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

Phase 2

Completed

• Conditions: Head and Neck Cancer
• Interventions: Drug: Paclitaxel; Drug: cisplatin

• Registration Number: NCT00337532
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2006-06-14
• Study First Submitted QC: 2006-06-15
• Study First Posted: 2006-06-16
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2008-06
• Disposition First Submitted: 2010-02-02
• Disposition First Submitted QC: 2010-02-02
• Last Update Submitted: 2010-02-02
• Disposition First Posted: 2010-02-04
• Last Update Posted: 2010-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
paclitaxel-cisplatin combination regimen	Paclitaxel	-
paclitaxel-cisplatin combination regimen	cisplatin	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Toxicity for maximum 3 cycles

Trial Locations

Locations (2)

Local Institution; 🇰🇷 Seoul, Korea, Republic of

Local Insitution; 🇰🇷 Seoul, Korea, Republic of