A Randomized Phase II-III Multicenter Trial of Docetaxel Plus Cisplatin and Docetaxel Plus 5-FU Versus Cisplatin Plus 5-FU in 1st Line Treatment of Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck.
Overview
- Phase
- Phase 2
- Intervention
- 5-fluorouracil (5-FU)
- Conditions
- Head and Neck Neoplasms
- Sponsor
- Sanofi
- Enrollment
- 568
- Locations
- 13
- Primary Endpoint
- time to progression
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
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.
Investigators
Eligibility 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.
Exclusion Criteria
- Not provided
Arms & Interventions
docetaxel plus 5-FU
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
Intervention: 5-fluorouracil (5-FU)
docetaxel plus cisplatin
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
Intervention: docetaxel (XRP6976)
docetaxel plus cisplatin
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
Intervention: cisplatin
cisplatin plus 5-FU
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
Intervention: cisplatin
cisplatin plus 5-FU
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
Intervention: 5-fluorouracil (5-FU)
docetaxel plus 5-FU
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
Intervention: docetaxel (XRP6976)
Outcomes
Primary Outcomes
time to progression
Time Frame: up to 5 years
Secondary Outcomes
- overall survival, overall response rate (complete response + partial response), duration of response, and time to treatment failure(up to 5 years)