late phase ii study of weekly paclitaxel (bms-181339) in patients with advanced or recurrent head and neck cancer

Conditions: Head and Neck Cancer

Summary: the purpose of this study is to evaluate the efficacy and the safety of paclitaxel given weekly in patients with advanced or recurrent head and neck cancer


Eligibility criteria:
inclusion criteria: * give written and voluntary informed consent. * patients with cytologically or histopathologically confirmed head and neck cancer (except for thyroid cancer) * patients with locally advanced head and neck cancer pretreated with surgery and/or radiotherapy (plus or minus one chemotherapy regimen) and not suitable for further radical local treatment or patients with distant metastases who may have received no or one chemotherapy regimen * patients must have measurable disease (lesion(s) with largest diameter of 10 mm or more) * patients with 4 weeks or longer interval from completion of previous therapy. (2 weeks for anti-metabolites, biological response modifiers (brm), bisphosphonates and brain only or bone irradiation /among radiotherapy/). all reversible residual effects of previous therapy should have resolved or stabilized to the best degree, as can be reasonably expected. * performance status of 0 - 2 * patients with normal major organ functions (hematologic, hepatic and renal, etc.) and who met listed below requirements at the time of evaluation done within 2 weeks prior to the scheduled first drug administration date * neutrophil count: ≤ 2,000/ul * platelet count: ≤ 100,000/ul * hemoglobin: ≤ 9.0g/dl * ast: \< 100 iu/l * alt:\< 100 iu/l * total bilirubin: ≤ 1.5 mg/dl * serum creatinine: ≤ 1.5 mg/dl * patients with expected survival period of at least 2 months or more from study initiation. * men and women, with age range of 20 years and older to less than 75 years. exclusion criteria: * women of childbearing potential (wocbp) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study * women who are pregnant or breastfeeding * women with a positive pregnancy test on enrollment or prior to study drug administration * sexually active fertile men not using an effective method of birth control for the entire study period and for up to 8 weeks after the study * patients with cns metastasis that are associated with clinical symptoms, and/or are associated with surrounding edema on ct scan or mri, or that require concomitant therapy with steroids or anti-convulsants * patients with active second cancer (synchronous second cancer or the disease-free interval from the previous second primary cancer to the current cancer is less than 5 years) * patients with serious, uncontrolled medical illness (i.e., serious cerebrovascular disorders, uncontrolled hypertension or diabetes mellitus, severe infections or active gastric ulcer, etc.), or acute inflammatory disease, etc. * patients with interstitial pneumonia or pulmonary fibrosis by chest ct-scan or clinical symptoms (e.g., fever, cough, shortness of breath or dyspnea) * patients with body cavity fluid retention which requires treatment (or an intervention). however, those who show no re-accumulation of pleural effusion for 2 weeks or longer without use of chemotherapy drugs (brm included) after post thoracentesis or a chest tube drainage are eligible for enrollment. in addition, those with water suction of pericardial effusion shall be ineligible for enrollment * patients who meet one of the following criteria; * either myocardial infarction or anginal attack within 6 months prior to this study participation * medical history of congestive heart failure * arrhythmia requiring treatment * conduction abnormality (left bundle-branch block, class ii and above atrioventricular \[av\] block) * patients with more than grade 1 peripheral neuropathy as graded by the nci-ctc version 2.0 criteria * patients with a history of hypersensitivity due to administration of drugs containing polyoxyethylene castor oil (cremophor el) (e.g., cyclosporine), or hardened castor oil (e.g., vitamin preparations for injection, etc.) * patients with previous therapy with taxanes (e.g., paclitaxel, docetaxel) * patients received investigational agents within 4 weeks prior to this study participation * patients who are compulsorily detained for legal reasons or treatment of either a psychiatric or physical (e.g., infectious disease) illness * patients who don't accept use of supportive therapies, i.e., blood transfusion for anemia