Trial Outcomes & Findings for Cetuximab & Celecoxib for Metastatic Colorectal Cancer or Colorectal Cancer That Cannot Be Removed by Surgery (NCT NCT00466505)
NCT ID: NCT00466505
Last Updated: 2012-12-19
Results Overview
Number of days from study enrollment to evidence of progressive disease radiographically, with progression defined under RECIST criteria as at least 20% increase in sum of longest diameter of target lesions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
On study date to off study date in this study with median 9.76 months
Results posted on
2012-12-19
Participant Flow
Study recruitment period was May 2005 through January 2007.
A total of 18 people signed consent to participate in this study. One was determined ineligible, for a total of 17 patients on study.
Participant milestones
| Measure |
Therapeutic Intervention
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
Therapeutic Intervention
|
|---|---|
|
Overall Study
disease progression
|
13
|
|
Overall Study
Adverse Event
|
4
|
Baseline Characteristics
Cetuximab & Celecoxib for Metastatic Colorectal Cancer or Colorectal Cancer That Cannot Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Therapeutic Intervention
n=17 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=93 Participants
|
|
Age Continuous
|
60 years
STANDARD_DEVIATION 1 • n=93 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: On study date to off study date in this study with median 9.76 monthsNumber of days from study enrollment to evidence of progressive disease radiographically, with progression defined under RECIST criteria as at least 20% increase in sum of longest diameter of target lesions
Outcome measures
| Measure |
Therapeutic Intervention
n=17 Participants
|
|---|---|
|
Progression-free Survival (PFS)
|
55 Days
Interval 10.0 to 295.0
|
SECONDARY outcome
Timeframe: On study date to off study date in this study with median 9.76 monthsNumber of patients in each response category according to RECIST criteria: Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
Outcome measures
| Measure |
Therapeutic Intervention
n=17 Participants
|
|---|---|
|
Patient Response to Treatment
Partial Response
|
2 participants
|
|
Patient Response to Treatment
Progressive Disease
|
7 participants
|
|
Patient Response to Treatment
Stable Disease
|
4 participants
|
|
Patient Response to Treatment
Unknown
|
4 participants
|
SECONDARY outcome
Timeframe: On study date to off study date in this study with median 9.76 monthsMedian survival time in months, from on-study date to date of death
Outcome measures
| Measure |
Therapeutic Intervention
n=17 Participants
|
|---|---|
|
Overall Survival
|
8.54 Months
Interval 5.58 to 10.74
|
SECONDARY outcome
Timeframe: 1 year from on-study datePercent of patients who remain alive one year from on-study date
Outcome measures
| Measure |
Therapeutic Intervention
n=17 Participants
|
|---|---|
|
One Year Survival Rate
|
17.6 Percentage of participants
Interval 6.32 to 49.3
|
SECONDARY outcome
Timeframe: On study date to off study date in this study with median 9.76 monthsNumber of patients with worst-grade toxicity response of each grade (grade 1 to 5) following NCI Common Toxicity Criteria, with grade 1=mild adverse event; 2=moderate adverse event; 3=severe and undesirable adverse event; 4=life-threatening or disabling adverse event; 5=death.
Outcome measures
| Measure |
Therapeutic Intervention
n=17 Participants
|
|---|---|
|
Number of Patients With Each Worst-grade Toxicity Response
No. of patients with worst-grade toxicity of 1
|
0 patients
|
|
Number of Patients With Each Worst-grade Toxicity Response
No. of patients with worst-grade toxicity of 2
|
0 patients
|
|
Number of Patients With Each Worst-grade Toxicity Response
No. of patients with worst-grade toxicity of 3
|
1 patients
|
|
Number of Patients With Each Worst-grade Toxicity Response
No. of patients with worst-grade toxicity of 4
|
1 patients
|
|
Number of Patients With Each Worst-grade Toxicity Response
No. of patients with worst-grade toxicity of 5
|
0 patients
|
SECONDARY outcome
Timeframe: on-study week 5Measurement in ng/mL of a stable metabolite of prostaglandin E2 (PGE-M) in urine during treatment cycle 1
Outcome measures
| Measure |
Therapeutic Intervention
n=17 Participants
|
|---|---|
|
Urinary PGE-M : Treatment Cycle 1
Stable or PR (n=6)
|
30.42 ng/mL
Standard Deviation 17.15
|
|
Urinary PGE-M : Treatment Cycle 1
Progressive Disease (n=11)
|
21.94 ng/mL
Standard Deviation 17.13
|
SECONDARY outcome
Timeframe: on-study week 5Measurement in ng/mL of tumor growth factor-alpha (TGF-alpha) in serum samples during treatment cycle 1
Outcome measures
| Measure |
Therapeutic Intervention
n=17 Participants
|
|---|---|
|
Serum TGF-alpha: Treatment Cycle 1
Stable or PR (n=5)
|
26.38 ng/mL
Standard Deviation 17.15
|
|
Serum TGF-alpha: Treatment Cycle 1
Progressive Disease (n=10)
|
25.90 ng/mL
Standard Deviation 10.93
|
SECONDARY outcome
Timeframe: on-study week 9Measurement in ng/mL of a stable metabolite of prostaglandin E2 (PGE-M) in urine during treatment cycle 2
Outcome measures
| Measure |
Therapeutic Intervention
n=17 Participants
|
|---|---|
|
Urinary PGE-M : Treatment Cycle 2
Stable or PR (n=6)
|
28.42 ng/mL
Standard Deviation 25.73
|
|
Urinary PGE-M : Treatment Cycle 2
Progressive Disease (n=4)
|
29.76 ng/mL
Standard Deviation 41.34
|
SECONDARY outcome
Timeframe: on-study week 9Measurement in ng/mL of tumor growth factor-alpha (TGF-alpha) in serum samples during treatment cycle 2
Outcome measures
| Measure |
Therapeutic Intervention
n=17 Participants
|
|---|---|
|
Serum TGF-alpha: Treatment Cycle 2
Stable or PR (n=6)
|
48.02 ng/mL
Standard Deviation 16.94
|
|
Serum TGF-alpha: Treatment Cycle 2
Progressive Disease (n=4)
|
49.95 ng/mL
Standard Deviation 27.27
|
Adverse Events
Therapeutic Intervention
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Therapeutic Intervention
n=17 participants at risk
|
|---|---|
|
Renal and urinary disorders
Hemorrhage, bladder
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
neurology, brain mets
|
5.9%
1/17 • Number of events 1
|
Other adverse events
| Measure |
Therapeutic Intervention
n=17 participants at risk
|
|---|---|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
11.8%
2/17 • Number of events 2
|
|
Investigations
alkaline phosphatase
|
23.5%
4/17 • Number of events 5
|
|
General disorders
allergic reaction
|
17.6%
3/17 • Number of events 3
|
|
Metabolism and nutrition disorders
ALT, SGPT
|
11.8%
2/17 • Number of events 2
|
|
Psychiatric disorders
anorexia
|
23.5%
4/17 • Number of events 4
|
|
Blood and lymphatic system disorders
AST, SGOT
|
17.6%
3/17 • Number of events 3
|
|
Metabolism and nutrition disorders
hyperbilirubinemia
|
17.6%
3/17 • Number of events 3
|
|
Metabolism and nutrition disorders
hypocalcemia
|
17.6%
3/17 • Number of events 4
|
|
General disorders
edema
|
11.8%
2/17 • Number of events 3
|
|
Eye disorders
cataract
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
constipation
|
23.5%
4/17 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
23.5%
4/17 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
dermatologic general
|
41.2%
7/17 • Number of events 8
|
|
Gastrointestinal disorders
diarrhea
|
41.2%
7/17 • Number of events 8
|
|
Nervous system disorders
dizziness
|
11.8%
2/17 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
17.6%
3/17 • Number of events 4
|
|
General disorders
fatigue
|
70.6%
12/17 • Number of events 13
|
|
Gastrointestinal disorders
dyspepsi
|
17.6%
3/17 • Number of events 3
|
|
Investigations
hemoglobin
|
41.2%
7/17 • Number of events 11
|
|
Gastrointestinal disorders
hemorrhage, rectum
|
17.6%
3/17 • Number of events 3
|
|
Renal and urinary disorders
hemorrhage, bladder
|
23.5%
4/17 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
hemorrhage, pulmonary
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
hemorrhoids
|
5.9%
1/17 • Number of events 1
|
|
Vascular disorders
hot flashes
|
5.9%
1/17 • Number of events 1
|
|
Vascular disorders
hypotension
|
5.9%
1/17 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
hiccoughs
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
anal incontinence
|
5.9%
1/17 • Number of events 1
|
|
Infections and infestations
infection
|
17.6%
3/17 • Number of events 3
|
|
Infections and infestations
infection with normal ANC
|
5.9%
1/17 • Number of events 1
|
|
Psychiatric disorders
insomnia
|
23.5%
4/17 • Number of events 4
|
|
Blood and lymphatic system disorders
leukocytes
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
hypomagnesiumia
|
35.3%
6/17 • Number of events 6
|
|
Metabolism and nutrition disorders
hypercholesterolemia
|
5.9%
1/17 • Number of events 1
|
|
Psychiatric disorders
agitation
|
11.8%
2/17 • Number of events 2
|
|
Psychiatric disorders
depression
|
11.8%
2/17 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
muscle weakness
|
11.8%
2/17 • Number of events 2
|
|
Gastrointestinal disorders
reflux
|
11.8%
2/17 • Number of events 2
|
|
Metabolism and nutrition disorders
hyperglycemia
|
23.5%
4/17 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
nail changes
|
11.8%
2/17 • Number of events 3
|
|
Nervous system disorders
restless leg
|
11.8%
2/17 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
balanitis
|
11.8%
2/17 • Number of events 2
|
|
Nervous system disorders
peripheral neuropathy
|
29.4%
5/17 • Number of events 5
|
|
Eye disorders
eye irritation
|
11.8%
2/17 • Number of events 3
|
|
Gastrointestinal disorders
pain, abdominal
|
47.1%
8/17 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
pain, back
|
17.6%
3/17 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
pain, extremity
|
5.9%
1/17 • Number of events 1
|
|
Nervous system disorders
pain, head
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
pain, muscle
|
5.9%
1/17 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
pain, rib cage
|
11.8%
2/17 • Number of events 2
|
|
Gastrointestinal disorders
pain, rectum
|
11.8%
2/17 • Number of events 2
|
|
Investigations
platelets
|
11.8%
2/17 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
pruritus, itching
|
29.4%
5/17 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
rash, desquamation
|
88.2%
15/17 • Number of events 20
|
|
Skin and subcutaneous tissue disorders
hand, foot rash
|
5.9%
1/17 • Number of events 1
|
|
Metabolism and nutrition disorders
hypokalemia
|
29.4%
5/17 • Number of events 5
|
|
Renal and urinary disorders
urinary frequency
|
11.8%
2/17 • Number of events 2
|
|
Renal and urinary disorders
urinary retention
|
11.8%
2/17 • Number of events 2
|
|
Metabolism and nutrition disorders
hyponatremia
|
5.9%
1/17 • Number of events 1
|
|
Vascular disorders
diaphoresis, sweating
|
11.8%
2/17 • Number of events 2
|
|
Nervous system disorders
tremor
|
5.9%
1/17 • Number of events 1
|
|
Gastrointestinal disorders
vomiting
|
5.9%
1/17 • Number of events 1
|
|
Reproductive system and breast disorders
vaginal discharge
|
5.9%
1/17 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
hoarseness
|
5.9%
1/17 • Number of events 1
|
|
Eye disorders
blurred vision
|
11.8%
2/17 • Number of events 2
|
|
Gastrointestinal disorders
flatulence
|
5.9%
1/17 • Number of events 1
|
|
General disorders
fever
|
11.8%
2/17 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place