Study of Chemotherapy With Cisplatin/Carboplatin, and Docetaxel With or Without Erlotinib in Patients With Head and Neck Squamous Cell Carcinomas Amenable for Surgical Resection

PHASE2CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

December 16, 2013

Primary Completion Date

January 6, 2025

Study Completion Date

January 6, 2025

Conditions
Head and Neck Cancer
Interventions
DRUG

Docetaxel

75 mg/m2 by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles.

DRUG

Erlotinib

150 mg by mouth daily continuously until the day before surgery.

OTHER

Placebo

150 mg by mouth daily continuously until the day before surgery.

BEHAVIORAL

Questionnaires

Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery.

BEHAVIORAL

Phone Call

Phone call made to patient 1 time each year after the end of treatment visit.

DRUG

Chemotherapy

Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Astellas Pharma Inc

INDUSTRY

collaborator

The Kadoorie Charitable Foundations

OTHER

lead

M.D. Anderson Cancer Center

OTHER

NCT01927744 - Study of Chemotherapy With Cisplatin/Carboplatin, and Docetaxel With or Without Erlotinib in Patients With Head and Neck Squamous Cell Carcinomas Amenable for Surgical Resection | Biotech Hunter | Biotech Hunter