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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01927744
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Docetaxel — DRUG
    75 mg/m2 by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles.
  • Erlotinib — DRUG
    150 mg by mouth daily continuously until the day before surgery.
  • Placebo — OTHER
    150 mg by mouth daily continuously until the day before surgery.
  • Questionnaires — BEHAVIORAL
    Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery.
  • Phone Call — BEHAVIORAL
    Phone call made to patient 1 time each year after the end of treatment visit.
  • Chemotherapy — DRUG
    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.

Study Details

The goal of this clinical research study is to learn if adding erlotinib to a standard chemotherapy combination (docetaxel and either cisplatin or carboplatin) can help to control SCCHN. The safety of this drug combination will also be studied. In this study, erlotinib will be compared to a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect. This is an investigational study. Erlotinib is approved by the FDA for treatment of non-small cell lung cancer. Its use in this study is experimental. Docetaxel, cisplatin, and carboplatin are all FDA approved and commercially available for the treatment of SCCHN. Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.

Key Dates

First listed
Aug 23, 2013
Start date
Dec 16, 2013
Status verified
Oct 2025
Primary completion
Jan 6, 2025
Completion
Jan 6, 2025

Study Design

Enrollment
55 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Chemotherapy + Erlotinib
    Docetaxel 75 mg/m2 by vein followed by 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, plus Erlotinib 150 mg by mouth daily continuously until the day before surgery. Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery. Phone call made to patient 1 time each year after the end of treatment visit.
  • Experimental: Chemotherapy + Placebo
    Docetaxel 75 mg/m2 by vein followed by 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, plus placebo 150 mg by mouth daily continuously until the day before surgery. Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery. Phone call made to patient 1 time each year after the end of treatment visit.

Primary Outcome Measure

Major Pathologic Response (MPR) Rate (Primary (Overall) Analysis) [ Time Frame: At surgery following completion of induction chemotherapy (up to approximately 63 days after treatment initiation). ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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