Trial Outcomes & Findings for Irinotecan and Cetuximab for Colorectal Cancer as Second Line Therapy (NCT NCT00336856)
NCT ID: NCT00336856
Last Updated: 2016-07-12
Results Overview
Percentage of partial responses (PR) + complete responses (CR).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
every 6 - 8 weeks, up to 30 months
Results posted on
2016-07-12
Participant Flow
Participant milestones
| Measure |
IRINOTECAN AND CETUXIMAB
Subjects with metastatic, CRC who have failed a first-line chemotherapeutic regimen containing oxaliplatin and a fluoropyrimidine, and who have not previously received irinotecan or cetuximab for treatment of CRC
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
IRINOTECAN AND CETUXIMAB
Subjects with metastatic, CRC who have failed a first-line chemotherapeutic regimen containing oxaliplatin and a fluoropyrimidine, and who have not previously received irinotecan or cetuximab for treatment of CRC
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Found ineligible at time of analysis
|
1
|
Baseline Characteristics
Irinotecan and Cetuximab for Colorectal Cancer as Second Line Therapy
Baseline characteristics by cohort
| Measure |
IRINOTECAN AND CETUXIMAB
n=31 Participants
Subjects with metastatic, CRC who have failed a first-line chemotherapeutic regimen containing oxaliplatin and a fluoropyrimidine, and who have not previously received irinotecan or cetuximab for treatment of CRC who received Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV), followed by 500 mg/m2 every 2 weeks IV
|
|---|---|
|
Age, Continuous
|
61.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: every 6 - 8 weeks, up to 30 monthsPercentage of partial responses (PR) + complete responses (CR).
Outcome measures
| Measure |
IRINOTECAN AND CETUXIMAB
n=31 Participants
Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks IV over 60 minutes.
Irinotecan administered at a dose of 150 or 180 mg/m2 IV over 60 minutes every two weeks.
|
|---|---|
|
Response Rate (RR)
|
6 percentage of participants
Interval 0.79 to 21.0
|
SECONDARY outcome
Timeframe: Up to 30 monthstime from start of protocol therapy until objective tumor progression
Outcome measures
| Measure |
IRINOTECAN AND CETUXIMAB
n=31 Participants
Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks IV over 60 minutes.
Irinotecan administered at a dose of 150 or 180 mg/m2 IV over 60 minutes every two weeks.
|
|---|---|
|
Time to Progression
|
2.4 months
Interval 1.3 to 4.6
|
SECONDARY outcome
Timeframe: Up to 30 monthstime from start of protocol therapy until death from any cause
Outcome measures
| Measure |
IRINOTECAN AND CETUXIMAB
n=31 Participants
Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks IV over 60 minutes.
Irinotecan administered at a dose of 150 or 180 mg/m2 IV over 60 minutes every two weeks.
|
|---|---|
|
Overall Survival
|
9.3 months
Interval 5.1 to 15.0
|
Adverse Events
IRINOTECAN AND CETUXIMAB
Serious events: 13 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IRINOTECAN AND CETUXIMAB
n=32 participants at risk
Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks IV over 60 minutes.
Irinotecan administered at a dose of 150 or 180 mg/m2 IV over 60 minutes every two weeks.
|
|---|---|
|
Investigations
Lymphopenia
|
3.1%
1/32
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
6.2%
2/32
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia, Atrial fibrillation
|
3.1%
1/32
|
|
Cardiac disorders
Cardiac General - Other
|
3.1%
1/32
|
|
Vascular disorders
Hypotension
|
3.1%
1/32
|
|
Blood and lymphatic system disorders
INR (International Normalized Ratio of prothrombin time)
|
3.1%
1/32
|
|
General disorders
Constitutional Symptoms - Other
|
3.1%
1/32
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
3.1%
1/32
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10^9 cells/L)
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
3.1%
1/32
|
|
Metabolism and nutrition disorders
Dehydration
|
3.1%
1/32
|
|
Gastrointestinal disorders
Diarrhea
|
3.1%
1/32
|
|
Gastrointestinal disorders
Fistula, GI, Abdomen NOS
|
3.1%
1/32
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
3.1%
1/32
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32
|
|
Gastrointestinal disorders
Obstruction, GI, Colon
|
6.2%
2/32
|
|
Gastrointestinal disorders
Perforation, GI, Ileum
|
3.1%
1/32
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
2/32
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Abdomen NOS
|
3.1%
1/32
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Wound
|
3.1%
1/32
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia
|
3.1%
1/32
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
3.1%
1/32
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
3.1%
1/32
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
3.1%
1/32
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
3.1%
1/32
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
3.1%
1/32
|
|
Nervous system disorders
Neuropathy: motor
|
3.1%
1/32
|
|
Nervous system disorders
Neuropathy: sensory
|
3.1%
1/32
|
|
Gastrointestinal disorders
Pain, Abdomen NOS
|
9.4%
3/32
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
3.1%
1/32
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
3.1%
1/32
|
|
Renal and urinary disorders
Renal failure
|
3.1%
1/32
|
Other adverse events
| Measure |
IRINOTECAN AND CETUXIMAB
n=32 participants at risk
Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks IV over 60 minutes.
Irinotecan administered at a dose of 150 or 180 mg/m2 IV over 60 minutes every two weeks.
|
|---|---|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
3.1%
1/32
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
3.1%
1/32
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
6.2%
2/32
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
6.2%
2/32
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
3.1%
1/32
|
|
Metabolism and nutrition disorders
Anorexia
|
40.6%
13/32
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
6.2%
2/32
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
3.1%
1/32
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
3.1%
1/32
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
3.1%
1/32
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
3.1%
1/32
|
|
Gastrointestinal disorders
Cheilitis
|
3.1%
1/32
|
|
Psychiatric disorders
Confusion
|
3.1%
1/32
|
|
Gastrointestinal disorders
Constipation
|
53.1%
17/32
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
2/32
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
2/32
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
3.1%
1/32
|
|
Gastrointestinal disorders
Diarrhea
|
65.6%
21/32
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
3.1%
1/32
|
|
Nervous system disorders
Dizziness
|
9.4%
3/32
|
|
Eye disorders
Dry eye syndrome
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
15.6%
5/32
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
3.1%
1/32
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
25.0%
8/32
|
|
General disorders
Edema: limb
|
6.2%
2/32
|
|
Gastrointestinal disorders
Esophagitis
|
3.1%
1/32
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
68.8%
22/32
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9 cells/L)
|
9.4%
3/32
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
2/32
|
|
Injury, poisoning and procedural complications
Fracture
|
3.1%
1/32
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
15.6%
5/32
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
34.4%
11/32
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
3.1%
1/32
|
|
Blood and lymphatic system disorders
Hemoglobin
|
31.2%
10/32
|
|
Gastrointestinal disorders
Hemorrhage, GI, Lower GI NOS
|
3.1%
1/32
|
|
Gastrointestinal disorders
Hemorrhage, GI, Rectum
|
3.1%
1/32
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.1%
1/32
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
3.1%
1/32
|
|
Vascular disorders
Hypotension
|
3.1%
1/32
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.1%
1/32
|
|
Infections and infestations
Infection - Other
|
3.1%
1/32
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Bladder (urinary)
|
3.1%
1/32
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Blood
|
3.1%
1/32
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Skin (cellulitis)
|
3.1%
1/32
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Upper airway NOS
|
9.4%
3/32
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Urinary tract NOS
|
6.2%
2/32
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Vulva
|
3.1%
1/32
|
|
General disorders
Injection site reaction/extravasation changes
|
3.1%
1/32
|
|
Psychiatric disorders
Insomnia
|
3.1%
1/32
|
|
Investigations
Leukocytes (total WBC)
|
34.4%
11/32
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
3.1%
1/32
|
|
Nervous system disorders
Memory impairment
|
3.1%
1/32
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other
|
3.1%
1/32
|
|
Psychiatric disorders
Mood alteration, Anxiety
|
3.1%
1/32
|
|
Psychiatric disorders
Mood alteration, Depression
|
3.1%
1/32
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam), Oral cavity
|
25.0%
8/32
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
3.1%
1/32
|
|
Gastrointestinal disorders
Nausea
|
40.6%
13/32
|
|
Nervous system disorders
Neurology - Other
|
12.5%
4/32
|
|
Nervous system disorders
Neuropathy: motor
|
12.5%
4/32
|
|
Nervous system disorders
Neuropathy: sensory
|
28.1%
9/32
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
28.1%
9/32
|
|
Gastrointestinal disorders
Obstruction, GI, Small bowel NOS
|
6.2%
2/32
|
|
Eye disorders
Ocular/Visual - Other
|
3.1%
1/32
|
|
General disorders
Pain - Other
|
6.2%
2/32
|
|
Gastrointestinal disorders
Pain, Abdomen NOS
|
31.2%
10/32
|
|
Musculoskeletal and connective tissue disorders
Pain, Back
|
12.5%
4/32
|
|
General disorders
Pain, Chest/thorax NOS
|
3.1%
1/32
|
|
Musculoskeletal and connective tissue disorders
Pain, Extremity-limb
|
6.2%
2/32
|
|
Ear and labyrinth disorders
Pain, Middle ear
|
3.1%
1/32
|
|
Gastrointestinal disorders
Pain, Rectum
|
3.1%
1/32
|
|
Investigations
Platelets
|
6.2%
2/32
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
12.5%
4/32
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
31.2%
10/32
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
59.4%
19/32
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
12.5%
4/32
|
|
Renal and urinary disorders
Renal failure
|
3.1%
1/32
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
6.2%
2/32
|
|
General disorders
Rigors/chills
|
3.1%
1/32
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
3.1%
1/32
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia, Sinus bradycardia
|
3.1%
1/32
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
6.2%
2/32
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
9.4%
3/32
|
|
Gastrointestinal disorders
Ulcer, GI, Stomach
|
3.1%
1/32
|
|
General disorders
Ulceration
|
3.1%
1/32
|
|
Eye disorders
Vitreous hemorrhage
|
3.1%
1/32
|
|
Gastrointestinal disorders
Vomiting
|
9.4%
3/32
|
|
Investigations
Weight gain
|
3.1%
1/32
|
|
Investigations
Weight loss
|
15.6%
5/32
|
|
Injury, poisoning and procedural complications
Wound complication, non-infectious
|
3.1%
1/32
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place