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Trial record 10 of 198 for:    colon cancer | ( Map: Colorado, United States )

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

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ClinicalTrials.gov Identifier: NCT00816777
Recruitment Status : Terminated (Lack of enrollment)
First Posted : January 5, 2009
Results First Posted : September 18, 2015
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
Biocompatibles UK Ltd
Information provided by (Responsible Party):
Generic Devices Consulting, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Unresectable Metastatic Colo-rectal Cancer
Interventions Procedure: Chemoembolization with irinotecan Bead
Drug: Irinotecan
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Chemoembolization Chemotherapy
Hide Arm/Group Description

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

Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks

Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks

Period Title: Overall Study
Started 2 2
Completed 2 2
Not Completed 0 0
Arm/Group Title Chemoembolization Chemotherapy Total
Hide Arm/Group Description

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

Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks

Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks

Total of all reporting groups
Overall Number of Baseline Participants 2 2 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 2 participants 2 participants 4 participants
56
(55 to 57)
63
(60 to 64)
58.25
(55 to 64)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
2
 100.0%
4
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
2
 100.0%
2
 100.0%
4
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 2 participants 4 participants
2 2 4
1.Primary Outcome
Title Progression Free Survival
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemoembolization Chemotherapy
Hide Arm/Group Description:

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

Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks

Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Toxicity, Adverse Events and Serious Adverse Events (NCI CTCAE v3.0)
Hide Description 0 - No data collected
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected study terminated early
Arm/Group Title Chemoembolization Chemotherapy
Hide Arm/Group Description:

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

Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks

Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Tumor Response (RECIST)
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated ealry
Arm/Group Title Chemoembolization Chemotherapy
Hide Arm/Group Description:

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

Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks

Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Local Tumor Response (Extent of Necrosis in the Treated Lesions)
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated ealry - data not collected
Arm/Group Title Chemoembolization Chemotherapy
Hide Arm/Group Description:

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

Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks

Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Hepatic Progression Free Survival
Hide Description Data not collected - study terminated ealry
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Early termination - data not collected
Arm/Group Title Chemoembolization Chemotherapy
Hide Arm/Group Description:

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

Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks

Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change in Tumor Marker
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early. No Data collected
Arm/Group Title Chemoembolization Chemotherapy
Hide Arm/Group Description:

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

Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks

Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Performance Status (ECOG)
Hide Description No data collected
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early
Arm/Group Title Chemoembolization Chemotherapy
Hide Arm/Group Description:

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

Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks

Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated ealry no data collected
Arm/Group Title Chemoembolization Chemotherapy
Hide Arm/Group Description:

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

Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks

Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 2 year
Adverse Event Reporting Description No adverse events reported
 
Arm/Group Title Chemoembolization Chemotherapy
Hide Arm/Group Description

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

Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks

Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks

All-Cause Mortality
Chemoembolization Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Chemoembolization Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Chemoembolization Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/2 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John Greenbaum
Organization: Generic Devices Consulting, Inc
Phone: 772-353-5301
EMail: genericd@bellsouth.net
Layout table for additonal information
Responsible Party: Generic Devices Consulting, Inc.
ClinicalTrials.gov Identifier: NCT00816777     History of Changes
Other Study ID Numbers: CA1013
IDE G070122 ( Other Identifier: FDA IDE )
First Submitted: January 2, 2009
First Posted: January 5, 2009
Results First Submitted: August 12, 2014
Results First Posted: September 18, 2015
Last Update Posted: September 7, 2018