Taxotere (Docetaxel) in 1st Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Sanofi

Status and phase: Completed; Phase 3; Phase 2

Conditions: Neoplasm Metastasis; Head and Neck Neoplasms; Neoplasm Recurrence, Local

Treatments: Drug: cisplatin; Drug: 5-fluorouracil (5-FU); Drug: docetaxel (XRP6976)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00401323

EFC6051

XRP6976G-322

Details and patient eligibility

About

The purpose of the study is to compare time to progression and overall survival after treatment with Taxotere plus cisplatin versus cisplatin plus 5-FU (PF treatment group) in the first line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.

Enrollment: 568 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Patients with histologically or cytologically documented squamous cell carcinoma of the head and neck (SCCHN) (eligible primary sites: oral cavity, oropharynx, hypopharyx, or larynx) presenting with locally recurrent and/or metastatic disease, with at least 1 unidimensionally or bidimensionally measurable lesion.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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568 participants in 3 patient groups

docetaxel plus cisplatin

Experimental group

Description:

Taxotere 75 mg/m², one-hour IV infusion on Day 1 of each 3-week cycle followed by cisplatin 75 mg/m² administered as a 30-minute to 3-hour infusion on Day 1

Treatment:

Drug: docetaxel (XRP6976)

Drug: cisplatin

cisplatin plus 5-FU

Active Comparator group

Description:

Cisplatin 100 mg/m², 30-minute to 3-hour infusion on Day 1 of each 3-week cycle followed by the continuous infusion of 5-FU 1000 mg/m²/day from Day 1 to Day 5

Treatment:

Drug: 5-fluorouracil (5-FU)

Drug: cisplatin

docetaxel plus 5-FU

Experimental group

Description:

Taxotere 85 mg/m², one-hour IV infusion on Day 1 of each 3-week cycle followed by the continuous infusion of 5-FU 750 mg/m²/day from Day 1 to Day 5 Arm only in the phase II part of the study

Treatment:

Drug: 5-fluorouracil (5-FU)

Drug: docetaxel (XRP6976)