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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-00605 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies how well giving sunitinib malate together with capecitabine works in treating patients with unresectable or metastatic liver cancer. Sunitinib malate 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. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sunitinib malate together with capecitabine may kill more tumor cells
PRIMARY OBJECTIVES:
I. To determine the progression-free survival of patients with unresectable or metastatic hepatocellular carcinoma (HCC) treated with sunitinib and capecitabine.
SECONDARY OBJECTIVES:
I. To determine the overall survival, response rate by Response Evaluation Criteria in Solid Tumors (RESIST) criteria, alpha fetoprotein (AFP) response, survival at one year, and safety and tolerability.
OUTLINE:
Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-21 and capecitabine PO twice daily (BID) on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for up to 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (sunitinib malate and capecitabine) | Experimental | Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sunitinib malate | Drug | Given PO |
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| Measure | Description | Time Frame |
|---|---|---|
| Median Progression-free Survival | Analyzed using the Kaplan-Meier method. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progressive disease (PD) indicates at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | From the start of treatment to time of progression or death from any cause, assessed up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Best Response by RECIST Criteria | Incidence rate of best clinical response (complete response [CR], partial response [PR], stable disease [SD], or progressive disease[PD]) as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR indicates disappearance of all target lesions. PR indicates at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease indicates at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) indicates neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Whiting | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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Due to the lack of apparent benefit, the study was closed to further enrollment after the 7th patient was enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Sunitinib Malate and Capecitabine) | Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity. sunitinib malate: Given PO capecitabine: Given PO |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| capecitabine | Drug | Given PO |
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| From the start of the treatment until disease progression/recurrence, assessed every 3 months, up to 3 years |
| Median Overall Survival | Survival estimated by Kaplan-Meier method | From start of treatment until death from any cause, assessed up to 3 years |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Sunitinib Malate and Capecitabine) | Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity. sunitinib malate: Given PO capecitabine: Given PO |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Median Progression-free Survival | Analyzed using the Kaplan-Meier method. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progressive disease (PD) indicates at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. | Posted | Median | Full Range | days | From the start of treatment to time of progression or death from any cause, assessed up to 3 years |
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| Secondary | Best Response by RECIST Criteria | Incidence rate of best clinical response (complete response [CR], partial response [PR], stable disease [SD], or progressive disease[PD]) as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR indicates disappearance of all target lesions. PR indicates at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease indicates at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) indicates neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. | Only 4 patients in this study had assessments of response by RECIST criteria. | Posted | Count of Participants | Participants | From the start of the treatment until disease progression/recurrence, assessed every 3 months, up to 3 years |
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| Secondary | Median Overall Survival | Survival estimated by Kaplan-Meier method | Posted | Median | Full Range | days | From start of treatment until death from any cause, assessed up to 3 years |
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Day of first administration of study drugs to 30 days after last dose of study drug, up to 3 years.
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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 | Treatment (Sunitinib Malate and Capecitabine) | Patients receive sunitinib malate PO QD on days 1-21 and capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence or disease progression or unacceptable toxicity. sunitinib malate: Given PO capecitabine: Given PO | 7 | 7 | 2 | 7 | 7 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extrapyramidal myelinosis | Nervous system disorders | Non-systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Hand-foot Syndrome | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Mucositis | Gastrointestinal disorders | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Hypertension | Vascular disorders | Non-systematic Assessment |
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| Oral Herpes Simplex infection | Infections and infestations | Non-systematic Assessment |
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| Thickened callus on foot | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Increased alanine amino transferase | Hepatobiliary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Clinical Research Support | Cancer Consortium | 206-667-5767 | lmendels@fredhutch.org |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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| Title | Denominators | Categories | ||||
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