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| Sponsors and Collaborators: |
Eastern Cooperative Oncology Group 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 |
| MedlinePlus related topics: | Cancer Head and Neck Cancer Salivary Gland Disorders |
| ChemIDplus related topics: | Ixabepilone Salicylsalicylic acid Sodium salicylate |
| 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 |
| Study Start Date: | November 2002 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) that is incurable with surgery or radiotherapy
Measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations![]() |
Show 84 Study Locations |
| Eastern Cooperative Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | Barbara A. Burtness, MD | Yale University |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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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]
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| 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 |
| First Received: | April 9, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00033618 |
| Health Authority: | United States: Federal Government |
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