Trial Outcomes & Findings for Docetaxel, Cisplatin, and Cetuximab (TPC) in Palliative Treatment of Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN) (NCT NCT01437449)
NCT ID: NCT01437449
Last Updated: 2024-01-30
Results Overview
Clinical response for each participant will be assessed after 8 weeks of treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Overall response rate (ORR) was assessed as the sum of the number of participants that experience a complete response (CR) or partial response (PR). The outcome is defined and reported as the number of subjects that responded, a number without dispersion. Other response statuses are included. RECIST v1.1 criteria is defined as follows. * Complete Response (CR) = Disappearance of all target lesions * Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions * Overall Response (OR) = CR + PR * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) * Stable disease (SD) = Small changes that do not meet any of the above criteria
COMPLETED
PHASE2
27 participants
8 weeks
2024-01-30
Participant Flow
Participant milestones
| Measure |
Cisplatin + Docetaxel + Cetuximab
Patients will be treated weekly with cisplatin, docetaxel, and cetuximab.
Docetaxel: 30 mg/m² by intravenous (IV) administration
Cisplatin: 30 mg/m² by intravenous (IV) administration
Cetuximab: 400 mg/m² by intravenous (IV) administration, thereafter 250 IV
Carboplatin: Area under the free carboplatin plasma concentration versus time curve (AUC)=2 by intravenous (IV) administration
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Docetaxel, Cisplatin, and Cetuximab (TPC) in Palliative Treatment of Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Baseline characteristics by cohort
| Measure |
Cisplatin + Docetaxel + Cetuximab
n=27 Participants
Patients will be treated weekly with cisplatin, docetaxel, and cetuximab.
Docetaxel: 30 mg/m² by intravenous (IV) administration
Cisplatin: 30 mg/m² by intravenous (IV) administration
Cetuximab: 400 mg/m² by intravenous (IV) administration, thereafter 250 IV
Carboplatin: Area under the free carboplatin plasma concentration versus time curve (AUC)=2 by intravenous (IV) administration
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=99 Participants
|
|
Age, Continuous
|
57.1 years
STANDARD_DEVIATION 14.0 • n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Response data were not available for all participants.
Clinical response for each participant will be assessed after 8 weeks of treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Overall response rate (ORR) was assessed as the sum of the number of participants that experience a complete response (CR) or partial response (PR). The outcome is defined and reported as the number of subjects that responded, a number without dispersion. Other response statuses are included. RECIST v1.1 criteria is defined as follows. * Complete Response (CR) = Disappearance of all target lesions * Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions * Overall Response (OR) = CR + PR * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) * Stable disease (SD) = Small changes that do not meet any of the above criteria
Outcome measures
| Measure |
Cisplatin + Docetaxel + Cetuximab
n=26 Participants
Patients will be treated weekly with cisplatin, docetaxel, and cetuximab.
Docetaxel: 30 mg/m² by intravenous (IV) administration
Cisplatin: 30 mg/m² by intravenous (IV) administration
Cetuximab: 400 mg/m² by intravenous (IV) administration, thereafter 250 IV
Carboplatin: Area under the free carboplatin plasma concentration versus time curve (AUC)=2 by intravenous (IV) administration
|
|---|---|
|
Overall Response Rate (ORR)
Complete Response (CR)
|
1 participants
|
|
Overall Response Rate (ORR)
Partial Response (PR)
|
14 participants
|
|
Overall Response Rate (ORR)
Overall Response (OR)
|
15 participants
|
|
Overall Response Rate (ORR)
Stable disease (SD)
|
5 participants
|
|
Overall Response Rate (ORR)
Progressive disease (PD)
|
6 participants
|
SECONDARY outcome
Timeframe: 24 monthsProgression-free survival (PFS), defined as the duration of time from start of treatment to time of progression or death, was assessed through 24 months, according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. The outcome is reported as the median time that participants remained free of progression, with 95% confidence interval (CI). * Complete Response (CR) = Disappearance of all target lesions * Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions * Overall Response (OR) = CR + PR * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) * Stable disease (SD) = Small changes that do not meet any of the above criteria
Outcome measures
| Measure |
Cisplatin + Docetaxel + Cetuximab
n=27 Participants
Patients will be treated weekly with cisplatin, docetaxel, and cetuximab.
Docetaxel: 30 mg/m² by intravenous (IV) administration
Cisplatin: 30 mg/m² by intravenous (IV) administration
Cetuximab: 400 mg/m² by intravenous (IV) administration, thereafter 250 IV
Carboplatin: Area under the free carboplatin plasma concentration versus time curve (AUC)=2 by intravenous (IV) administration
|
|---|---|
|
Progression-free Survival (PFS)
|
4.8 months
Interval 2.7 to 6.6
|
SECONDARY outcome
Timeframe: 24 monthsOverall survival (OS) was assessed through 24 months. The outcome is reported as the median time that participants remained alive, with 95% CI.
Outcome measures
| Measure |
Cisplatin + Docetaxel + Cetuximab
n=27 Participants
Patients will be treated weekly with cisplatin, docetaxel, and cetuximab.
Docetaxel: 30 mg/m² by intravenous (IV) administration
Cisplatin: 30 mg/m² by intravenous (IV) administration
Cetuximab: 400 mg/m² by intravenous (IV) administration, thereafter 250 IV
Carboplatin: Area under the free carboplatin plasma concentration versus time curve (AUC)=2 by intravenous (IV) administration
|
|---|---|
|
Overall Survival (OS)
|
14.7 months
Interval 8.3 to
The upper limit of the 95% confidence interval has not been reached.
|
SECONDARY outcome
Timeframe: 2 yearsRelated adverse events are considered toxicities. The outcome was assessed as adverse events and serious adverse events (SAEs per 21CFR§312.32) at least Grade 3, and are reported as the number of toxicities by grade (3, 4 or 5), a number without dispersion.
Outcome measures
| Measure |
Cisplatin + Docetaxel + Cetuximab
n=27 Participants
Patients will be treated weekly with cisplatin, docetaxel, and cetuximab.
Docetaxel: 30 mg/m² by intravenous (IV) administration
Cisplatin: 30 mg/m² by intravenous (IV) administration
Cetuximab: 400 mg/m² by intravenous (IV) administration, thereafter 250 IV
Carboplatin: Area under the free carboplatin plasma concentration versus time curve (AUC)=2 by intravenous (IV) administration
|
|---|---|
|
Grade 3, 4, and 5 Related Adverse Events (Toxicities)
|
24 Related Adverse Events
|
Adverse Events
Cisplatin + Docetaxel + Cetuximab
Serious adverse events
| Measure |
Cisplatin + Docetaxel + Cetuximab
n=27 participants at risk
Patients will be treated weekly with cisplatin, docetaxel, and cetuximab.
Docetaxel: 30 mg/m² by intravenous (IV) administration
Cisplatin: 30 mg/m² by intravenous (IV) administration
Cetuximab: 400 mg/m² by intravenous (IV) administration, thereafter 250 IV
Carboplatin: Area under the free carboplatin plasma concentration versus time curve (AUC)=2 by intravenous (IV) administration
|
|---|---|
|
Gastrointestinal disorders
Colitis
|
3.7%
1/27 • Number of events 4 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Oral cavity infection
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Pneumoperitoneum,Pneumoperitoneum
|
3.7%
1/27 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
7.4%
2/27 • Number of events 3 • 2 years
|
|
General disorders
Facial pain
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Infections and infestations
Catheter related infection
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Infections and infestations
Infections and infestations - Other, Abdominal wall infection associated with G-Tube- Recovering
|
3.7%
1/27 • Number of events 2 • 2 years
|
|
Infections and infestations
Sepsis
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Infections and infestations
Sinusitis
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
7.4%
2/27 • Number of events 2 • 2 years
|
|
Investigations
Alkaline phosphatase increased
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
7.4%
2/27 • Number of events 2 • 2 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, Failure to thrive
|
7.4%
2/27 • Number of events 3 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
3.7%
1/27 • Number of events 2 • 2 years
|
|
Nervous system disorders
Nervous system disorders - Other, Neurological deficit
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Nervous system disorders
Stroke
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Nervous system disorders
Syncope
|
7.4%
2/27 • Number of events 2 • 2 years
|
|
Renal and urinary disorders
Acute kidney injury
|
3.7%
1/27 • Number of events 3 • 2 years
|
|
Renal and urinary disorders
Bladder perforation
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other,Penile pain
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, Complicated urinary tract infection (UTI)
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration/Pneumonia
|
7.4%
2/27 • Number of events 3 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.7%
1/27 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, Air obstruction
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, CAP (pneumonia)
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Right hand abscess
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, G-Tube fell out & replacement
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Vascular disorders
Hypotension
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Vascular disorders
Thromboembolic event
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
General disorders
Death NOS
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant. and unspecified (incl cysts and polyps) - Other, disease progression
|
37.0%
10/27 • Number of events 10 • 2 years
|
Other adverse events
| Measure |
Cisplatin + Docetaxel + Cetuximab
n=27 participants at risk
Patients will be treated weekly with cisplatin, docetaxel, and cetuximab.
Docetaxel: 30 mg/m² by intravenous (IV) administration
Cisplatin: 30 mg/m² by intravenous (IV) administration
Cetuximab: 400 mg/m² by intravenous (IV) administration, thereafter 250 IV
Carboplatin: Area under the free carboplatin plasma concentration versus time curve (AUC)=2 by intravenous (IV) administration
|
|---|---|
|
Investigations
Lymphocyte count decreased
|
70.4%
19/27 • Number of events 104 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
7.4%
2/27 • Number of events 2 • 2 years
|
|
Vascular disorders
Hypertension
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
7.4%
2/27 • Number of events 3 • 2 years
|
|
Infections and infestations
Abdominal infection
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Investigations
White blood cell decreased
|
14.8%
4/27 • Number of events 5 • 2 years
|
|
Nervous system disorders
Syncope
|
3.7%
1/27 • Number of events 2 • 2 years
|
|
Investigations
Alkaline phosphatase increase
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Investigations
Aspartate aminotransferase increase
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Investigations
Alanine aminotransferase increase
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
7.4%
2/27 • Number of events 2 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
22.2%
6/27 • Number of events 16 • 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
11.1%
3/27 • Number of events 3 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders -Other, mouth sores
|
3.7%
1/27 • Number of events 2 • 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.4%
2/27 • Number of events 2 • 2 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
7.4%
2/27 • Number of events 4 • 2 years
|
|
Eye disorders
Blurred vision
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
General disorders
Fatigue
|
14.8%
4/27 • Number of events 7 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
2/27 • Number of events 5 • 2 years
|
|
Nervous system disorders
Dizziness
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.7%
1/27 • Number of events 3 • 2 years
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
3.7%
1/27 • Number of events 3 • 2 years
|
|
Nervous system disorders
Neuropathy
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Investigations
INR increased
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Infections and infestations
Sepsis
|
7.4%
2/27 • Number of events 2 • 2 years
|
|
Investigations
Hypocalcemia
|
3.7%
1/27 • Number of events 2 • 2 years
|
|
Infections and infestations
Catheter related infection
|
3.7%
1/27 • Number of events 2 • 2 years
|
|
General disorders
Pain
|
7.4%
2/27 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Colitis
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Acute Kidney injury
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
11.1%
3/27 • Number of events 3 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders, others, hemoptysis
|
3.7%
1/27 • Number of events 5 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.7%
1/27 • Number of events 2 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
General disorders
General disorders and administration site conditions, others- failure to thrive
|
3.7%
1/27 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Oral pain
|
3.7%
1/27 • Number of events 1 • 2 years
|
Additional Information
Dr. A. Dimitrios Colevas, Professor of Medicine (Oncology)
Stanford University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place