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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| Amgen | INDUSTRY |
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This study is being done to test whether panitumumab, in combination with chemotherapy and radiation is safe in people with head and neck cancer. Another goal of this study is to find the highest dose of the study drugs that can be given safely without causing serious sife effects. Panitumumab is a type of drug called a monoclonal antibody that has been studied in other types of cancers, such as kidney and colon. This monoclonal antibody is directed against the epidermal growth factor receptor (EGFR). EGFR has been found on the majority of head and neck cancer cells. By blocking EGFR, this monoclonal antibody may inhibit the growth of head and neck cancer cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | Determine the best dosing of panitumumab, chemotherapy and radiation. |
|
| Part B | Experimental | Determine the best dosing of induction chemotherapy combined with panitumumab prior to receiving panitumumab and chemoradiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panitumumab | Drug | Part A: Intravenously once a week for 7 weeks Part B (Induction Chemotherapy): Intravenously on Day 1 of a 21-day cycle for 3 cycles Part B (After Induction chemotherapy): Intravenously once a week for 7 weeks at the dosing level established during Part A |
| Measure | Description | Time Frame |
|---|---|---|
| To identify the maximally tolerated dose of paclitaxel given with panitumumab plus carboplatin chemoradiotherapy. | 2 years | |
| To identify the maximally tolerated dose or biologically acceptable dose of TPF, varying the 5-FU dose, given with a fixed dose of panitumumab, prior to concurrent carboplatin, paclitaxel, panitumumab chemoradiotherapy. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of the combination of Pan-CRT and Pan-TPF. | 2 years | |
| To estimate the overall response rate to Pan-TPF. | 2 years | |
| To estimate the overall response rate of sequential therapy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lori J. Wirth, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Wirth, L.J. Phase I Study of Panitumumab, Chemotherapy, and Intensity-modulated Radiotherapy (IMRT) for head and neck cancer (HNC). Abstract-No.6083 2007 ASCO Annual Meeting |
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| Carboplatin | Drug | Part A: Intravenously once weekly for 7 weeks Part B (Following induction therapy): Intravenously once a week for 7 weeks |
|
| Paclitaxel | Drug | Part A: Intravenously once weekly for 7 weeks Part B (Following induction therapy): Intravenously once a week for 7 weeks |
|
| Intensity Modulated Radiation Therapy | Radiation | Part A: Daily five days a week for 7 weeks Part B (After Induction therapy): Daily five days a week for 7 weeks |
|
|
| 5-Fluorouracil | Drug | Intravenously at one of two dose levels on days 1-4 of a 21-day cycle for three cycles |
|
|
| Docetaxel | Drug | Intravenously on day 1 of a 21-day cycle for 3 cycles |
|
| Cisplatin | Drug | Intravenously on day 1 of a 21-day cycle for 3 cycles |
|
| 2 years |
| To estimate the rate of pathologic complete response of primary tumor biopsy, to estimate 2-year disease free survival and overall survival. |
| To evaluate functional outcome at 2 years with respect to speech, swallowing and overall quality of life. | 2 years |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D002277 | Carcinoma |
| D018196 | Carcinoma, Adenosquamous |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D018193 | Neoplasms, Complex and Mixed |
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| ID | Term |
|---|---|
| D000077544 | Panitumumab |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| D050397 | Radiotherapy, Intensity-Modulated |
| D005472 | Fluorouracil |
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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