Trial Outcomes & Findings for Chemoembolization, Irinotecan Bead, Second Line Chemotherapy Treatment of Unresectable Metastatic Colorectal Cancer (NCT NCT00816777)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

4 participants

Primary outcome timeframe

1 year

Results posted on

2018-09-07

Participant Flow

Participant milestones

Participant milestones
Measure	Chemoembolization Chemoembolization with Irinotecan Bead in combination with Intravenous Chemotherapy Group (test arm) Chemoembolization with irinotecan Bead: Intra arterial chemoembolization using Irinotecan Bead 100mg irinotecan per procedure in combination with irinotecan monotherapy 250mg/m2 alternating on a 3 weekly schedule Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks	Chemotherapy Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks
Overall Study STARTED	2	2
Overall Study COMPLETED	2	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Chemoembolization, Irinotecan Bead, Second Line Chemotherapy Treatment of Unresectable Metastatic Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemoembolization n=2 Participants Chemoembolization with Irinotecan Bead in combination with Intravenous Chemotherapy Group (test arm) Chemoembolization with irinotecan Bead: Intra arterial chemoembolization using Irinotecan Bead 100mg irinotecan per procedure in combination with irinotecan monotherapy 250mg/m2 alternating on a 3 weekly schedule Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks	Chemotherapy n=2 Participants Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks	Total n=4 Participants Total of all reporting groups
Age, Continuous	56 years n=99 Participants	63 years n=107 Participants	58.25 years n=206 Participants
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Male	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Region of Enrollment United States	2 participants n=99 Participants	2 participants n=107 Participants	4 participants n=206 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: Data not collected study terminated early

0 - No data collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Study terminated ealry

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Study terminated ealry - data not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Early termination - data not collected

Data not collected - study terminated ealry

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Study terminated early. No Data collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Study terminated early

No data collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: Study terminated ealry no data collected

Outcome measures

Outcome data not reported

Adverse Events

Chemoembolization

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Chemotherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John Greenbaum

Generic Devices Consulting, Inc

Phone: 772-353-5301

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60