Clinical Trial Details

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Study ID 2009-0395
Investigator
William N. William Jr., MD,   UT MD Anderson Cancer Center
Title Docetaxel And Cisplatin With or Without Erlotinib For Metastatic Or Recurrent Squamous Cell Carcinoma Of Head And Neck
Conditions Head and Neck Cancer
Squamous Cell Carcinoma of the Head and Neck
Interventions Drug: Cisplatin
Drug: Docetaxel
Drug: Erlotinib
Other: Placebo
Drug: Carboplatin
Phase Phase 2
Purpose The goal of this clinical research study is to learn if adding Tarcevaâ (Erlotinib, OSI-774) to the combination of docetaxel and cisplatin/carboplatin can help control SCCHN better than chemotherapy alone, in patients with SCCHN that has spread to other parts of the body or has come back after treatment. The safety of this drug combination will also be studied.
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Both
Accepts Healthy Volunteers:  No
Inclusion Criteria: 1. Histologically confirmed metastatic or recurrent SCCHN of the oral cavity, oropharynx, hypopharynx or larynx. Metastatic or recurrent lesions of the nasopharynx and sinus are excluded. 2. Radiologically 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. Measurable lymph nodes are required to be >/= 15 mm in size (short axis diameter). 3. Age >/= 18 years 4. ECOG PS /= 1.5 x 109/L; Platelet count >/= 100 x 109/L; Total bilirubin /= grade 2. 7. History of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (eg, Crohn's disease, ulcerative colitis). Patients requiring feeding tubes are permitted. 8. Other active malignancies requiring chemotherapy treatment within 2 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical or breast cancer or superficial, resected melanoma. 9. Serious underlying medical condition which would impair the ability of the patient to receive protocol treatment, in the opinion of the treating physician. 10. History of allergic reactions to compounds of similar chemical composition to the study drugs (docetaxel, cisplatin, carboplatin, erlotinib or their excipients), or other drugs formulated with polysorbate 80. 11. Any concurrent anti-cancer therapy, excluding hormonal therapy for prostate or breast cancer. 12. Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent. 13. Women who are pregnant or breast-feeding and women or men not practicing effective birth control.
Study Location
UT MD Anderson Cancer Center
Houston, Texas, 77030
Contact William N. William Jr., MD
713-792-6363
Information objtained from ClinicalTrials.gov, on 4/18/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064479


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