A Phase 2 interventional study of sunitinib malate and capecitabine in Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer and Localized Unresectable Adult Primary Liver Cancer, sponsored by University of Washington. Terminated at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2017-06-01.
Sponsored by University of Washington · Phase 2, Interventional, and Treatment
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.
3,249 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.
This study's enrollment of 41 is below the median of 55 across 2,347 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →University of Washington is the lead sponsor of 1,431 studies on the registry; 226 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
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Exclusion Criteria:
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.
Drug: sunitinib malate · Drug: capecitabine
Given PO
Also known as: SU11248, sunitinib, Sutent
Given PO
Also known as: CAPE, Ro 09-1978/000, Xeloda
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.
Time frame: From the start of treatment to time of progression or death from any cause, assessed up to 3 years
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.
Time frame: 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
Time frame: From start of treatment until death from any cause, assessed up to 3 years
Due to the lack of apparent benefit, the study was closed to further enrollment after the 7th patient was enrolled.
| Milestone | Treatment (Sunitinib Malate and Capecitabine) |
|---|---|
| Started | 7 |
| Completed | 0 |
| Not completed | 7 |
| Withdrew: Lack of efficacy | 4 |
| Withdrew: Adverse event | 3 |
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.
| days | Treatment (Sunitinib Malate and Capecitabine) |
|---|---|
| Median Progression-free Survival | 203 (13 to 292) |
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.
| Participants | Treatment (Sunitinib Malate and Capecitabine) |
|---|---|
| Complete Response | 0 |
| Partial Response | 0 |
| Stable Disease | 4 |
Survival estimated by Kaplan-Meier method
| days | Treatment (Sunitinib Malate and Capecitabine) |
|---|---|
| Median Overall Survival | 282 (157 to 400) |
Collected over Day of first administration of study drugs to 30 days after last dose of study drug, up to 3 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Sunitinib Malate and Capecitabine) | 7/7 (100%) | 2/7 (28.6%) | 7/7 (100%) |
| Event | Treatment (Sunitinib Malate and Capecitabine) |
|---|---|
| Extrapyramidal myelinosisNervous system disorders | 1/7 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 1/7 |
| Event | Treatment (Sunitinib Malate and Capecitabine) |
|---|---|
| Hand-foot SyndromeSkin and subcutaneous tissue disorders | 5/7 |
| ThrombocytopeniaBlood and lymphatic system disorders | 3/7 |
| NeutropeniaBlood and lymphatic system disorders | 3/7 |
| NauseaGastrointestinal disorders | 2/7 |
| MucositisGastrointestinal disorders | 2/7 |
| HeadacheNervous system disorders | 1/7 |
| VomitingGastrointestinal disorders | 1/7 |
| AnemiaBlood and lymphatic system disorders | 1/7 |
| HypertensionVascular disorders | 1/7 |
| Oral Herpes Simplex infectionInfections and infestations | 1/7 |
| Age, Continuous(years) | Treatment (Sunitinib Malate and Capecitabine) |
|---|---|
| Median | 57 (28 to 66) |
| Sex: Female, Male(Participants) | Treatment (Sunitinib Malate and Capecitabine) |
|---|---|
| Female | 0 |
| Male | 7 |
| Ethnicity (NIH/OMB)(Participants) | Treatment (Sunitinib Malate and Capecitabine) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 7 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Treatment (Sunitinib Malate and Capecitabine) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 5 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Treatment (Sunitinib Malate and Capecitabine) |
|---|---|
| United States | 7 |
The record gives a start of Sep 2008, a primary completion of Apr 2010 and a completion of Jun 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2017, 7 years 2 months after primary completion.
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This study is terminated, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Sunitinib · Capecitabine