OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer (NCT00076310) | Clinical Trial Compass
Active — Not RecruitingPhase 2
OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer
United States50 participantsStarted 2004-01-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
âś“. 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.
âś“. 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.
âś“. 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.
âś“. Be \>= 18 years of age.
âś“. No acute intercurrent illness or infection.
âś“. ECOG performance status =\<2 (Karnofsky =\>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) =\<2.5 X institutional upper limit of normal if alkaline phosphate is \<ULN OR alkaline phosphatase may be up to 4x ULN if transaminases are \<ULN; creatinine =\<2.0 xULN OR creatinine clearance \>60 mL/min/1.73 m\*\*2 for patients with creatinine levels above institutional normal
âś“. The effects of OSI-774 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 3 months after the completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
What they're measuring
1
Overall Response Assessment (Radiographic RECIST)
Timeframe: after 2 cycles of treatment (6 weeks) and confirmed 4-6 weeks thereafter
. History of non-melanoma skin cancer, or other malignancies treated 5 years or more prior to the current tumor, from which the patient has remained continually disease-free, are eligible.
Exclusion criteria
âś•. Patients who have had chemotherapy or non-palliative radiotherapy for their recurrent or metastatic head and neck cancer.
âś•. Patients may not be receiving any other investigational agents.
âś•. Brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
âś•. History of allergic reactions attributed to compounds of similar chemical or biologic composition to OSI-774 or other agents used in the study.
âś•. Patient has received prior biologic therapy targeting EGFR.
âś•. Signs or symptoms of acute infection requiring systemic therapy.
âś•. Exhibits confusion, disorientation, or has a history of major psychiatric illness that may impair patient's understanding of the informed consent.
âś•. Requires total parenteral nutrition with lipids.