Back to resultsA Phase II Trial Neoadjuvant Paclitaxel and Cisplatin in Patients With Locally Advanced Head and Neck Cancer
Primary Purpose
Head and Neck Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Paclitaxel
cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer
Eligibility Criteria
Inclusion Criteria: Locally advanced, Stage II-IV (except M1), hand and neck cancer > = 1 measurable lesion not been previously treated for head and neck cancer Exclusion Criteria: history of another malignancy organ allografts pre-exiting neuropathy > = CTC grade 2
Sites / Locations
- Local Insitution
- Local Institution
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
paclitaxel-cisplatin combination regimen
Arm Description
Outcomes
Primary Outcome Measures
Tumor response rate of locally advanced head and neck cancer to a paclitaxel-cisplatin combination regimen in a neoadjuvant setting and administered during maximum 3 cycles.
Secondary Outcome Measures
Toxicity for maximum 3 cycles
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00337532
Brief Title
A Phase II Trial Neoadjuvant Paclitaxel and Cisplatin in Patients With Locally Advanced Head and Neck Cancer
Official Title
A Phase II Trial Neoadjuvant Paclitaxel and Cisplatin in Patients With Locally Advanced Head and Neck Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
5. Study Description
Brief Summary
The purpose of this clinical research study is to learn if a paclitaxel-cisplatin combination regimen given in the neoadjuvant setting is active in locally advanced head and neck cancer. the safety of this treatment will also be studied.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Arm Title
paclitaxel-cisplatin combination regimen
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Sterile solution mixed with 0.9% saline or 5% glucose solution 500mL, 3-hour Continuous infusion, Level 0: 175 mg/m2, Level 1: 140 mg/m2, Level 2: 105 mg/m2 (dose reduction in function of toxicity), Day 1 of each cycle, max of 3 cycles; each cycle of 21 days ± 3 days.
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
solution mixed with 0.9% saline 500mL, 30 to 90 min intravenous infusion, Level 0: 75 mg/m2, Level 1: 60 mg/m2, Level 2: 45 mg/m2 (dose reduction in function of toxicity), Day 1 of each cycle, max of 3 cycles; each cycle of 21 days ± 3 days.
Primary Outcome Measure Information:
Title
Tumor response rate of locally advanced head and neck cancer to a paclitaxel-cisplatin combination regimen in a neoadjuvant setting and administered during maximum 3 cycles.
Secondary Outcome Measure Information:
Title
Toxicity for maximum 3 cycles
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Eligibility Criteria
Inclusion Criteria:
Locally advanced, Stage II-IV (except M1), hand and neck cancer
> = 1 measurable lesion
not been previously treated for head and neck cancer
Exclusion Criteria:
history of another malignancy
organ allografts
pre-exiting neuropathy > = CTC grade 2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Insitution
City
Seoul
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Phase II Trial Neoadjuvant Paclitaxel and Cisplatin in Patients With Locally Advanced Head and Neck Cancer
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