Clinical Trial Results:
Phase II study with cetuximab, irinotecan and sunitinib (CIS) for patients with treatment resistant colorectal cancer.
Summary
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EudraCT number |
2007-004232-22 |
Trial protocol |
DK |
Global end of trial date |
07 May 2009
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Results information
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Results version number |
v1(current) |
This version publication date |
18 Mar 2021
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First version publication date |
18 Mar 2021
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
SIC
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Odense University Hospital
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Sponsor organisation address |
J. B. Winsløws Vej 2, entrance 140, basement, Odense C, Denmark, 5000
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Public contact |
Ida Coordt Elle, Odense University Hospital, +45 29335922, ida.coordt.elle@rsyd.dk
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Scientific contact |
Per Pfeiffer, Odense University Hospital, +45 26283844, per.pfeiffer@rsyd.dk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Jun 2010
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
07 May 2009
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To investigate the combination of Cetuximab, Irinotecan and Sunitinib (CIS or SIC) for treatment of patients with treatment-resistant colorectal cancer.
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Protection of trial subjects |
Administration of pre-medication to minimize adverse reactions.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
04 Jan 2008
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 55
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Worldwide total number of subjects |
55
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EEA total number of subjects |
55
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
40
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From 65 to 84 years |
15
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85 years and over |
0
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Recruitment
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Recruitment details |
November 2007-January 2009. Follow-up until disease progression. Expected number of patients: 55. | ||||||
Pre-assignment
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Screening details |
In Denmark, approximately 150 patients per year will be of adequate performance status to be offered 3rd line chemotherapy. Before the introduction of Cetuximab and Irinotecan, there was no 3rd line treatment to offer these patients. Adding Sunitinib to the regimen is expected to prolong PFS and thereby quality of life for these patients. | ||||||
Period 1
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Period 1 title |
Trial period (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Experimental | ||||||
Arm description |
Cetuximab 500 mg/m² i.v. day 1 every 2 weeks. Irinotecan 180 mg/m² i.v. day 1 every 2 weeks. Sunitinib 25 mg p.o. daily for 4 weeks and afterwards 37.5 mg daily. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Cetuximab
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution and suspension for suspension for injection in pre-filled syringe
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Routes of administration |
Intravenous use
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Dosage and administration details |
500 mg/m2 on day 1 every two weeks.
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Investigational medicinal product name |
Irinotecan
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solvent for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
180 mg/m2 on day 1 every two weeks.
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Investigational medicinal product name |
Sunitinib
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Investigational medicinal product code |
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Other name |
Sutent
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
25 mg per day for 4 weeks and then 37.5 mg per day.
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Baseline characteristics reporting groups
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Reporting group title |
Trial period
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Patients
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Subject analysis set type |
Full analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All patients in the study.
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End points reporting groups
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Reporting group title |
Experimental
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Reporting group description |
Cetuximab 500 mg/m² i.v. day 1 every 2 weeks. Irinotecan 180 mg/m² i.v. day 1 every 2 weeks. Sunitinib 25 mg p.o. daily for 4 weeks and afterwards 37.5 mg daily. | ||
Subject analysis set title |
Patients
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All patients in the study.
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End point title |
Progression-free survival [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
24 months
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The study was not deemed publishable; therefore no thurough analysis of the data was performed. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Last treatment+30 days.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
23.1
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Reporting groups
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Reporting group title |
Patients
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |