Carcinoma, Squamous Cell, Head and Neck Cancer
Conditions
Brief summary
The purpose of this study is to determine if combination Erlotinib, Cisplatin/Carboplatin, and Paclitaxel are effective first line treatment for metastatic, recurrent and persistent squamous cell carcinoma of the head and neck.
Detailed description
We hypothesize that Erlotinib fails to enhance the effects of chemotherapy on response and survival because of Erlotinib's cytostatic effect, this results in a slowing down of the cell cycle, this in turn results in a hampering of the cytotoxic effect of chemotherapy leading to a lack of synergism with the combination. We propose that a sequential approach to the combination allows each drug to be used in its optimum time, by sequencing the Erlotinib, giving it 24 hours after chemotherapy we allow the chemotherapy to exert its effect with cells actively in cell cycle, but delivering the Erlotinib at a time when cells are trying to return to cell cycle hence slowing the growth rate of the tumor cell population. By withdrawing the Erlotinib about 4 days prior to the next chemotherapy cycle, we allow the cells to go back into cell cycle and therefore become susceptible to chemotherapy again. Patients will be treated with intravenous paclitaxel over 3 hours followed by intravenous cisplatin/carboplatin on Day 1 of each 21 day cycle. Patients will be treated with Erlotinib at a loading dose of 300mg on Day 2 followed by 150 mg orally daily from Days 3-17 of each cycle of paclitaxel and cisplatin/carboplatin. The primary objectives of this study are to assess the response rate of combination of erlotinib, cisplatin/carboplatin and paclitaxel in the first line treatment setting of metastatic, recurrent and persistent squamous cell carcinoma of the head and neck. Secondary objectives are to assess toxicity, median survival, and progression free survival.
Interventions
DRUGErlotinib
loading dose of 300 mg on Day 2 followed by 150 mg daily Days 3 - 17 of each cycle of paclitaxel and cisplatin/carboplatin
Sponsors
Genentech, Inc.
Henry Ford Health System
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
* Squamous cell carcinoma of the head and neck region that is metastatic, recurrent or persistent after surgery and/or radiation * No prior chemotherapy for metastatic, recurrent or persistent disease
Exclusion criteria
* Not more than 1 prior adjuvant or neoadjuvant chemotherapy regimen is allowed * Chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response Rate of Intermittent Tarceva During First Line Standard Platinum Containing Chemotherapy | Evaluated at 6-week intervals, up to an average of 18 weeks. | Response rate of intermittent Tarceva will be measured by applying RECIST 1.0 criteria to measure response using radiologic testing. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Erlotinib Erlotinib (Tarceva) During First Line Standard Platinum Containing Chemo
Erlotinib: loading dose of 300 mg on Day 2 followed by 150 mg daily Days 3 - 17 of each cycle of paclitaxel and cisplatin/carboplatin | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Erlotinib |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 4 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Tumor Response Rate of Intermittent Tarceva During First Line Standard Platinum Containing Chemotherapy
Response rate of intermittent Tarceva will be measured by applying RECIST 1.0 criteria to measure response using radiologic testing.
Time frame: Evaluated at 6-week intervals, up to an average of 18 weeks.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Erlotinib | Tumor Response Rate of Intermittent Tarceva During First Line Standard Platinum Containing Chemotherapy | Disease Progression | 1 Participants |
| Erlotinib | Tumor Response Rate of Intermittent Tarceva During First Line Standard Platinum Containing Chemotherapy | Partial Response | 3 Participants |
| Erlotinib | Tumor Response Rate of Intermittent Tarceva During First Line Standard Platinum Containing Chemotherapy | Stable Disease | 2 Participants |