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| ID | Type | Description | Link |
|---|---|---|---|
| SCCC-2007101 | |||
| BAYER-SCCC-2007101 |
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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.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive intrahepatic arterial infusion of cisplatin or carboplatin over 30-45 minutes on day 1 and oral sorafenib tosylate twice daily on days 8-35. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cisplatin or Carboplatin + Sorafenib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Experiencing Adverse Events | The number of subjects experiencing adverse events after receiving protocol therapy. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Achieving Clinical Benefit | Number of patients achieving complete or partial response according to RECIST criteria | 36 months |
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DISEASE CHARACTERISTICS:
Histologically confirmed hepatocellular carcinoma (HCC) OR serum alpha fetoprotein ≥ 400 ng/mL with radiological evidence suggestive of HCC
Child-Pugh class A or selected Child-Pugh class B disease (Child-Pugh score ≤ 7 points)
No disease outside the liver or macroscopic invasion of the major vessels such as the portal vein
No known brain metastasis
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 < 5 times upper limit of normal
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
No cardiac disease, including any of the following:
No uncontrolled hypertension, defined as systolic BP > 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:
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| Name | Affiliation | Role |
|---|---|---|
| Lynn G. Feun, MD | University of Miami Sylvester Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cisplatin or Carboplatin + Sorafenib | Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles. Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously. Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cisplatin or Carboplatin + Sorafenib | Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles. Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously. Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Experiencing Adverse Events | The number of subjects experiencing adverse events after receiving protocol therapy. | Of the 11 participants enrolled, 10 had results that were evaluable. | Posted | Number | participants | 36 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cisplatin or Carboplatin + Sorafenib | Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles. Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously. Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Grade 1 Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lynn Feun MD | University of Miami Sylvester Comprehensive Cancer Center | 305-243-4981 | lfeun@med.miami.edu |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Cisplatin | Drug | Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles. |
|
| Sorafenib | Drug | Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously. |
|
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Child-Pugh Score | Child-Pugh score is used to assess the prognosis of chronic liver disease, mainly cirrhosis. Although it was originally used to predict mortality during surgery, it is now used to determine the prognosis, as well as the required strength of treatment and the necessity of liver transplantation. Chronic liver disease is classified into Child-Pugh class A to C: Child-Pugh A: Points (5-6); 1 year survival (100%); 2 year survival (85%) Child-Pugh B: Points (7-9); 1 year survival (81%); 2 year survival (57%) Child-Pugh C: Points (10-15); 1 year survival (45%); 2 year survival (35%) | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Number of Patients Achieving Clinical Benefit | Number of patients achieving complete or partial response according to RECIST criteria | Of the 11 participants enrolled, 10 had results that were evaluable. | Posted | Number | participants | 36 months |
|
|
|
| 0 |
| 10 |
| 2 |
| 10 |
| Esophagheal Bleeding | Gastrointestinal disorders | Patient had prior history of esophageal varices. |
|
| Hemorrhoidal Bleeding | General disorders | Systematic Assessment |
|
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| D008107 |
| Liver Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D017672 |
| Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |