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| ID | Type | Description | Link |
|---|---|---|---|
| XRP6976G-322 |
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The purpose of the study is to compare time to progression and overall survival after treatment with Taxotere plus cisplatin versus cisplatin plus 5-FU (PF treatment group) in the first line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| docetaxel plus cisplatin | Experimental | Taxotere 75 mg/m², one-hour IV infusion on Day 1 of each 3-week cycle followed by cisplatin 75 mg/m² administered as a 30-minute to 3-hour infusion on Day 1 |
|
| cisplatin plus 5-FU | Active Comparator | Cisplatin 100 mg/m², 30-minute to 3-hour infusion on Day 1 of each 3-week cycle followed by the continuous infusion of 5-FU 1000 mg/m²/day from Day 1 to Day 5 |
|
| docetaxel plus 5-FU | Experimental | Taxotere 85 mg/m², one-hour IV infusion on Day 1 of each 3-week cycle followed by the continuous infusion of 5-FU 750 mg/m²/day from Day 1 to Day 5 Arm only in the phase II part of the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel (XRP6976) | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| time to progression | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival, overall response rate (complete response + partial response), duration of response, and time to treatment failure | up to 5 years |
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Inclusion Criteria:
Patients with histologically or cytologically documented squamous cell carcinoma of the head and neck (SCCHN) (eligible primary sites: oral cavity, oropharynx, hypopharyx, or larynx) presenting with locally recurrent and/or metastatic disease, with at least 1 unidimensionally or bidimensionally measurable lesion.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| sanofi-aventis US | Bridgewater | New Jersey | 08807 | United States | ||
| Sanofi-Aventis |
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| cisplatin |
| Drug |
|
| 5-fluorouracil (5-FU) | Drug |
|
| Buenos Aires |
| Argentina |
| sanofi-aventis, Australia | Macquarie Park | New South Wales | Australia |
| Sanofi-Aventis | Vienna | Austria |
| sanofi-aventis, Belgium | Diegem | Belgium |
| Sanofi-Aventis | Rio de Janeiro | Brazil |
| sanofi-aventis Canada | Laval | Quebec | Canada |
| sanofi-aventis, France | Paris | France |
| sanofi-aventis Germany | Berlin | Germany |
| sanofi-aventis Greece | Athens | Greece |
| Sanofi-Aventis | Basse-Terre | Guadeloupe |
| Sanofi-Aventis Hungaria | Budapest | Hungary |
| sanofi-aventis Israel | Netanya | Israel |
| sanofi-aventis Italy | Milan | Italy |
| Sanofi-Aventis | Saint-Denis | Reunion |
| Sanofi-Aventis | Moscow | Russia |
| sanofi-aventis South Africa | Midrand | South Africa |
| Sanofi-Aventis | Madrid | Spain |
| sanofi-aventis Switzerland | Geneva | Switzerland |
| Sanofi-Aventis | Montevideo | Uruguay |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009364 | Neoplasm Recurrence, Local |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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