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

Phase 2
20 Years
74 Years
Not Enrolling
Head and Neck Cancer

Thank you

Trial Information

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

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

- 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

- 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

- 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

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate according to the WHO criteria

Outcome Time Frame:

Every 4 weeks

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


Japan: Pharmaceuticals and Medical Devices Agency

Study ID:




Start Date:

October 2005

Completion Date:

October 2006

Related Keywords:

  • Head and Neck Cancer
  • Head and Neck Neoplasms