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Also known as Tarceva, Erlotinib Hydrochloride
OSI-774 · 1 trial · 1 indication
Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v.1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient growth to qualify for PD; Progressive Disease (PD), \>= 20% increase in the sum of the longest diameter from the smallest sum diameter recorded, NE = not evaluable
| Arm | Type | Description |
|---|---|---|
| Cisplatin + Docetaxel + OSI-774 | EXPERIMENTAL | Cisplatin 75 mg/m\^2 IV every 21 days. Docetaxel 60 mg/m\^2 IV repeated every 21 days. OSI-774 100 mg oral administered daily. May have a dose escalation of 150 mg pending on prior dose toleration. Patients will continue on daily OSI-774 until a study endpoint or removal from study is reached. |
| Name | Type | Description |
|---|---|---|
| Docetaxel | DRUG | 60 mg/m\^2 IV repeated every 21 days. |
| OSI-774 | DRUG | 100 mg oral administered daily. May have a dose escalation of 150 mg pending on prior dose toleration. Patients will continue on daily OSI-774 until a study endpoint or removal from study is reached. |
| Cisplatin | DRUG | 75 mg/m\^2 IV every 21 days. |
Inclusion Criteria: 1. Have histologically or cytologically confirmed metastatic or recurrent head and neck squamous cell carcinoma from the primary lesion and/or lymph nodes of the oral cavity, oropharynx, hypopharynx, or larynx. 2. Have measurable disease, defined as at least one lesion that can ...
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OSI-774 is an investigational small molecule being studied for head and neck cancer, specifically head and neck squamous cell cancer. It has been evaluated in a Phase 2 trial in combination with cisplatin and Taxotere. It is not an approved therapy and remains in clinical development.
OSI-774 is being developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche holds the development program for this small molecule oncology candidate.
OSI-774 is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The program has enrolled 50 patients in total across its clinical work to date.
OSI-774 has been studied in the completed Phase 2 trial NCT00076310, titled OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer. That trial enrolled 50 patients in the United States and was an uncontrolled study without randomization or double blinding.
OSI-774 is not approved and remains an investigational agent in clinical development. Its only recorded trial, a Phase 2 study in head and neck squamous cell cancer, has completed, and no active trials are ongoing for the program.