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

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

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