Late Phase II Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced or Recurrent Head and Neck Cancer

Study Overview
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Brief Summary
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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

Official Title
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Late Phase II Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced or Recurrent Head and Neck Cancer

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel<br> | Drug: Paclitaxel<br>* Solution, IV, 100 mg/m2, weekly for 6 of 7 weeks, until evidence of disease progression or unacceptable side effects became apparent<br>* Other names: BMS-181339;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate according to the WHO criteria |  | Every 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of response according to the WHO criteria |  | Every 4 weeks | 
| Response rate according to RECIST criteria |  | Every 4 weeks |