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Low Accrual, Funding
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib | Experimental | Erlotinib (Tarceva) During First Line Standard Platinum Containing Chemo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | loading dose of 300 mg on Day 2 followed by 150 mg daily Days 3 - 17 of each cycle of paclitaxel and cisplatin/carboplatin |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Evaluated at 6-week intervals, up to an average of 18 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haythem Ali, M.D/ | Henry Ford Health System | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Evaluated at 6-week intervals, up to an average of 18 weeks. |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| lymphopenia | Blood and lymphatic system disorders | Systematic Assessment |
the study did not accrue fully and was closed due to poor accrual
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tiffany Pearce, Director of Clinical Trials | Henry Ford Health System | 313-575-8046 | tpearce1@hfhs.org |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 4 |
| 6 |
| anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| hearing loss | Ear and labyrinth disorders | Systematic Assessment |
|
| lymphopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Neutropenic fever | Blood and lymphatic system disorders | Systematic Assessment |
|
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| D009370 |
| Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |