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Ixabepilone in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
This study has been completed.
First Received: April 9, 2002   Last Updated: July 23, 2008   History of Changes
Sponsor: Eastern Cooperative Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00033618
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Randomized phase II trial to study the effectiveness of ixabepilone in treating patients who have metastatic or recurrent head and neck cancer.


Condition Intervention Phase
Head and Neck Cancer
Drug: ixabepilone
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Randomized Phase II Study Of BMS-247550 (NSC 710428) Given Daily X 5 Days Every 3 Weeks Or Weekly In Patients With Metastatic Or Recurrent Squamous Cell Cancer Of The Head And Neck

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 2002
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Compare the response rate in patients with metastatic or recurrent squamous cell carcinoma of the head and neck treated with 2 different dosing schedules of ixabepilone.
  • Compare the toxicity of these drug schedules in these patients.
  • Correlate survivin expression with therapeutic responsiveness to this drug in these patients.
  • Correlate changes in tumor vascular density and endothelial cell apoptosis with outcome in patients treated with this drug.

OUTLINE: This is a randomized study. Patients are stratified according to prior taxane therapy (yes vs no) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive ixabepilone IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

In both arms, patients achieving complete response (CR) receive 2 additional courses past CR if a minimum of 6 courses have been administered.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 64-144 patients (16-36 per stratum) will be accrued for this study within 8-18 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) that is incurable with surgery or radiotherapy

    • No nasopharyngeal primaries
  • Measurable disease

    • If the only site of measurable disease is in a previously irradiated area, then patient must have documented disease progression or biopsy-proven residual carcinoma
    • Persistent disease after radiotherapy must be biopsy proven at least 8 weeks after completion of radiotherapy
  • Must have distant metastases or locoregional recurrence or persistent disease within a prior radiation portal

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • AST and ALT no greater than 2 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2 times ULN

Renal:

  • Creatinine no greater than 1.2 mg/dL OR
  • Creatinine clearance at least 50 mL/min
  • Calcium normal
  • No prior malignancy-associated hypercalcemia

Other:

  • No other prior or concurrent malignancy within the past 2 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No grade 2 or greater pre-existing peripheral neuropathy
  • No active infection
  • No greater than grade 1 or uncomplicated, non-recurrent grade 2 hypersensitivity reaction to castor oil, agents containing Cremophor EL, or paclitaxel
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior biologic therapy
  • No more than 1 prior biologic therapy regimen

Chemotherapy:

  • At least 4 weeks since prior chemotherapy
  • No more than 2 prior chemotherapy regimens for recurrent and/or metastatic SCCHN
  • No prior investigational taxane
  • Prior docetaxel or paclitaxel allowed

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy

Surgery:

  • Recovered from prior surgery

Other:

  • No concurrent treatment for a recent infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00033618

  Show 84 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Barbara A. Burtness, MD Yale University
  More Information

Additional Information:
Publications:
Burtness BA, Manola J, Axelrod R, Argiris A, Forastiere AA. A randomized phase II study of ixabepilone (BMS-247550) given daily x 5 days every 3 weeks or weekly in patients with metastatic or recurrent squamous cell cancer of the head and neck: an Eastern Cooperative Oncology Group study. Ann Oncol. 2008 Feb 21; [Epub ahead of print]
Burtness B, Goldwasser MA, Axelrod R, et al.: A randomized phase II study of BMS-247550 (ixabepilone) given daily x 5 days every 3 weeks or weekly in patients with metastatic or recurrent squamous cell cancer of the head and neck. [Abstract] J Clin Oncol 24 (Suppl 18): A-5532, 288s, 2006.
Burtness B, Manola J, Argiris A, et al.: Randomized phase II study of BMS-247550 (NSC 710428) given daily X 5 days or weekly in patients with metastatic or recurrent squamous cell cancer of the head and neck: E2301. [Abstract] European Journal of Cancer Supplements 4 (12): A-632, 190, 2006.

Study ID Numbers: CDR0000069305, ECOG-E2301
Study First Received: April 9, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00033618     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
untreated metastatic squamous neck cancer with occult primary
recurrent metastatic squamous neck cancer with occult primary
metastatic squamous neck cancer with occult primary squamous cell carcinoma
stage IV squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent salivary gland cancer
salivary gland squamous cell carcinoma
stage IV salivary gland cancer

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Epothilones
Head and Neck Neoplasms
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009