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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Head and Neck Cancer

Treatments: Drug: Paclitaxel; Drug: cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00337532

CA139-384

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

paclitaxel-cisplatin combination regimen

Active Comparator group

Treatment:

Drug: Paclitaxel

Drug: cisplatin