Trial Outcomes & Findings for Study of Cetuximab With and Without Weekly Paclitaxel for Patients With Previously Treated Advanced Urothelial Cancer (NCT NCT00350025)
NCT ID: NCT00350025
Last Updated: 2017-03-31
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Measures by CT scans following each 2 cycles of treatment and about every 8 weeks after off treatment for disease progression. Follow up for survival until time of death.
Results posted on
2017-03-31
Participant Flow
Participant milestones
| Measure |
Arm A - Cetuximab Treatment Arm
Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy
Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.
|
Arm B Paclitaxel and Cetuximab Combination Treatment Arm
Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.
Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.
Paclitaxel: Paclitaxel 80mg/m2 IV weekly for each 28 day cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
30
|
|
Overall Study
COMPLETED
|
11
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Cetuximab With and Without Weekly Paclitaxel for Patients With Previously Treated Advanced Urothelial Cancer
Baseline characteristics by cohort
| Measure |
Arm A - Cetuximab Treatment Arm
n=11 Participants
Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy
Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.
|
Arm B Paclitaxel and Cetuximab Combination Treatment Arm
n=28 Participants
Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.
Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.
Paclitaxel: Paclitaxel 80mg/m2 IV weekly for each 28 day cycle.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
n=5 Participants
|
69 years
n=7 Participants
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Performance Status
0-1
|
11 participants
n=5 Participants
|
25 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Performance Status
2
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Primary site, No. of patients
Bladder
|
9 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Primary site, No. of patients
Renal Pelvis
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Previous Chemotherapy, No. of Patients
Gemcitabine and Platinum
|
11 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Previous Chemotherapy, No. of Patients
MVAC
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measures by CT scans following each 2 cycles of treatment and about every 8 weeks after off treatment for disease progression. Follow up for survival until time of death.Outcome measures
| Measure |
Arm A - Cetuximab Treatment Arm
n=11 Participants
Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy
Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.
|
Arm B Paclitaxel and Cetuximab Combination Treatment Arm
n=28 Participants
Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.
Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.
Paclitaxel: Paclitaxel 80mg/m2 IV weekly for each 28 day cycle.
|
|---|---|---|
|
Progression Free Survival
|
7.6 weeks
Interval 6.0 to
The single agent cetuximab arm was closed for futility
|
16.4 weeks
Interval 12.0 to 25.1
|
SECONDARY outcome
Timeframe: Measured by CT scans after every 2 cycles of treatment (about every 8 weeks)Population: Overall Survival
Outcome measures
| Measure |
Arm A - Cetuximab Treatment Arm
n=11 Participants
Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy
Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.
|
Arm B Paclitaxel and Cetuximab Combination Treatment Arm
n=28 Participants
Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.
Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.
Paclitaxel: Paclitaxel 80mg/m2 IV weekly for each 28 day cycle.
|
|---|---|---|
|
Response Rate, Duration of Response, Time to Progression Will be Assessed With Radiographic Imaging
Overall Survival
|
17 weeks
Interval 14.3 to
The single-agent cetuximab arm was closed for futility
|
42 weeks
Interval 30.4 to 78.0
|
|
Response Rate, Duration of Response, Time to Progression Will be Assessed With Radiographic Imaging
Overall Response Rate
|
NA weeks
The single-agent cetuximab arm was closed for futility
|
25 weeks
Interval 11.0 to 45.0
|
Adverse Events
Arm A - Cetuximab Treatment Arm
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
Arm B Paclitaxel and Cetuximab Combination Treatment Arm
Serious events: 15 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A - Cetuximab Treatment Arm
n=11 participants at risk
Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy
Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.
|
Arm B Paclitaxel and Cetuximab Combination Treatment Arm
n=28 participants at risk
Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.
Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.
Paclitaxel: Paclitaxel 80mg/m2 IV weekly for each 28 day cycle.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypercalcemia
|
9.1%
1/11
|
0.00%
0/28
|
|
Gastrointestinal disorders
Fever
|
9.1%
1/11
|
0.00%
0/28
|
|
General disorders
death
|
18.2%
2/11
|
7.1%
2/28
|
|
Reproductive system and breast disorders
Urinary tract obstruction
|
0.00%
0/11
|
3.6%
1/28
|
|
Renal and urinary disorders
acute renal faliure
|
0.00%
0/11
|
3.6%
1/28
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
18.2%
2/11
|
3.6%
1/28
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
9.1%
1/11
|
3.6%
1/28
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/11
|
7.1%
2/28
|
|
Renal and urinary disorders
urinary retention
|
0.00%
0/11
|
7.1%
2/28
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11
|
3.6%
1/28
|
|
Cardiac disorders
congestive heart faliure
|
0.00%
0/11
|
3.6%
1/28
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
9.1%
1/11
|
0.00%
0/28
|
|
General disorders
Gait disturbance
|
0.00%
0/11
|
3.6%
1/28
|
|
General disorders
Infusion reaction
|
0.00%
0/11
|
3.6%
1/28
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/11
|
3.6%
1/28
|
|
Hepatobiliary disorders
hepatic faliure
|
0.00%
0/11
|
3.6%
1/28
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/11
|
10.7%
3/28
|
|
Metabolism and nutrition disorders
dehydration
|
0.00%
0/11
|
3.6%
1/28
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/11
|
10.7%
3/28
|
|
Injury, poisoning and procedural complications
urosepsis
|
0.00%
0/11
|
3.6%
1/28
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11
|
7.1%
2/28
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/11
|
10.7%
3/28
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/11
|
3.6%
1/28
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
0.00%
0/11
|
3.6%
1/28
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/11
|
0.00%
0/28
|
|
Immune system disorders
Rash
|
0.00%
0/11
|
3.6%
1/28
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/11
|
3.6%
1/28
|
Other adverse events
| Measure |
Arm A - Cetuximab Treatment Arm
n=11 participants at risk
Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy
Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.
|
Arm B Paclitaxel and Cetuximab Combination Treatment Arm
n=28 participants at risk
Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.
Cetuximab: Cetuximab 250mg/m2 IV weekly for each 28 day cycle.
Paclitaxel: Paclitaxel 80mg/m2 IV weekly for each 28 day cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
90.9%
10/11
|
89.3%
25/28
|
|
Blood and lymphatic system disorders
ANC
|
9.1%
1/11
|
42.9%
12/28
|
|
Blood and lymphatic system disorders
Platelets
|
0.00%
0/11
|
10.7%
3/28
|
|
Blood and lymphatic system disorders
Leukocytes
|
27.3%
3/11
|
71.4%
20/28
|
|
Blood and lymphatic system disorders
Edema
|
18.2%
2/11
|
42.9%
12/28
|
|
Vascular disorders
DVT
|
0.00%
0/11
|
7.1%
2/28
|
|
Cardiac disorders
Hypertension
|
54.5%
6/11
|
35.7%
10/28
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11
|
28.6%
8/28
|
|
General disorders
fever
|
18.2%
2/11
|
17.9%
5/28
|
|
General disorders
fatigue
|
72.7%
8/11
|
96.4%
27/28
|
|
General disorders
chills
|
18.2%
2/11
|
28.6%
8/28
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.2%
2/11
|
57.1%
16/28
|
|
Skin and subcutaneous tissue disorders
Nail Loss
|
0.00%
0/11
|
14.3%
4/28
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
18.2%
2/11
|
17.9%
5/28
|
|
Skin and subcutaneous tissue disorders
Rash
|
90.9%
10/11
|
96.4%
27/28
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
36.4%
4/11
|
39.3%
11/28
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
45.5%
5/11
|
35.7%
10/28
|
|
Gastrointestinal disorders
Hemorrhage
|
9.1%
1/11
|
39.3%
11/28
|
|
Gastrointestinal disorders
vomiting
|
18.2%
2/11
|
25.0%
7/28
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/11
|
7.1%
2/28
|
|
Gastrointestinal disorders
Dyspepsia
|
36.4%
4/11
|
17.9%
5/28
|
|
Gastrointestinal disorders
Constipation
|
72.7%
8/11
|
60.7%
17/28
|
|
Gastrointestinal disorders
Diarrhea
|
27.3%
3/11
|
42.9%
12/28
|
|
Investigations
Weight loss
|
9.1%
1/11
|
14.3%
4/28
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/11
|
3.6%
1/28
|
|
Psychiatric disorders
confusion
|
9.1%
1/11
|
3.6%
1/28
|
|
Psychiatric disorders
Insomnia
|
9.1%
1/11
|
39.3%
11/28
|
|
Nervous system disorders
Depression
|
9.1%
1/11
|
25.0%
7/28
|
|
Nervous system disorders
Neuropathy-motor
|
9.1%
1/11
|
10.7%
3/28
|
|
Nervous system disorders
Neuropathy - sensory
|
36.4%
4/11
|
39.3%
11/28
|
|
Nervous system disorders
Paresthesia
|
36.4%
4/11
|
35.7%
10/28
|
|
Psychiatric disorders
Restlessness
|
9.1%
1/11
|
0.00%
0/28
|
|
Eye disorders
Blurred vision
|
0.00%
0/11
|
7.1%
2/28
|
|
General disorders
Headache
|
27.3%
3/11
|
21.4%
6/28
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
36.4%
4/11
|
35.7%
10/28
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
54.5%
6/11
|
42.9%
12/28
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
54.5%
6/11
|
57.1%
16/28
|
|
Investigations
Alpkaline Phosphatase
|
45.5%
5/11
|
42.9%
12/28
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/11
|
14.3%
4/28
|
|
Metabolism and nutrition disorders
hyperkalemia
|
27.3%
3/11
|
25.0%
7/28
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
63.6%
7/11
|
60.7%
17/28
|
|
Investigations
blood bilirubin increase
|
0.00%
0/11
|
3.6%
1/28
|
|
Investigations
SGOT
|
18.2%
2/11
|
25.0%
7/28
|
|
Investigations
SGPT
|
18.2%
2/11
|
17.9%
5/28
|
|
Hepatobiliary disorders
hepatic faliure
|
0.00%
0/11
|
3.6%
1/28
|
|
Investigations
creatinine
|
54.5%
6/11
|
53.6%
15/28
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
54.5%
6/11
|
82.1%
23/28
|
|
Renal and urinary disorders
Hematuria
|
9.1%
1/11
|
21.4%
6/28
|
|
Infections and infestations
Infection
|
54.5%
6/11
|
53.6%
15/28
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
90.9%
10/11
|
71.4%
20/28
|
|
Metabolism and nutrition disorders
hypercalcemia
|
18.2%
2/11
|
7.1%
2/28
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
9.1%
1/11
|
42.9%
12/28
|
|
Metabolism and nutrition disorders
hyponatremia
|
0.00%
0/11
|
28.6%
8/28
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
1/11
|
14.3%
4/28
|
|
Gastrointestinal disorders
Mucositis
|
9.1%
1/11
|
35.7%
10/28
|
|
Nervous system disorders
Dysgeucia
|
9.1%
1/11
|
28.6%
8/28
|
|
Metabolism and nutrition disorders
Anorexia
|
45.5%
5/11
|
50.0%
14/28
|
|
Gastrointestinal disorders
Nausea
|
36.4%
4/11
|
42.9%
12/28
|
|
Renal and urinary disorders
urinary retention
|
0.00%
0/11
|
3.6%
1/28
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place