Trial Outcomes & Findings for A Study of Oxaliplatin and Capecitabine in Unresectable Metastatic Hepatocellular Cancer (NCT NCT03026803)

Last Updated: 2017-04-13

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Up to 2 years

Results posted on

2017-04-13

Participant Flow

Participant milestones

Participant milestones
Measure	Oxaliplatin and Capecitabine 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 Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Oxaliplatin and Capecitabine in Unresectable Metastatic Hepatocellular Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxaliplatin and Capecitabine n=4 Participants 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
Age, Continuous	71 years n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	4 Participants n=93 Participants
Region of Enrollment United States	4 participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Outcome measures

Outcome measures
Measure	Oxaliplatin and Capecitabine n=4 Participants 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
Response Rate	0 percentage of participants

Adverse Events

Oxaliplatin and Capecitabine

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Oxaliplatin and Capecitabine n=4 participants at risk 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
Infections and infestations Colitis, infectious (e.g., Clostridium difficile)	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Other adverse events

Other adverse events
Measure	Oxaliplatin and Capecitabine n=4 participants at risk 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
Blood and lymphatic system disorders Hemoglobin decreased	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal distension	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	50.0% 2/4 • Number of events 3 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Constipation	25.0% 1/4 • Number of events 2 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea	50.0% 2/4 • Number of events 3 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Flatulence	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastrointestinal disorder	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	50.0% 2/4 • Number of events 2 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Stomach pain	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chills	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	50.0% 2/4 • Number of events 4 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Injection site reaction	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Pain	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Colitis, infectious (e.g., Clostridium difficile)	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alanine aminotransferase increased	50.0% 2/4 • Number of events 4 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline phosphatase increased	50.0% 2/4 • Number of events 4 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Aspartate aminotransferase increased	50.0% 2/4 • Number of events 4 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	50.0% 2/4 • Number of events 3 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Leukocyte count decreased	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphocyte count decreased	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	25.0% 1/4 • Number of events 3 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Anorexia	50.0% 2/4 • Number of events 2 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Blood glucose increased	50.0% 2/4 • Number of events 4 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Blood uric acid increased	50.0% 2/4 • Number of events 4 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Dehydration	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum albumin decreased	50.0% 2/4 • Number of events 4 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum calcium decreased	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum calcium increased	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum magnesium decreased	50.0% 2/4 • Number of events 2 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum phosphate decreased	25.0% 1/4 • Number of events 2 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum potassium decreased	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Serum potassium increased	25.0% 1/4 • Number of events 2 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Back pain	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Muscle weakness	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dizziness	25.0% 1/4 • Number of events 2 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Headache	50.0% 2/4 • Number of events 2 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Peripheral sensory neuropathy	50.0% 2/4 • Number of events 6 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Taste alteration	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Anxiety	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Insomnia	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Voice alteration	50.0% 2/4 • Number of events 2 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Pruritus	50.0% 2/4 • Number of events 3 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Rash desquamating	50.0% 2/4 • Number of events 5 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Flushing	25.0% 1/4 • Number of events 1 • Adverse events occurred over a period of 3 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Additional Information

Jeffrey Longmate, Ph.D.

City of Hope

Phone: 626-256-4673

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place