Trials / Completed

CompletedNCT01064479

Combination Chemotherapy With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck

A Randomized, Placebo-Controlled, Phase 2 Study of Docetaxel and Cisplatin/Carboplatin With or Without Erlotinib in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 123 (actual)

Sponsor: M.D. Anderson Cancer Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies how well combination chemotherapy with or without erlotinib hydrochloride works in treating patients with squamous cell carcinoma of the head and neck that has spread to other parts of the body or has come back. Drugs used in chemotherapy, such as docetaxel, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy with or without erlotinib hydrochloride may be an effective treatment for squamous cell carcinoma of the head and neck.

Detailed description

PRIMARY OBJECTIVES: I. Assess the efficacy of adding erlotinib hydrochloride (erlotinib) to chemotherapy to improve progression free survival in patients with metastatic or recurrent squamous cell carcinoma of the head and neck. SECONDARY OBJECTIVES: I. Evaluate overall survival, response rate, disease control rate, and duration of response by treatment with or without erlotinib. II. Evaluate quality of life (patient reported outcomes) by treatment with or without erlotinib. III. Evaluate the safety profile of erlotinib in combination with chemotherapy. IV. Correlate the occurrence of erlotinib-induced rash with outcomes. V. To evaluate the steady-state pharmacokinetics of erlotinib. VI. To explore the prognostic and predictive value of epidermal growth factor receptor related biomarkers and other biomarkers, including blood and tissue proteomic and blood and tissue genomic markers, that may be associated with clinical outcomes. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive docetaxel intravenously (IV) over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1, and erlotinib hydrochloride orally (PO) daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment. ARM B: Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment. After completion of study treatment, patients are followed up at 30 days.

Conditions

Interventions

Type	Name	Description
DRUG	Carboplatin	Given IV
DRUG	Cisplatin	Given IV
DRUG	Docetaxel	Given IV
DRUG	Erlotinib Hydrochloride	Given PO
OTHER	Laboratory Biomarker Analysis	Optional correlative studies
OTHER	Pharmacological Study	Optional correlative studies
OTHER	Placebo	Given PO
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

Start date: 2010-02-05
Primary completion: 2020-11-03
Completion: 2020-11-03
First posted: 2010-02-08
Last updated: 2024-07-16
Results posted: 2022-01-25

Locations

5 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT01064479. Inclusion in this directory is not an endorsement.