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A Phase II Trial Neoadjuvant Paclitaxel and Cisplatin in Patients With Locally Advanced Head and Neck Cancer

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00337532
First received: June 14, 2006
Last updated: February 2, 2010
Last verified: June 2008
History of Changes

June 14, 2006
February 2, 2010
May 2005
June 2007   (final data collection date for primary 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.
Same as current
Complete list of historical versions of study NCT00337532 on ClinicalTrials.gov Archive Site
Toxicity for maximum 3 cycles
Same as current
Not Provided
Not Provided
 
A Phase II Trial Neoadjuvant Paclitaxel and Cisplatin in Patients With Locally Advanced Head and Neck Cancer
A Phase II Trial Neoadjuvant Paclitaxel and Cisplatin in Patients With Locally Advanced Head and Neck Cancer

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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Cancer
  • Drug: Paclitaxel
    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.
  • Drug: cisplatin
    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.
Active Comparator: paclitaxel-cisplatin combination regimen
Interventions:
  • Drug: Paclitaxel
  • Drug: cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2007
June 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00337532
CA139-384
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP