A Phase 2/3 interventional study of docetaxel (XRP6976) and cisplatin in Head and Neck Neoplasms, Neoplasm Recurrence, Local and Neoplasm Metastasis, sponsored by Sanofi. Completed at 20 sites in 20 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-01-20.
Sponsored by Sanofi · Phase 2/3, Interventional, and Treatment
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.
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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.
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
Drug: docetaxel (XRP6976) · Drug: cisplatin
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
Drug: cisplatin · Drug: 5-fluorouracil (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
Drug: docetaxel (XRP6976) · Drug: 5-fluorouracil (5-FU)
Also known as: Taxotere
time to progression
Time frame: up to 5 years
overall survival, overall response rate (complete response + partial response), duration of response, and time to treatment failure
Time frame: up to 5 years
This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.
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