Clinical trial NCT00855764: Late Phase II Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced or Recurrent Head and Neck Cancer
Official title: Late Phase II Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced or Recurrent Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-03-04
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Response rate according to the WHO criteria
timeFrame: Every 4 weeks
Secondary outcomes:
measure: Duration of response according to the WHO criteria
timeFrame: Every 4 weeks
measure: Response rate according to RECIST criteria
timeFrame: Every 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: