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Completed
NCT00076310
OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer
Conditions: Head and Neck Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 50
Sponsor: M.D. Anderson Cancer Center
Location: MD Anderson Cancer Center Houston Texas
Summary
The goal of this clinical research study is to learn if giving the new drug, Tarceva® (OSI-774), in combination with Platinol® (cisplatin) and Taxotere® (docetaxel) is effective in the treatment of metastatic or recurrent head and neck cancer. The safety of this treatment will also be studied.
Eligibility Criteria
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 be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral CT scan. See section 9.2 for the evaluation of measurable disease.
3. Have not received any prior systemic chemotherapy for metastatic or recurrent head and neck squamous cell carcinoma. If patients have received prior combined modality therapy, they must be off therapy for at least 6 months.
4. Be \>= 18 years of age.
5. No acute intercurrent illness or infection.
6. ECOG performance status =\60%). Have normal organ and marrow function defined as: leukocytes=\>3,000/uL; absolute neutrophil count=\>1,500/uL; platelets =\>100,000/uL hemoglobin \>= 8g/dl; total bilirubin within normal institutional limits; AST(SGOT)/ALT(SGPT) =\
Source: ClinicalTrials.gov (NCT00076310). StuddyBuddy aggregates publicly available trial information.