Scottsdale, Arizona 85259

  • Recurrent Squamous Cell

Purpose:

Randomized phase II trial to study the effectiveness of ixabepilone in treating patients who have metastatic or recurrent head and neck cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die


Study summary:

PRIMARY OBJECTIVES: I. To determine the response rate and toxicity of BMS-247550 given in two dosing schedules in taxane-naïve and taxane-exposed patients. II. To provide information about the response rate and toxicity of BMS-247550 given in two dosing schedules. SECONDARY OBJECTIVES: I. To measure surviving expression and correlate with the therapeutic responsiveness to BMS-247550. II. To determine the changes in tumor vascular density and endothelial cell apoptosis in response to therapy and the correlation of these changes to outcome. 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.


Criteria:

Inclusion Criteria: - Patients must have measurable histologically confirmed squamous cell carcinoma of the head and neck, excluding nasopharyngeal primaries, that is incurable with surgery or radiation therapy; disease must be measurable as defined by RECIST =< 4 weeks of randomization - Patients must have distant metastases or locoregional recurrence or persistent disease within a radiation portal - Baseline tumor measurements/evaluations must be obtained < 4 weeks prior to randomization - Patients may have received up to one prior biotherapy regimen and treatment must have been completed at least 4 weeks prior to randomization; no more than two prior chemotherapy regimens for recurrent and/or metastatic disease are permitted; patients may have received prior docetaxel or paclitaxel, but must not have been previously treated with an investigational taxane; chemotherapy treatment must have been completed at least 4 weeks prior to randomization - If the only site of measurable disease is a previously irradiated area, the patient must have documented progressive disease or biopsy-proven residual carcinoma; persistent disease after radiotherapy must be biopsy-proven at least 8 weeks after the completion of radiotherapy; patients must have completed radiotherapy at least 4 weeks prior to randomization - Patients must not have a concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix; patients with prior malignancies who have been disease-free > 2 years are eligible - Patients must have ECOG performance status of 0 or 1 - Absolute neutrophil count (ANC) >= 1500/mm^3 - Platelet count >= 100,000/mm^3 - Serum creatinine =< 1.2 mg OR creatinine clearance >= 50 ml/min NOTE: Either calculated or actual creatinine clearance can be used NOTE: The creatinine clearance may be calculated by the Cockcroft-Gault formula - Total bilirubin =< 1.5 mg - (SGOT) AST, (SGPT) ALT =< 2 x institutional upper limit of normal - Alkaline phosphatase =< 2 x institutional upper limit of normal - Serum calcium within institutional normal range and no history of malignancy associated hypercalcemia - Patients must not have a pre-existing peripheral neuropathy >= grade 2 - Patients must not have an active infection nor currently be receiving treatment for a recent infection - Patients must have recovered from the effects of any recent surgery - Female patients must not be pregnant or breastfeeding; the effects of BMS-247550 on pregnant women and on fetuses are unknown; however, the known toxicities, which include neutropenia, are likely to place pregnant women at increased risk; the mechanism of action of this compound, stabilization of microtubules in dividing cells, is highly likely to be teratogenic; taxanes, which have a similar mechanism of action, are known to be teratogenic NOTE: A negative serum pregnancy test is required =< 2 weeks of randomization for women of childbearing potential - Women of childbearing potential and sexually active males must agree to use an accepted and effective method of contraception - Patients must not have a known hypersensitivity to castor oil, or agents containing Cremophor El, or paclitaxel; patients with a history of grade 1 or uncomplicated, non-recurrent grade 2 hypersensitivity reactions associated with Cremophor will be eligible with prophylaxis


Study is Available At:


Original ID:

NCI-2012-02970


NCT ID:

NCT00033618


Secondary ID:

E2301


Study Acronym:


Brief Title:

Ixabepilone in Treating Patients With Metastatic or Recurrent Squamous Cell Cancer of the Head and Neck


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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

144


Enrollment Type:

Actual


Overall Contact Information

Official Name:Barbara Burtness
Principal Investigator
Eastern Cooperative Oncology Group

Study Dates

Start Date:November 2002
Primary Completion Date:January 2007
Primary Completion Type:Actual
Verification Date:February 2013
Last Changed Date:February 26, 2013
First Received Date:April 9, 2002

Study Outcomes

Outcome Type:Primary Outcome
Measure:Response rate, assessed using RECIST criteria
Time Frame:Up to 5 years
Safety Issues:False
Description:95% confidence interval will be computed.
Outcome Type:Secondary Outcome
Measure:Time to progression
Time Frame:From the date of entry on the study to the appearance of new metastatic lesions or objective tumor p
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Grade 3 of 4 hematologic toxicity
Time Frame:Up to 5 years
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:ixabepilone
Description:Given IV
Arm Name:Arm I (ixabepilone)
Other Name:BMS-247550
Intervention Type:Other
Name:laboratory biomarker analysis
Description:Correlative studies
Arm Name:Arm I (ixabepilone)

Study Arms

Study Arm Type:Experimental
Arm Name:Arm I (ixabepilone)
Description: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.
Study Arm Type:Experimental
Arm Name:Arm II (ixabepilone)
Description: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.

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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]
PMID:18296423
Reference Type:Results Reference
Citation: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.
Reference Type:Results Reference
Citation: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.

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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