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Head and Neck CancerPhase 2NCT00855764

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

A Phase 2 study testing Paclitaxel in people with Head and Neck Cancer, run by Bristol-Myers Squibb.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 20 to 74 years
Conditions the study is for
Head and Neck Cancer
What is being tested?
Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
No sites listed yet
Study dates
Oct 2005to Oct 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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)
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  • 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

About this study

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

Being tested
Paclitaxel
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

    Also called Taxol, BMS-181339

    Solution, IV, 100 mg/m2, weekly for 6 of 7 weeks, until evidence of disease progression or unacceptable side effects became apparent

Study groups in NCT00855764
Study groupRoleWhat they receive
PaclitaxelExperimentalNot described
Receives: Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate according to the WHO criteria

    Measured: Every 4 weeks

Secondary outcomes (2)

  1. Duration of response according to the WHO criteria

    Measured: Every 4 weeks

  2. Response rate according to RECIST criteria

    Measured: Every 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2009 (estimated)
  2. Study startOct 2005
  3. Primary completionOct 2006
  4. Study completionOct 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00855764
Sponsor's protocol ID
CA139-388
Status last verified
Oct 2009
First submitted
3 Mar 2009
Last updated
4 Feb 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel in people with Head and Neck Cancer, run by Bristol-Myers Squibb.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate according to the WHO criteria (time frame: Every 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00855764.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2010.

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