Oral Cancer, Squamous Cell Carcinoma
Conditions
Keywords
Squamous Cell Carcinoma of the Oral Cavity
Brief summary
This is a Phase II study designed to test the efficacy of chemotherapy with docetaxel, cisplatinum (cisplatin) and 5-fluorouracil in patients with squamous cell carcinoma of the oral cavity to determine what effects these agents may have on cancer cells.
Detailed description
This is a Phase II study designed to test the efficacy of chemotherapy with docetaxel, cisplatinum, and 5-fluorouracil in patients with squamous cell carcinoma of the oral cavity to determine what effects these agents may have on cancer cells. Approximately 60 patients will take part at multi-sites with potentially 20 patients participating at the Emory Winship Cancer Institute in Atlanta, Georgia.
Interventions
DRUGDocetaxel
Docetaxel 75 mg/m2, intravenous infusion over 1 hour, mixed with normal saline per institutional standard, day 1 and then every 3 weeks.
DRUGCisplatin
Cisplatin 100 mg/m2, intravenous infusion over 30 minutes to 3 hours, day 1 and then every 3 weeks.
DRUG5-fluorouracil
5-fluorouracil 1000 mg/m2/day, 24 hour continuous infusion over 4 days, every 3 weeks.
Sponsors
Sanofi
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically proven squamous cell carcinoma of the oral cavity. * Primary tumor sites eligible: oral cavity. Although they are admittedly of squamous cell types, the following tumors will be excluded because their responsiveness to chemotherapy may differ: tumors of the nasal and paranasal cavities and of the nasopharynx. Oral cavity tumors with mandible invasion are excluded because the tumor biology and management of these tumors is more complex and will likely include upfront surgical resection. * Stage 3 or 4 disease without evidence of distant metastases verified by chest x-ray, abdominal ultrasound, or CT scan (liver function test abnormalities); bone scan in case of local symptoms. * At least one uni- or bi-dimensionally measurable lesion. * Age ≥ 18 years. * World Health Organization (WHO) performance status of 2 or less. * No active alcohol addiction. * Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Exclusion criteria
* Pregnant or breast feeding * Previous malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal, or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years. * Any prior treatment with radiotherapy or chemotherapy is an exclusion criterion. * Patients who experience an involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry. * Concurrent treatment with any other anti-cancer therapy. * Participation in an investigational trial within 30 days of study entry. * Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80. * No previous chemotherapy or radiotherapy for any reason and no previous surgery for SCCHN \[squamous cell carcinoma of the head and neck\] (other than biopsy) are allowed at the time of study entry. * Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Had Response by RECIST Criteria (Response Evaluation Criteria in Solid Tumors) | every 3 months | Complete remission (complete disappearance of disease), partial remission \[more than 30% decrease in tumor measurement by RECIST (Response evaluation criteria in solid tumors)\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Change by Baseline Acetylated Tubulin Expression Score | Baseline, After 3 cycles of study treatment | 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. |
Countries
United States
Participant flow
Recruitment details
Accrual period is from Aug 2006 through Jul 2009. Accrual of 14 patients.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Recipients of Docetaxel, Cisplatin, 5-Fluorouracil 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. | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Recipients of Docetaxel, Cisplatin, 5-Fluorouracil |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 8 Participants |
| Tumor Stage IV | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 14 |
| other Total, other adverse events | 14 / 14 |
| serious Total, serious adverse events | 6 / 14 |
Outcome results
Primary
Number of Patients Who Had Response by RECIST Criteria (Response Evaluation Criteria in Solid Tumors)
Complete remission (complete disappearance of disease), partial remission \[more than 30% decrease in tumor measurement by RECIST (Response evaluation criteria in solid tumors)\].
Time frame: every 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Recipients of Docetaxel, Cisplatin, 5-Fluorouracil | Number of Patients Who Had Response by RECIST Criteria (Response Evaluation Criteria in Solid Tumors) | 8 participants |
Secondary
Tumor Change by Baseline Acetylated Tubulin Expression Score
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.
Time frame: Baseline, After 3 cycles of study treatment
Population: Participants who completed the study are included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Recipients of Docetaxel, Cisplatin, 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 |
| Recipients of Docetaxel, Cisplatin, 5-Fluorouracil | Tumor Change by Baseline Acetylated Tubulin Expression Score | AT score greater than 2 | -0.36 percentage of tumor stage change | Standard Deviation 0.44 |