Phase 2
N=11
Cisplatin or Carboplatin and Sorafenib in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
Liver Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00875615 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcome: Primary: Number of Subjects Experiencing Adverse Events — 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Carboplatin (Drug); Cisplatin (Drug); Sorafenib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Experiencing Adverse Events |
2 | — |
| SECONDARY Number of Patients Achieving Clinical Benefit |
6 | — |
Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Infusing chemotherapy directly into the liver and giving it together with sorafenib may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of infusing cisplatin or carboplatin directly into the liver and giving it together with sorafenib in treating patients with liver cancer that cannot be removed by surgery.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed hepatocellular carcinoma (HCC) OR serum alpha fetoprotein ≥ 400 ng/mL with radiological evidence suggestive of HCC
- Unresectable disease
- Child-Pugh class A or selected Child-Pugh class B disease (Child-Pugh score ≤ 7 points)
- No Child-Pugh class C disease
- No disease outside the liver or macroscopic invasion of the major vessels such as the portal vein
- No known brain metastasis
- Patients with neurological symptoms must undergo CT scan or MRI of the brain
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- WBC ≥ 3, 000/mm³ (for patients scheduled to receive carboplatin) or ≥ 2,000/mm³ (for patients scheduled to receive cisplatin)
- Platelet count ≥ 100, 000/mm³ (for patients scheduled to receive carboplatin) or ≥ 60,000/mm³ (for patients scheduled to receive cisplatin)
- Serum creatinine ≤ 1.9 mg/dL (for patients scheduled to receive carboplatin) or ≤ 1.5 mg/dL (for patients scheduled to receive cisplatin)
- Serum total bilirubin ≤ 3 mg/dL
- AST and ALT 150 mm Hg or diastolic BP > 90 mm Hg, despite optimal medical management
- No thrombolic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months
- No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 within the past 4 weeks
- No other hemorrhage/bleeding event ≥ CTCAE grade 3 within the past 4 weeks
- No evidence or history of bleeding diathesis or coagulopathy
- No evidence of encephalopathy
- No condition that would impair the ability to swallow whole pills
- No history of malabsorption problems
- No significant traumatic injury within the past 4 weeks
- No serious non-healing wound, ulcer, or bone fracture
- No active clinically serious infection
- No known HIV infection
- No known or suspected allergy to sorafenib tosylate or any other study agent
PRIOR CONCURRENT THERAPY:
- No prior cisplatin, carboplatin, or sorafenib tosylate
- No prior systemic chemotherapy for HCC
- No other prior systemic or locoregional therapy
- More than 4 weeks since prior major surgery or open biopsy
- No concurrent St. John's wort or rifampin
Data sourced from ClinicalTrials.gov (NCT00875615). 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.