Trial Outcomes & Findings for Chemoembolization Using Irinotecan in Treating Patients With Liver Metastases From Metastatic Colon or Rectal Cancer (NCT NCT01285102)

NCT ID: NCT01285102

Last Updated: 2021-12-20

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 4 participants
• Primary outcome timeframe: Duration of time from start of treatment to progression
• Results posted on: 2021-12-20

Participant Flow

Participant milestones

Measure	DEBIRI With Hepatic Artery Embolization Patients receive irinotecan-eluting beads via hepatic artery embolization every 3 weeks for up to 3 (unilobar disease) or 4 (bi-lobar disease) courses in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	DEBIRI With Hepatic Artery Embolization Patients receive irinotecan-eluting beads via hepatic artery embolization every 3 weeks for up to 3 (unilobar disease) or 4 (bi-lobar disease) courses in the absence of disease progression or unacceptable toxicity.
Overall Study Closed to accrual by sponsor due to poor accrual and challenge with dosing	4

Baseline Characteristics

Chemoembolization Using Irinotecan in Treating Patients With Liver Metastases From Metastatic Colon or Rectal Cancer

Baseline characteristics by cohort

Measure	DEBIRI With Hepatic Artery Embolization n=4 Participants Patients receive irinotecan-eluting beads via hepatic artery embolization every 3 weeks for up to 3 (unilobar disease) or 4 (bi-lobar disease) courses in the absence of disease progression or unacceptable toxicity.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	77.5 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Duration of time from start of treatment to progression

Population: Study was closed to accrual by sponsor due to poor accrual and challenge with dosing. No data was generated.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: First treatment then 30 days after completion of treatment then every 3 months for 2 years

Population: Study was closed to accrual by sponsor due to poor accrual and challenge with dosing. No data was generated.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 30 days after completion of treatment then every 3 months for 2 years

Population: Study was closed to accrual by sponsor due to poor accrual and challenge with dosing. No data was generated.

Outcome measures

Outcome data not reported

Adverse Events

DEBIRI With Hepatic Artery Embolization

Serious events: 0 serious events

Other events: 4 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	DEBIRI With Hepatic Artery Embolization n=4 participants at risk Patients receive irinotecan-eluting beads via hepatic artery embolization every 3 weeks for up to 3 (unilobar disease) or 4 (bi-lobar disease) courses in the absence of disease progression or unacceptable toxicity.
Gastrointestinal disorders Elevated ALP	100.0% 4/4
Gastrointestinal disorders Elevated AST	100.0% 4/4
Gastrointestinal disorders Elevated ALT	100.0% 4/4
Gastrointestinal disorders Elevated bilirubin	75.0% 3/4
Gastrointestinal disorders Biliary obstruction	25.0% 1/4

Additional Information

Dr. Efrat Dotan

Fox Chase Cancer Center

Phone: 215-214-4283

Email: Efrat.Dotan@fccc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place