Trial Outcomes & Findings for Trial of Cetuximab in Patients With Metastatic and/or Locally Advanced Soft Tissue and Bony Sarcomas (NCT NCT00148109)
NCT ID: NCT00148109
Last Updated: 2013-01-24
Results Overview
Time of cetuximab administration to clinically documented progression of disease or death assessed for four months after starting cetuximab therapy
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
4 months
Results posted on
2013-01-24
Participant Flow
36 subjects were recruited between June of 2005 and June of 2008 in the Comprehensive Cancer Center outpatient Oncology Clinics at the University of Michigan Health Systems
Potential participants who appeared to meet study criteria were approached with a brief discussion of the study. If interested, a more in - depth detail discussion of the risks and benefits of potentially participating in the study took place with the subject as well as any family members that may have been present.
Participant milestones
| Measure |
Epidermal Growth Factor Receptor Negative
Sarcoma does not express Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
|
Epidermal Growth Factor Receptor Positive
Sarcoma expresses Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
21
|
|
Overall Study
COMPLETED
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
12
|
20
|
Reasons for withdrawal
| Measure |
Epidermal Growth Factor Receptor Negative
Sarcoma does not express Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
|
Epidermal Growth Factor Receptor Positive
Sarcoma expresses Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
10
|
18
|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Trial of Cetuximab in Patients With Metastatic and/or Locally Advanced Soft Tissue and Bony Sarcomas
Baseline characteristics by cohort
| Measure |
Epidermal Growth Factor Receptor Negative
n=15 Participants
Sarcoma does not express Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
|
Epidermal Growth Factor Receptor Positive
n=21 Participants
Sarcoma expresses Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age Continuous
|
49 years
FULL_RANGE 2 • n=5 Participants
|
54 years
FULL_RANGE 2 • n=7 Participants
|
54 years
FULL_RANGE 2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
21 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: per protocol all patients that received drug were evaluated for the primary endpoint
Time of cetuximab administration to clinically documented progression of disease or death assessed for four months after starting cetuximab therapy
Outcome measures
| Measure |
Epidermal Growth Factor Receptor Negative
n=15 Participants
Tumor did not express epidermal growth factor receptor
|
Epidermal Growth Factor Receptor Positive
n=21 Participants
Tumor did express epidermal growth factor receptor
|
|---|---|---|
|
Number of Patients With Sarcoma Who Are Tumor Progression Free and Alive at Four Months From Start of Treatment With Single-agent Cetuximab.
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: survivalTime of cetuximab administration to clinically documented progression of disease or death assessed for four months
Outcome measures
| Measure |
Epidermal Growth Factor Receptor Negative
n=15 Participants
Tumor did not express epidermal growth factor receptor
|
Epidermal Growth Factor Receptor Positive
n=21 Participants
Tumor did express epidermal growth factor receptor
|
|---|---|---|
|
Progression Free Survival.
|
1.8 months
Interval 0.8 to 2.5
|
1.7 months
Interval 1.6 to 1.8
|
SECONDARY outcome
Timeframe: monthsTime of cetuximab administration to clinically documented death assessed for four months
Outcome measures
| Measure |
Epidermal Growth Factor Receptor Negative
n=15 Participants
Tumor did not express epidermal growth factor receptor
|
Epidermal Growth Factor Receptor Positive
n=21 Participants
Tumor did express epidermal growth factor receptor
|
|---|---|---|
|
Overall Survival
|
15.7 months
Interval 7.7 to 25.3
|
7.7 months
Interval 4.2 to 10.7
|
Adverse Events
Epidermal Growth Factor Receptor Negative
Serious events: 9 serious events
Other events: 10 other events
Deaths: 0 deaths
Epidermal Growth Factor Receptor Positive
Serious events: 10 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Epidermal Growth Factor Receptor Negative
n=15 participants at risk
Sarcoma does not express Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
|
Epidermal Growth Factor Receptor Positive
n=21 participants at risk
Sarcoma expresses Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
|
|---|---|---|
|
Nervous system disorders
spinal cord compression
|
0.00%
0/15
|
4.8%
1/21 • Number of events 1
|
|
Nervous system disorders
Acute Neurological Symptoms
|
0.00%
0/15
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
6.7%
1/15 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death due to disease progression
|
13.3%
2/15 • Number of events 2
|
9.5%
2/21 • Number of events 2
|
|
Infections and infestations
Bacterial meningitis
|
0.00%
0/15
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pressure and Shortness of Breath
|
0.00%
0/15
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Lower GI Bleed
|
0.00%
0/15
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Hip Fracture
|
6.7%
1/15 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Upper GI Bleed
|
6.7%
1/15 • Number of events 1
|
0.00%
0/21
|
|
Renal and urinary disorders
Renal Failure
|
6.7%
1/15 • Number of events 1
|
0.00%
0/21
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
1/15 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
intestinal ileus
|
0.00%
0/15
|
4.8%
1/21 • Number of events 1
|
|
Vascular disorders
Atrial Fibrillation
|
6.7%
1/15 • Number of events 1
|
0.00%
0/21
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/15
|
4.8%
1/21 • Number of events 1
|
|
Vascular disorders
Vertigo
|
0.00%
0/15
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
6.7%
1/15 • Number of events 1
|
0.00%
0/21
|
Other adverse events
| Measure |
Epidermal Growth Factor Receptor Negative
n=15 participants at risk
Sarcoma does not express Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
|
Epidermal Growth Factor Receptor Positive
n=21 participants at risk
Sarcoma expresses Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
10/15 • Number of events 10
|
52.4%
11/21 • Number of events 11
|
|
Gastrointestinal disorders
Nausea/vomiting
|
20.0%
3/15 • Number of events 3
|
14.3%
3/21 • Number of events 3
|
|
General disorders
Fatigue
|
40.0%
6/15 • Number of events 6
|
4.8%
1/21 • Number of events 1
|
|
Renal and urinary disorders
renal failure
|
6.7%
1/15 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
|
Injury, poisoning and procedural complications
infusion reaction
|
13.3%
2/15 • Number of events 2
|
4.8%
1/21 • Number of events 1
|
Additional Information
Dr. Rashmi Chugh
University of Michigan Comprehensive Cancer Center
Phone: (734) 936-5710
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place