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

Primary Purpose

Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, Recurrent Metastatic Squamous Neck Cancer With Occult Primary, Recurrent Salivary Gland Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ixabepilone
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eastern Cooperative Oncology Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I (ixabepilone)

Arm II (ixabepilone)

Arm 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.

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.

Outcomes

Primary Outcome Measures

Response rate, assessed using RECIST criteria
95% confidence interval will be computed.

Secondary Outcome Measures

Time to progression
Grade 3 of 4 hematologic toxicity

Full Information

First Posted
April 9, 2002
Last Updated
February 26, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00033618
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, Recurrent Metastatic Squamous Neck Cancer With Occult Primary, Recurrent Salivary Gland Cancer, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx, Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Recurrent Verrucous Carcinoma of the Larynx, Recurrent Verrucous Carcinoma of the Oral Cavity, Salivary Gland Squamous Cell Carcinoma, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IVA Salivary Gland Cancer, Stage IVA Squamous Cell Carcinoma of the Larynx, Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVA Verrucous Carcinoma of the Larynx, Stage IVA Verrucous Carcinoma of the Oral Cavity, Stage IVB Salivary Gland Cancer, Stage IVB Squamous Cell Carcinoma of the Larynx, Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVB Squamous Cell Carcinoma of the Oropharynx, Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVB Verrucous Carcinoma of the Larynx, Stage IVB Verrucous Carcinoma of the Oral Cavity, Stage IVC Salivary Gland Cancer, Stage IVC Squamous Cell Carcinoma of the Larynx, Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVC Squamous Cell Carcinoma of the Oropharynx, Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVC Verrucous Carcinoma of the Larynx, Stage IVC Verrucous Carcinoma of the Oral Cavity, Tongue Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (ixabepilone)
Arm Type
Experimental
Arm 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.
Arm Title
Arm II (ixabepilone)
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
ixabepilone
Other Intervention Name(s)
BMS-247550, epothilone B lactam, Ixempra
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Response rate, assessed using RECIST criteria
Description
95% confidence interval will be computed.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Time to progression
Time Frame
From the date of entry on the study to the appearance of new metastatic lesions or objective tumor progression, assessed up to 5 years
Title
Grade 3 of 4 hematologic toxicity
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Burtness
Organizational Affiliation
Eastern Cooperative Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastern Cooperative Oncology Group
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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