William N. William Jr., MD, UT MD Anderson Cancer Center
Docetaxel And Cisplatin With or Without Erlotinib For Metastatic Or Recurrent Squamous Cell Carcinoma Of Head And Neck
Head and Neck Cancer
Squamous Cell Carcinoma of the Head and Neck
The goal of this clinical research study is to learn if adding Tarceva (Erlotinib, OSI-774)
to the combination of docetaxel and cisplatin/carboplatin can help control squamous cell
carcinoma of the head and neck (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.
Ages Eligible: 18 Years
Accepts Healthy Volunteers:
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 = 2
5. Adequate bone marrow, hepatic and renal function defined by: ANC >/= 1.5 x 109/L;
Platelet count >/= 100 x 109/L; Total bilirubin = ULN (excluding Gilbert's
disease); ALT (SGPT) = 1.5 x ULN; Alkaline phosphatase = 2.5 x ULN; Serum
creatinine = 1.5 x ULN.
6. Patients with reproductive potential (eg, females menopausal for less than 1 year and
not surgically sterilized) must practice effective contraceptive measures for the
duration of study drug therapy and for at least 30 days after completion of study
drug therapy. Female patients of childbearing potential must provide a negative
pregnancy test (serum or urine) = 14 days prior to treatment initiation.
7. Written informed consent to participate in the study according to the investigational
review board (IRB) or independent ethics committee (IEC).
1. Histology other than squamous cell carcinoma.
2. Primary sites other than oral cavity, oropharynx, hypopharynx, and larynx.
3. Prior palliative chemotherapy for metastatic or recurrent disease.
4. Prior biological therapy for metastatic or recurrent disease within 3 weeks prior to
5. Patients with known, untreated brain metastases. Patients with treated (irradiated or
resected) brain metastases are eligible if treatment was completed more than 28 days
prior to study entry and if clinical neurologic function is stable.
6. Pre-existing peripheral neuropathy >/= 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
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
UT MD Anderson Cancer Center
Houston, Texas, 77030
William N. William Jr., MD
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Information objtained from ClinicalTrials.gov, on
9/17/2014. For additional information about
this and other clinical trials,
Please refer to this study by its ClinicalTrials.gov identifier: