Trial Outcomes & Findings for Sunitinib Malate and Capecitabine in Treating Patients With Unresectable or Metastatic Liver Cancer (NCT NCT00787787)

Last Updated: 2017-06-01

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

41 participants

Primary outcome timeframe

From the start of treatment to time of progression or death from any cause, assessed up to 3 years

Results posted on

2017-06-01

Participant Flow

Due to the lack of apparent benefit, the study was closed to further enrollment after the 7th patient was enrolled.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	7
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Lack of Efficacy	4
Overall Study Adverse Event	3

Baseline Characteristics

Sunitinib Malate and Capecitabine in Treating Patients With Unresectable or Metastatic Liver Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Sunitinib Malate and Capecitabine) n=7 Participants 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
Age, Continuous	57 years n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	7 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	5 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	7 participants n=93 Participants

PRIMARY outcome

Timeframe: From the start of treatment to time of progression or death from any cause, assessed up to 3 years

Outcome measures

Outcome measures
Measure	Treatment (Sunitinib Malate and Capecitabine) n=7 Participants 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
Median Progression-free Survival	203 days Interval 13.0 to 292.0

SECONDARY outcome

Timeframe: From the start of the treatment until disease progression/recurrence, assessed every 3 months, up to 3 years

Population: Only 4 patients in this study had assessments of 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.

Outcome measures

Outcome measures
Measure	Treatment (Sunitinib Malate and Capecitabine) n=4 Participants 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
Best Response by RECIST Criteria Complete Response	0 Participants
Best Response by RECIST Criteria Stable Disease	4 Participants
Best Response by RECIST Criteria Partial Response	0 Participants

SECONDARY outcome

Timeframe: From start of treatment until death from any cause, assessed up to 3 years

Survival estimated by Kaplan-Meier method

Outcome measures

Outcome measures
Measure	Treatment (Sunitinib Malate and Capecitabine) n=7 Participants 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
Median Overall Survival	282 days Interval 157.0 to 400.0

Adverse Events

Treatment (Sunitinib Malate and Capecitabine)

Serious events: 2 serious events

Other events: 7 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Sunitinib Malate and Capecitabine) n=7 participants at risk 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
Nervous system disorders Extrapyramidal myelinosis	14.3% 1/7 • Number of events 1 • Day of first administration of study drugs to 30 days after last dose of study drug, up to 3 years.
Respiratory, thoracic and mediastinal disorders Pleural effusion	14.3% 1/7 • Number of events 1 • Day of first administration of study drugs to 30 days after last dose of study drug, up to 3 years.

Other adverse events

Other adverse events
Measure	Treatment (Sunitinib Malate and Capecitabine) n=7 participants at risk 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
Nervous system disorders Headache	14.3% 1/7 • Number of events 1 • Day of first administration of study drugs to 30 days after last dose of study drug, up to 3 years.
Gastrointestinal disorders Nausea	28.6% 2/7 • Number of events 2 • Day of first administration of study drugs to 30 days after last dose of study drug, up to 3 years.
Gastrointestinal disorders Vomiting	14.3% 1/7 • Number of events 1 • Day of first administration of study drugs to 30 days after last dose of study drug, up to 3 years.
Skin and subcutaneous tissue disorders Hand-foot Syndrome	71.4% 5/7 • Number of events 11 • Day of first administration of study drugs to 30 days after last dose of study drug, up to 3 years.
Gastrointestinal disorders Mucositis	28.6% 2/7 • Number of events 2 • Day of first administration of study drugs to 30 days after last dose of study drug, up to 3 years.
Blood and lymphatic system disorders Thrombocytopenia	42.9% 3/7 • Number of events 6 • Day of first administration of study drugs to 30 days after last dose of study drug, up to 3 years.
Blood and lymphatic system disorders Anemia	14.3% 1/7 • Number of events 4 • Day of first administration of study drugs to 30 days after last dose of study drug, up to 3 years.
Blood and lymphatic system disorders Neutropenia	42.9% 3/7 • Number of events 10 • Day of first administration of study drugs to 30 days after last dose of study drug, up to 3 years.
Vascular disorders Hypertension	14.3% 1/7 • Number of events 1 • Day of first administration of study drugs to 30 days after last dose of study drug, up to 3 years.
Infections and infestations Oral Herpes Simplex infection	14.3% 1/7 • Number of events 1 • Day of first administration of study drugs to 30 days after last dose of study drug, up to 3 years.
Skin and subcutaneous tissue disorders Thickened callus on foot	14.3% 1/7 • Number of events 1 • Day of first administration of study drugs to 30 days after last dose of study drug, up to 3 years.
General disorders Fatigue	14.3% 1/7 • Number of events 1 • Day of first administration of study drugs to 30 days after last dose of study drug, up to 3 years.
Hepatobiliary disorders Increased alanine amino transferase	14.3% 1/7 • Number of events 1 • Day of first administration of study drugs to 30 days after last dose of study drug, up to 3 years.

Additional Information

Medical Director, Clinical Research Support

Cancer Consortium

Phone: 206-667-5767

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place