Trial Outcomes & Findings for Chemoembolization Using Doxorubicin in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery (NCT NCT00293397)

Last Updated: 2018-07-18

Results Overview

Safety was assessed using the CTCAE v 3.0 criteria, reported are the number of participants that experienced at least 1 event that was grade 2 (moderate) or higher.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

1 month

Results posted on

2018-07-18

Participant Flow

20 patients with unresectable hepatocellular carcinoma (HCC) were enrolled at Johns Hopkins Hospital to undergo treatment with drug-eluting beads (DEBs) infused with doxorubicin. The last patient was enrolled in Dec 2007.

Participant milestones

Participant milestones
Measure	Drug-eluting Bead Transarterial Chemoembolziation (DEB-TACE) Patients undergo DEB-TACE procedures utilizing LC Beads, polyvinyl alcohol microspheres with diameters of 100-300um or 300-500um, which are loaded with 100mg of doxorubicin hydrochloride and mixed with an equal volume of nonionic contrast media. doxorubicin hydrochloride: Doxorubicin eluting beads
Overall Study STARTED	20
Overall Study Received First DEB-TACE	19
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Drug-eluting Bead Transarterial Chemoembolziation (DEB-TACE) Patients undergo DEB-TACE procedures utilizing LC Beads, polyvinyl alcohol microspheres with diameters of 100-300um or 300-500um, which are loaded with 100mg of doxorubicin hydrochloride and mixed with an equal volume of nonionic contrast media. doxorubicin hydrochloride: Doxorubicin eluting beads
Overall Study Death	2

Baseline Characteristics

Chemoembolization Using Doxorubicin in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Drug-eluting Bead Transarterial Chemoembolziation (DEB-TACE) n=20 Participants Patients undergo DEB-TACE procedures utilizing LC Beads, polyvinyl alcohol microspheres with diameters of 100-300um or 300-500um, which are loaded with 100mg of doxorubicin hydrochloride and mixed with an equal volume of nonionic contrast media. doxorubicin hydrochloride: Doxorubicin eluting beads
Age, Continuous	64 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants
Barcelona Clinic Liver Cancer (BCLC) grade BCLC A	6 Participants n=5 Participants
Barcelona Clinic Liver Cancer (BCLC) grade BCLC B	2 Participants n=5 Participants
Barcelona Clinic Liver Cancer (BCLC) grade BCLC C	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Population: 19 of 20 patients were assessed at 1 month.

Safety was assessed using the CTCAE v 3.0 criteria, reported are the number of participants that experienced at least 1 event that was grade 2 (moderate) or higher.

Outcome measures

Outcome measures
Measure	Drug-eluting Bead Transarterial Chemoembolziation (DEB-TACE) n=19 Participants Patients undergo DEB-TACE procedures utilizing LC Beads, polyvinyl alcohol microspheres with diameters of 100-300um or 300-500um, which are loaded with 100mg of doxorubicin hydrochloride and mixed with an equal volume of nonionic contrast media. doxorubicin hydrochloride: Doxorubicin eluting beads
Safety Grade 2	16 Participants
Safety Grade 3	3 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 19 of 20 patients were assessed at 6 months.

Safety was assessed using the CTCAE v 3.0 criteria, reported are the number of participants that experienced at least 1 event that was grade 2 (moderate) or higher.

Outcome measures

Outcome measures
Measure	Drug-eluting Bead Transarterial Chemoembolziation (DEB-TACE) n=19 Participants Patients undergo DEB-TACE procedures utilizing LC Beads, polyvinyl alcohol microspheres with diameters of 100-300um or 300-500um, which are loaded with 100mg of doxorubicin hydrochloride and mixed with an equal volume of nonionic contrast media. doxorubicin hydrochloride: Doxorubicin eluting beads
Safety Grade 2	8 Participants
Safety Grade 3	1 Participants

PRIMARY outcome

Timeframe: 1 month

Population: 19 of 20 patients were assessed at 1 month.

Efficacy as assessed by radiographic tumor response using EASL criteria at baseline and at 1 month post-TACE Complete Response (CR): Achieving 100% tumor necrosis of targeted lesions Partial Response (PR): Demonstrating greater than 50% tumor necrosis in targeted lesions Progressive Disease (PD): Reappearance of or increased tumor enhancement greater than 25% in targeted lesions Stable Disease (SD): Not meeting requirements for CR or PR and not demonstrating evidence of progression in targeted lesions.

Outcome measures

Outcome measures
Measure	Drug-eluting Bead Transarterial Chemoembolziation (DEB-TACE) n=19 Participants Patients undergo DEB-TACE procedures utilizing LC Beads, polyvinyl alcohol microspheres with diameters of 100-300um or 300-500um, which are loaded with 100mg of doxorubicin hydrochloride and mixed with an equal volume of nonionic contrast media. doxorubicin hydrochloride: Doxorubicin eluting beads
Efficacy - Tumor Response by the European Association for the Study of the Liver (EASL) Criteria 1 month post-TACE : Complete Response (CR)	6 Participants
Efficacy - Tumor Response by the European Association for the Study of the Liver (EASL) Criteria 1 month post-TACE : Partial Response (PR)	6 Participants
Efficacy - Tumor Response by the European Association for the Study of the Liver (EASL) Criteria 1 month post-TACE : Stable Disease (SD)	8 Participants
Efficacy - Tumor Response by the European Association for the Study of the Liver (EASL) Criteria 1 month post-TACE : Progressive Disease	0 Participants
Efficacy - Tumor Response by the European Association for the Study of the Liver (EASL) Criteria Disease control rate (CR + PR + SD)	19 Participants

PRIMARY outcome

Timeframe: 1 month

Population: 19 of 20 patients were assessed at 1 month.

Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, 1 month post treatment. Complete Response (CR): Disappearance of all lesions targeted by therapy Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by therapy Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by therapy Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD.

Outcome measures

Outcome measures
Measure	Drug-eluting Bead Transarterial Chemoembolziation (DEB-TACE) n=19 Participants Patients undergo DEB-TACE procedures utilizing LC Beads, polyvinyl alcohol microspheres with diameters of 100-300um or 300-500um, which are loaded with 100mg of doxorubicin hydrochloride and mixed with an equal volume of nonionic contrast media. doxorubicin hydrochloride: Doxorubicin eluting beads
Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1 month post-TACE : Complete Response (CR)	0 Participants
Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1 month post-TACE : Partial Response (PR)	2 Participants
Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1 month post-TACE : Stable Disease (SD)	18 Participants
Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1 month post-TACE : Progressive Disease	0 Participants
Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) Disease control rate (CR + PR + SD)	19 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 19 of 20 patients were assessed.

Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, and at 6 months post treatment. Complete Response (CR): Disappearance of all lesions targeted by therapy Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by therapy Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by therapy Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD.

Outcome measures

Outcome measures
Measure	Drug-eluting Bead Transarterial Chemoembolziation (DEB-TACE) n=19 Participants Patients undergo DEB-TACE procedures utilizing LC Beads, polyvinyl alcohol microspheres with diameters of 100-300um or 300-500um, which are loaded with 100mg of doxorubicin hydrochloride and mixed with an equal volume of nonionic contrast media. doxorubicin hydrochloride: Doxorubicin eluting beads
Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 6 months post-TACE : Complete Response (CR)	1 Participants
Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 6 months post-TACE : Partial Response (PR)	7 Participants
Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 6 months post-TACE : Stable Disease (SD)	11 Participants
Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 6 months post-TACE : Progressive Disease (PD)	1 Participants
Efficacy - Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) Disease control rate (CR + PR + SD)	19 Participants

PRIMARY outcome

Timeframe: 1 Year

Population: 20 patients were assessed.

Presented are the counts of patients that have survived up to 1 year.

Outcome measures

Outcome measures
Measure	Drug-eluting Bead Transarterial Chemoembolziation (DEB-TACE) n=20 Participants Patients undergo DEB-TACE procedures utilizing LC Beads, polyvinyl alcohol microspheres with diameters of 100-300um or 300-500um, which are loaded with 100mg of doxorubicin hydrochloride and mixed with an equal volume of nonionic contrast media. doxorubicin hydrochloride: Doxorubicin eluting beads
Efficacy - Overall Survival	13 Participants

PRIMARY outcome

Timeframe: 2 Years

Population: 20 patients were assessed.

Presented are the counts of patients that have survived up to 2 years.

Outcome measures

Outcome measures
Measure	Drug-eluting Bead Transarterial Chemoembolziation (DEB-TACE) n=20 Participants Patients undergo DEB-TACE procedures utilizing LC Beads, polyvinyl alcohol microspheres with diameters of 100-300um or 300-500um, which are loaded with 100mg of doxorubicin hydrochloride and mixed with an equal volume of nonionic contrast media. doxorubicin hydrochloride: Doxorubicin eluting beads
Efficacy - Overall Survival	11 Participants

Adverse Events

Drug-eluting Bead Transarterial Chemoembolziation (DEB-TACE)

Serious events: 2 serious events

Other events: 20 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Drug-eluting Bead Transarterial Chemoembolziation (DEB-TACE) n=20 participants at risk Patients undergo DEB-TACE procedures utilizing LC Beads, polyvinyl alcohol microspheres with diameters of 100-300um or 300-500um, which are loaded with 100mg of doxorubicin hydrochloride and mixed with an equal volume of nonionic contrast media. doxorubicin hydrochloride: Doxorubicin eluting beads
Hepatobiliary disorders Liver failure	5.0% 1/20 • Number of events 1 • 3 months
Hepatobiliary disorders Cholecystitis	5.0% 1/20 • Number of events 1 • 3 months

Other adverse events

Other adverse events
Measure	Drug-eluting Bead Transarterial Chemoembolziation (DEB-TACE) n=20 participants at risk Patients undergo DEB-TACE procedures utilizing LC Beads, polyvinyl alcohol microspheres with diameters of 100-300um or 300-500um, which are loaded with 100mg of doxorubicin hydrochloride and mixed with an equal volume of nonionic contrast media. doxorubicin hydrochloride: Doxorubicin eluting beads
General disorders Fatigue	65.0% 13/20 • Number of events 13 • 3 months
Gastrointestinal disorders Post-embolization syndrome	5.0% 1/20 • Number of events 1 • 3 months
Gastrointestinal disorders Abdominal pain	40.0% 8/20 • Number of events 8 • 3 months
General disorders Fever	15.0% 3/20 • Number of events 3 • 3 months
Gastrointestinal disorders Nausea	15.0% 3/20 • Number of events 3 • 3 months
Gastrointestinal disorders Vomiting	5.0% 1/20 • Number of events 1 • 3 months
Blood and lymphatic system disorders Anemia	45.0% 9/20 • Number of events 9 • 3 months
Investigations Leukocytopenia	25.0% 5/20 • Number of events 5 • 3 months
Investigations Thrombocytopenia	15.0% 3/20 • Number of events 3 • 3 months
Investigations Elevated liver enzymes	30.0% 6/20 • Number of events 6 • 3 months
Metabolism and nutrition disorders Anorexia	35.0% 7/20 • Number of events 7 • 3 months
Investigations Weight loss	30.0% 6/20 • Number of events 6 • 3 months
Skin and subcutaneous tissue disorders Alopecia	5.0% 1/20 • Number of events 1 • 3 months
Psychiatric disorders Decreased libido	5.0% 1/20 • Number of events 1 • 3 months
Gastrointestinal disorders Diarrhea	5.0% 1/20 • Number of events 1 • 3 months
Gastrointestinal disorders Gastroenteritis	5.0% 1/20 • Number of events 1 • 3 months
Gastrointestinal disorders Pancreatitis	5.0% 1/20 • Number of events 1 • 3 months

Additional Information

Jean-Francois Geschwind, MD

Yale University

Phone: 203-785-5865

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place