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

NCT ID: NCT00337532

Last Updated: 2010-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2007-06-30

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

paclitaxel-cisplatin combination regimen

Group Type: ACTIVE_COMPARATOR

Paclitaxel

Intervention Type: DRUG

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.

cisplatin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Insitution

Seoul, , South Korea

Local Institution

Seoul, , South Korea

Countries

South Korea

Other Identifiers

CA139-384

Identifier Type: -

Identifier Source: org_study_id