patients With Advanced Hepatocellular Carcinoma
Carcinoma, Hepatocellular
Source: ClinicalTrials.gov NCT00108953 ↗
Enrolled (actual)
96
Serious AEs
41.1%
Results posted
Jun 2009
Primary outcomePrimary: Time to Progression (TTP) — 263; 147 days — p=0.016
Summary
The purpose of this study is to evaluate the safety and efficacy of doxorubicin plus sorafenib versus doxorubicin plus placebo in patients with advanced hepatocellular carcinoma (HCC).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Progression (TTP) |
263; 147 | 0.016 sig |
| SECONDARY Overall Survival |
418; 199 | 0.007 sig |
| SECONDARY Progression Free Survival (PFS) |
242; 85 | 0.018 sig |
| SECONDARY Percentage of Participants in Each Category of Best Tumor Response |
0.0; 2.0; 4.3; 0.0; 66.0; 49.0 | — |
| SECONDARY Time to Symptomatic Progression (TTSP) |
208; 152 | 0.038 sig |
| SECONDARY Duration of Response |
199; 68 | — |
| SECONDARY Time to Response (TTR) |
134; 40 | — |
| SECONDARY Percentage of Participants for Whom Disease Control Was Achieved |
63.8; 30.6 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who have a life expectancy of at least 12 weeks
- Patients with advanced HCC (unresectable, and/or metastatic) which has been histologically or cytologically documented
- Patients must have at least one tumor lesion that meets both of the following criteria:
- can be accurately measured in at least one dimension according to Response Evaluation Criteria in Solid Tumors (RECIST)
- has not been previously treated with local therapy
- Patients who have received local therapy except chemoembolization, such as surgery, radiation therapy, hepatic arterial embolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation are eligible, provided that they either have a target lesion which has not been subjected to local therapy and/or the target lesion(s) within the field of the local therapy has shown an increase of 25% in the size. Local therapy must be completed at least 4 weeks prior to the baseline scan
- Patients who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Exclusion Criteria
- Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted
- History of cardiac disease
- Serious myocardial dysfunction
- Active, clinically serious infections
- Known history of Human Immunodeficiency Virus (HIV) infection
- Known Central Nervous System (CNS) tumors including metastatic brain disease
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
Data sourced from ClinicalTrials.gov (NCT00108953). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.