Trial Outcomes & Findings for Cetuximab Plus Irinotecan in Colorectal Cancer Patients Who Progressed After Failure With Cetuximab Plus Irinotecan (NCT NCT01004159)

NCT ID: NCT01004159

Last Updated: 2015-10-19

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: 12 week
• Results posted on: 2015-10-19

Participant Flow

Participant milestones

Measure	Cetuximab With Irinotecan cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
Overall Study STARTED	20
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Measure	Cetuximab With Irinotecan cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
Overall Study Adverse Event	2
Overall Study Disease Progression	18

Baseline Characteristics

Cetuximab Plus Irinotecan in Colorectal Cancer Patients Who Progressed After Failure With Cetuximab Plus Irinotecan

Baseline characteristics by cohort

Measure	Cetuximab With Irinotecan n=20 Participants cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
Age, Continuous	64.6 years STANDARD_DEVIATION 10.7 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 week

Population: All treated and eligible patients

Outcome measures

Measure	Cetuximab With Irinotecan n=20 Participants cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
12-week Progression Free Survival Rate Upon Escalation of Cetuximab Dose to 500mg/m2 in Combination With Irinotecan After Progression on Standard Dose Therapy in Patients With KRS Wild Type Colorectal Cancer	50 percentage of participants Interval 27.0 to 69.0

SECONDARY outcome

Timeframe: 18 months

Population: All treated and eligible patients

Outcome measures

Measure	Cetuximab With Irinotecan n=20 Participants cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
Response Rate of Cetuximab 500mg/m2/Week in Combination With Irinotecan in the Enrolled Patient Population	5 percentage of particitpants Interval 0.1 to 24.9

Adverse Events

Cetuximab With Irinotecan

Serious events: 8 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cetuximab With Irinotecan n=20 participants at risk cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
Gastrointestinal disorders Diarrhoea	5.0% 1/20 • Number of events 2
Gastrointestinal disorders Intestinal obstruction	5.0% 1/20 • Number of events 4
Gastrointestinal disorders Small intestinal obstruction	5.0% 1/20 • Number of events 2
General disorders Pain	5.0% 1/20 • Number of events 2
Immune system disorders Hypersensitivity	5.0% 1/20 • Number of events 2
Infections and infestations Infection	10.0% 2/20 • Number of events 4
Metabolism and nutrition disorders Hyperglycaemia	5.0% 1/20 • Number of events 2
Vascular disorders Deep vein thrombosis	5.0% 1/20 • Number of events 2

Other adverse events

Measure	Cetuximab With Irinotecan n=20 participants at risk cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
Blood and lymphatic system disorders Leukopenia	20.0% 4/20 • Number of events 12
Blood and lymphatic system disorders Lymphopenia	20.0% 4/20 • Number of events 24
Blood and lymphatic system disorders Neutropenia	15.0% 3/20 • Number of events 12
Blood and lymphatic system disorders Thrombocytopenia	5.0% 1/20 • Number of events 2
Eye disorders Dry eye	5.0% 1/20 • Number of events 2
Eye disorders Lacrimation increased	5.0% 1/20 • Number of events 2
Gastrointestinal disorders Abdominal pain	5.0% 1/20 • Number of events 2
Gastrointestinal disorders Constipation	5.0% 1/20 • Number of events 2
Gastrointestinal disorders Diarrhoea	20.0% 4/20 • Number of events 10
Gastrointestinal disorders Gastrooesophageal reflux disease	5.0% 1/20 • Number of events 2
Gastrointestinal disorders Nausea	15.0% 3/20 • Number of events 6
Gastrointestinal disorders Oral pain	5.0% 1/20 • Number of events 2
Gastrointestinal disorders Vomiting	15.0% 3/20 • Number of events 8
General disorders Fatigue	15.0% 3/20 • Number of events 8
General disorders Mucosal inflammation	5.0% 1/20 • Number of events 2
General disorders Pyrexia	5.0% 1/20 • Number of events 2
Hepatobiliary disorders Hyperbilirubinaemia	10.0% 2/20 • Number of events 6
Infections and infestations Herpes zoster	5.0% 1/20 • Number of events 2
Infections and infestations Infection	10.0% 2/20 • Number of events 6
Injury, poisoning and procedural complications Laceration	5.0% 1/20 • Number of events 2
Investigations Alanine aminotransferase increased	10.0% 2/20 • Number of events 4
Investigations Aspartate aminotransferase increased	10.0% 2/20 • Number of events 6
Investigations Blood alkaline phosphatase increased	15.0% 3/20 • Number of events 8
Investigations Blood bilirubin increased	5.0% 1/20 • Number of events 2
Investigations Electrocardiogram QT corrected interval prolonged	5.0% 1/20 • Number of events 2
Investigations Haemoglobin	5.0% 1/20 • Number of events 6
Investigations Haemoglobin decreased	10.0% 2/20 • Number of events 16
Investigations International normalised ratio	5.0% 1/20 • Number of events 2
Investigations International normalised ratio increased	5.0% 1/20 • Number of events 4
Investigations Weight decreased	15.0% 3/20 • Number of events 6
Metabolism and nutrition disorders Anorexia	30.0% 6/20 • Number of events 14
Metabolism and nutrition disorders Hyperglycaemia	15.0% 3/20 • Number of events 16
Metabolism and nutrition disorders Hypoalbuminaemia	15.0% 3/20 • Number of events 6
Metabolism and nutrition disorders Hypocalcaemia	5.0% 1/20 • Number of events 2
Metabolism and nutrition disorders Hypokalaemia	5.0% 1/20 • Number of events 2
Metabolism and nutrition disorders Hypomagnesaemia	45.0% 9/20 • Number of events 58
Musculoskeletal and connective tissue disorders Back pain	5.0% 1/20 • Number of events 2
Nervous system disorders Dizziness	10.0% 2/20 • Number of events 4
Nervous system disorders Restless legs syndrome	5.0% 1/20 • Number of events 2
Psychiatric disorders Insomnia	10.0% 2/20 • Number of events 4
Psychiatric disorders Mood altered	5.0% 1/20 • Number of events 2
Renal and urinary disorders Bladder pain	5.0% 1/20 • Number of events 2
Reproductive system and breast disorders Haematospermia	5.0% 1/20 • Number of events 2
Respiratory, thoracic and mediastinal disorders Cough	5.0% 1/20 • Number of events 2
Respiratory, thoracic and mediastinal disorders Hiccups	5.0% 1/20 • Number of events 4
Skin and subcutaneous tissue disorders Dermatitis acneiform	25.0% 5/20 • Number of events 12
Skin and subcutaneous tissue disorders Dry skin	10.0% 2/20 • Number of events 4
Skin and subcutaneous tissue disorders Pruritus	5.0% 1/20 • Number of events 4
Skin and subcutaneous tissue disorders Psoriasis	5.0% 1/20 • Number of events 2
Skin and subcutaneous tissue disorders Rash	10.0% 2/20 • Number of events 4
Vascular disorders Hypotension	10.0% 2/20 • Number of events 4

Additional Information

Senior Administrator, Compliance - Clinical Research Services

Roswell Park Cancer Institute

Phone: 716-845-2300

Results disclosure agreements

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