Ixabepilone in Treating Patients With Metastatic or Recurrent Squamous Cell Cancer of the Head and Neck
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
4 other identifiers
interventional
144
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2002
CompletedStudy Start
First participant enrolled
November 1, 2002
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedFebruary 27, 2013
February 1, 2013
4.2 years
April 9, 2002
February 26, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Response rate, assessed using RECIST criteria
95% confidence interval will be computed.
Up to 5 years
Secondary Outcomes (2)
Time to progression
From the date of entry on the study to the appearance of new metastatic lesions or objective tumor progression, assessed up to 5 years
Grade 3 of 4 hematologic toxicity
Up to 5 years
Study Arms (2)
Arm I (ixabepilone)
EXPERIMENTALPatients 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 (ixabepilone)
EXPERIMENTALPatients 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.
Interventions
Given IV
Eligibility Criteria
You may qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eastern Cooperative Oncology Group
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara Burtness
Eastern Cooperative Oncology Group
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2002
First Posted
January 27, 2003
Study Start
November 1, 2002
Primary Completion
January 1, 2007
Last Updated
February 27, 2013
Record last verified: 2013-02