A Phase II Trial Neoadjuvant Paclitaxel and Cisplatin in Patients With Locally Advanced Head and Neck Cancer
Phase 2/Phase 3
18 Years
75 Years
18 Years
75 Years
Not Enrolling
Both
Head and Neck Cancer
Both
Head and Neck Cancer
Trial Information
A Phase II Trial Neoadjuvant Paclitaxel and Cisplatin in Patients With Locally Advanced Head and Neck Cancer
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
South Korea: Korea Food and Drug Administration (KFDA)
Study ID:
CA139-384
NCT ID:
NCT00337532
Start Date:
May 2005
Completion Date:
June 2007
Related Keywords:
- Head and Neck Cancer
- Head and Neck Neoplasms
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