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A Study of Oxaliplatin and Capecitabine in Unresectable Metastatic Hepatocellular Cancer

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ClinicalTrials.gov Identifier: NCT03026803
Recruitment Status : Terminated (Due to Sorafenib became first line treatment for HCC, the designed treatment became less competitive. The company Sanofi decided not to continue to support)
First Posted : January 20, 2017
Results First Posted : March 10, 2017
Last Update Posted : April 13, 2017
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
City of Hope Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Liver Cancer
Hepatocellular Cancer
Interventions Drug: Oxaliplatin
Drug: Capecitabine
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oxaliplatin and Capecitabine
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21 day cycle with Oxaliplatin 50mg/m^2 day 1 and day 8 administered IV, Capecitabine 750 mg/m^2 bid p.o. daily from day 1 to day 14

Oxaliplatin: Given IV

Capecitabine: Given PO

Period Title: Overall Study
Started 4
Completed 4
Not Completed 0
Arm/Group Title Oxaliplatin and Capecitabine
Hide Arm/Group Description

21 day cycle with Oxaliplatin 50mg/m^2 day 1 and day 8 administered IV, Capecitabine 750 mg/m^2 bid p.o. daily from day 1 to day 14

Oxaliplatin: Given IV

Capecitabine: Given PO

Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants
71
(65 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
0
   0.0%
Male
4
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title Response Rate
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxaliplatin and Capecitabine
Hide Arm/Group Description:

21 day cycle with Oxaliplatin 50mg/m^2 day 1 and day 8 administered IV, Capecitabine 750 mg/m^2 bid p.o. daily from day 1 to day 14

Oxaliplatin: Given IV

Capecitabine: Given PO

Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: percentage of participants
0
Time Frame Adverse events occurred over a period of 3 months.
Adverse Event Reporting Description "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
 
Arm/Group Title Oxaliplatin and Capecitabine
Hide Arm/Group Description

21 day cycle with Oxaliplatin 50mg/m^2 day 1 and day 8 administered IV, Capecitabine 750 mg/m^2 bid p.o. daily from day 1 to day 14

Oxaliplatin: Given IV

Capecitabine: Given PO

All-Cause Mortality
Oxaliplatin and Capecitabine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Oxaliplatin and Capecitabine
Affected / at Risk (%) # Events
Total   1/4 (25.00%)    
Infections and infestations   
Colitis, infectious (e.g., Clostridium difficile) * 1  1/4 (25.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, meddra10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oxaliplatin and Capecitabine
Affected / at Risk (%) # Events
Total   2/4 (50.00%)    
Blood and lymphatic system disorders   
Hemoglobin decreased * 1  1/4 (25.00%)  1
Gastrointestinal disorders   
Abdominal distension * 1  1/4 (25.00%)  1
Abdominal pain * 1  2/4 (50.00%)  3
Constipation * 1  1/4 (25.00%)  2
Diarrhea * 1  2/4 (50.00%)  3
Flatulence * 1  1/4 (25.00%)  1
Gastrointestinal disorder * 1  1/4 (25.00%)  1
Lower gastrointestinal hemorrhage * 1  1/4 (25.00%)  1
Nausea * 1  2/4 (50.00%)  2
Stomach pain * 1  1/4 (25.00%)  1
General disorders   
Chills * 1  1/4 (25.00%)  1
Fatigue * 1  2/4 (50.00%)  4
Fever * 1  1/4 (25.00%)  1
Injection site reaction * 1  1/4 (25.00%)  1
Pain * 1  1/4 (25.00%)  1
Infections and infestations   
Colitis, infectious (e.g., Clostridium difficile) * 1  1/4 (25.00%)  1
Investigations   
Alanine aminotransferase increased * 1  2/4 (50.00%)  4
Alkaline phosphatase increased * 1  2/4 (50.00%)  4
Aspartate aminotransferase increased * 1  2/4 (50.00%)  4
Creatinine increased * 1  2/4 (50.00%)  3
Leukocyte count decreased * 1  1/4 (25.00%)  1
Lymphocyte count decreased * 1  1/4 (25.00%)  1
Platelet count decreased * 1  1/4 (25.00%)  3
Metabolism and nutrition disorders   
Anorexia * 1  2/4 (50.00%)  2
Blood glucose increased * 1  2/4 (50.00%)  4
Blood uric acid increased * 1  2/4 (50.00%)  4
Dehydration * 1  1/4 (25.00%)  1
Serum albumin decreased * 1  2/4 (50.00%)  4
Serum calcium decreased * 1  1/4 (25.00%)  1
Serum calcium increased * 1  1/4 (25.00%)  1
Serum magnesium decreased * 1  2/4 (50.00%)  2
Serum phosphate decreased * 1  1/4 (25.00%)  2
Serum potassium decreased * 1  1/4 (25.00%)  1
Serum potassium increased * 1  1/4 (25.00%)  2
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/4 (25.00%)  1
Muscle weakness * 1  1/4 (25.00%)  1
Pain in extremity * 1  1/4 (25.00%)  1
Nervous system disorders   
Dizziness * 1  1/4 (25.00%)  2
Headache * 1  2/4 (50.00%)  2
Peripheral sensory neuropathy * 1  2/4 (50.00%)  6
Taste alteration * 1  1/4 (25.00%)  1
Psychiatric disorders   
Anxiety * 1  1/4 (25.00%)  1
Insomnia * 1  1/4 (25.00%)  1
Respiratory, thoracic and mediastinal disorders   
Pharyngolaryngeal pain * 1  1/4 (25.00%)  1
Voice alteration * 1  2/4 (50.00%)  2
Skin and subcutaneous tissue disorders   
Pruritus * 1  2/4 (50.00%)  3
Rash desquamating * 1  2/4 (50.00%)  5
Vascular disorders   
Flushing * 1  1/4 (25.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, meddra10.0
Due to Sorafenib becoming a first line treatment for HCC, the designed treatment became less competitive. The company Sanofi decided not to continue support. Study was terminated after accrual of 4 of the 32 planned patients.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeffrey Longmate, Ph.D.
Organization: City of Hope
Phone: 626-256-4673 ext 62478
EMail: jlongmate@coh.org
Layout table for additonal information
Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT03026803     History of Changes
Other Study ID Numbers: 05195
First Submitted: January 17, 2017
First Posted: January 20, 2017
Results First Submitted: January 19, 2017
Results First Posted: March 10, 2017
Last Update Posted: April 13, 2017