Head and Neck Cancer Clinical Trial
Official title:
Late Phase II Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced or Recurrent Head and Neck Cancer
Verified date | October 2009 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Pharmaceuticals and Medical Devices Agency |
Study type | Interventional |
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
Status | Completed |
Enrollment | 36 |
Est. completion date | October 2006 |
Est. primary completion date | October 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 74 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response rate according to the WHO criteria | Every 4 weeks | No | |
Secondary | Duration of response according to the WHO criteria | Every 4 weeks | No | |
Secondary | Response rate according to RECIST criteria | Every 4 weeks | No |
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