Trial Outcomes & Findings for Cisplatin or Carboplatin and Sorafenib in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery (NCT NCT00875615)
NCT ID: NCT00875615
Last Updated: 2017-02-07
Results Overview
The number of subjects experiencing adverse events after receiving protocol therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
36 months
Results posted on
2017-02-07
Participant Flow
Participant milestones
| Measure |
Cisplatin or Carboplatin + Sorafenib
Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.
Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.
Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Cisplatin or Carboplatin + Sorafenib
Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.
Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.
Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Cisplatin or Carboplatin and Sorafenib in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
Baseline characteristics by cohort
| Measure |
Cisplatin or Carboplatin + Sorafenib
n=11 Participants
Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.
Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.
Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
|
Age, Continuous
|
65 years
n=99 Participants
|
|
Gender
Female
|
2 Participants
n=99 Participants
|
|
Gender
Male
|
9 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
|
Child-Pugh Score
Child-Pugh A
|
10 participants
n=99 Participants
|
|
Child-Pugh Score
Child-Pugh B
|
1 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: Of the 11 participants enrolled, 10 had results that were evaluable.
The number of subjects experiencing adverse events after receiving protocol therapy.
Outcome measures
| Measure |
Cisplatin or Carboplatin + Sorafenib
n=10 Participants
Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.
Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.
Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.
|
|---|---|
|
Number of Subjects Experiencing Adverse Events
|
2 participants
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: Of the 11 participants enrolled, 10 had results that were evaluable.
Number of patients achieving complete or partial response according to RECIST criteria
Outcome measures
| Measure |
Cisplatin or Carboplatin + Sorafenib
n=10 Participants
Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.
Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.
Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.
|
|---|---|
|
Number of Patients Achieving Clinical Benefit
|
6 participants
|
Adverse Events
Cisplatin or Carboplatin + Sorafenib
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cisplatin or Carboplatin + Sorafenib
n=10 participants at risk
Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.
Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.
Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.
|
|---|---|
|
Gastrointestinal disorders
Grade 1 Diarrhea
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Esophagheal Bleeding
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Hemorrhoidal Bleeding
|
10.0%
1/10 • Number of events 1
|
Additional Information
Lynn Feun MD
University of Miami Sylvester Comprehensive Cancer Center
Phone: 305-243-4981
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place