Trial Outcomes & Findings for Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil (NCT NCT00400205)
NCT ID: NCT00400205
Last Updated: 2017-11-06
Results Overview
Complete remission (complete disappearance of disease), partial remission \[more than 30% decrease in tumor measurement by RECIST (Response evaluation criteria in solid tumors)\].
TERMINATED
PHASE2
14 participants
every 3 months
2017-11-06
Participant Flow
Accrual period is from Aug 2006 through Jul 2009. Accrual of 14 patients.
A total of 14 patients with squamous carcinoma were enrolled. All patients had stage 4a or 4b disease and had a performance status of 0-2 then all had measurable lesions on imaging. The study closed prematurely due to slow accrual and increased observed complications.
Participant milestones
| Measure |
Recipients of Docetaxel, Cisplatin, 5-Fluorouracil
Participants with squamous cell carcinoma receiving chemotherapy with docetaxel, cisplatin, and 5-fluorouracil
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil
Baseline characteristics by cohort
| Measure |
Recipients of Docetaxel, Cisplatin, 5-Fluorouracil
n=14 Participants
Patients with locally advanced squamous cell carcinoma of the head and neck received three cycles of induction therapy with docetaxel, cisplatin, and 5-fluorouracil followed by local therapy consisting of surgical resection in addition to possible radiation therapy with or without concurrent chemotherapy.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
|
Tumor Stage IV
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: every 3 monthsComplete remission (complete disappearance of disease), partial remission \[more than 30% decrease in tumor measurement by RECIST (Response evaluation criteria in solid tumors)\].
Outcome measures
| Measure |
Recipients of Docetaxel, Cisplatin, 5-Fluorouracil
n=9 Participants
Participants with squamous cell carcinoma receiving chemotherapy with docetaxel, cisplatin, and 5-fluorouracil
|
|---|---|
|
Number of Patients Who Had Response by RECIST Criteria (Response Evaluation Criteria in Solid Tumors)
|
8 participants
|
SECONDARY outcome
Timeframe: Baseline, After 3 cycles of study treatmentPopulation: Participants who completed the study are included in this analysis.
Percent change in TNM stage of tumors after three cycles of study treatment was assessed to see if baseline acetylated tubulin (AT) expression predicts treatment success. Decreasing tumor stage change (a negative number) indicates that the tumor is responding to treatment while an increase means that the severity of the tumor is not decreasing. Immunohistochemistry (IHC) analysis of AT expression was performed in formalin-fixed, paraffin-embedded, pre-treatment tissues. The staining was scored based upon intensity according to the following criteria: 0=no staining, 1+=weak tumor staining, 2+=moderate tumor staining, 3+=moderate to high tumor staining, and 4+=high tumor staining. Data presented are adopted from Saba, NF, et. al. Acetylated Tubulin (AT) as a Prognostic Marker in Squamous Cell Carcinoma of the Head and Neck. Head and Neck Pathology (2014) 8:66-72.
Outcome measures
| Measure |
Recipients of Docetaxel, Cisplatin, 5-Fluorouracil
n=9 Participants
Participants with squamous cell carcinoma receiving chemotherapy with docetaxel, cisplatin, and 5-fluorouracil
|
|---|---|
|
Tumor Change by Baseline Acetylated Tubulin Expression Score
AT score less than or equal to 2
|
-0.8 percentage of tumor stage change
Standard Deviation 0.23
|
|
Tumor Change by Baseline Acetylated Tubulin Expression Score
AT score greater than 2
|
-0.36 percentage of tumor stage change
Standard Deviation 0.44
|
Adverse Events
Recipients of Docetaxel, Cisplatin, 5-Fluorouracil
Serious adverse events
| Measure |
Recipients of Docetaxel, Cisplatin, 5-Fluorouracil
n=14 participants at risk
Patients with locally advanced squamous cell carcinoma of the head and neck received three cycles of induction therapy with docetaxel, cisplatin, and 5-fluorouracil followed by local therapy consisting of surgical resection in addition to possible radiation therapy with or without concurrent chemotherapy.
|
|---|---|
|
Infections and infestations
Death
|
7.1%
1/14 • Number of events 1 • 3 years
|
|
General disorders
Death
|
7.1%
1/14 • Number of events 1 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death
|
7.1%
1/14 • Number of events 1 • 3 years
|
|
Nervous system disorders
Stroke
|
7.1%
1/14 • Number of events 1 • 3 years
|
|
Infections and infestations
Fever neutropenia
|
7.1%
1/14 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
7.1%
1/14 • Number of events 1 • 3 years
|
|
Infections and infestations
PEG tube infection
|
7.1%
1/14 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Recipients of Docetaxel, Cisplatin, 5-Fluorouracil
n=14 participants at risk
Patients with locally advanced squamous cell carcinoma of the head and neck received three cycles of induction therapy with docetaxel, cisplatin, and 5-fluorouracil followed by local therapy consisting of surgical resection in addition to possible radiation therapy with or without concurrent chemotherapy.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
35.7%
5/14 • Number of events 6 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
21.4%
3/14 • Number of events 3 • 3 years
|
|
Psychiatric disorders
Anxiety
|
50.0%
7/14 • Number of events 8 • 3 years
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
50.0%
7/14 • Number of events 9 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
42.9%
6/14 • Number of events 7 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
42.9%
6/14 • Number of events 8 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
50.0%
7/14 • Number of events 7 • 3 years
|
|
Psychiatric disorders
Depression
|
35.7%
5/14 • Number of events 5 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
42.9%
6/14 • Number of events 9 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Difficulty speaking
|
7.1%
1/14 • Number of events 1 • 3 years
|
|
General disorders
Dizziness
|
42.9%
6/14 • Number of events 12 • 3 years
|
|
General disorders
Dry mouth
|
28.6%
4/14 • Number of events 4 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dysphagia
|
57.1%
8/14 • Number of events 10 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Facial pain
|
28.6%
4/14 • Number of events 4 • 3 years
|
|
General disorders
Fatigue
|
85.7%
12/14 • Number of events 23 • 3 years
|
|
General disorders
Fever
|
42.9%
6/14 • Number of events 11 • 3 years
|
|
Gastrointestinal disorders
Heartburn
|
21.4%
3/14 • Number of events 3 • 3 years
|
|
Blood and lymphatic system disorders
Hypokalemia
|
42.9%
6/14 • Number of events 7 • 3 years
|
|
General disorders
Insomnia
|
78.6%
11/14 • Number of events 12 • 3 years
|
|
General disorders
Loss of appetite
|
64.3%
9/14 • Number of events 10 • 3 years
|
|
General disorders
Mouth pain
|
85.7%
12/14 • Number of events 37 • 3 years
|
|
Gastrointestinal disorders
Mucositis
|
71.4%
10/14 • Number of events 21 • 3 years
|
|
General disorders
Nausea
|
64.3%
9/14 • Number of events 13 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
42.9%
6/14 • Number of events 9 • 3 years
|
|
Nervous system disorders
Neuropathy
|
28.6%
4/14 • Number of events 4 • 3 years
|
|
Gastrointestinal disorders
Odynophagia
|
35.7%
5/14 • Number of events 15 • 3 years
|
|
Infections and infestations
Oral thrush
|
50.0%
7/14 • Number of events 7 • 3 years
|
|
Nervous system disorders
Restlessness
|
21.4%
3/14 • Number of events 3 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
21.4%
3/14 • Number of events 4 • 3 years
|
|
Eye disorders
Vision disturbance
|
14.3%
2/14 • Number of events 2 • 3 years
|
|
General disorders
Vomiting
|
35.7%
5/14 • Number of events 5 • 3 years
|
|
General disorders
Weakness
|
50.0%
7/14 • Number of events 8 • 3 years
|
|
General disorders
Weight loss
|
64.3%
9/14 • Number of events 16 • 3 years
|
|
Gastrointestinal disorders
Mouth sores
|
35.7%
5/14 • Number of events 5 • 3 years
|
|
Metabolism and nutrition disorders
Edema
|
42.9%
6/14 • Number of events 8 • 3 years
|
Additional Information
Nabil Saba, MD
Emory University Winship Cancer Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place