Bevacizumab/Tarceva and Tarceva/Sulindac in Squamous Cell Carcinoma of the Head and Neck

Conditions

• Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — DRUG
  Given intravenously on day one of each 3 week cycle
• erlotinib — DRUG
  Given orally once a day
• Sulindac — DRUG
  Given orally twice a day

Study Details

The main purpose of this research study is to collect information to learn how effective erlotinib (tarceva) is in combination with either bevacizumab or sulindac in treating patients with squamous cell carcinoma of the head and neck. Erlotinib and bevacizumab are targeted therapy drugs that can control tumor growth by targeting specific abnormalities sometimes found on cancer cells. Erlotinib targets epidermal growth factor receptor (EGFR), and bevacizumab targets vascular endothelial growth factor (VEGF). Sulindac is a non-steroidal anti-inflammatory drug (NSAID) that can block G protein-coupled receptor which laboratory evidence shows is associated with both cancer cell growth and EGFR activity. The bevacizumab being administered in this study is not a commercially marketed formulation of the drug. Previous research with head and neck cancer suggest that erlotinib alone has some anti-cancer activity. This research study is designed to see how well erlotinib works in combination with bevacizumab or sulindac in head and neck cancer.

Key Dates

First listed

Oct 26, 2006

Start date

Oct 31, 2006

Status verified

Mar 2017

Primary completion

Aug 31, 2012

Completion

Dec 31, 2013

Study Design

Enrollment

36 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Erlotinib + Bevacizumab
  erlotinib plus bevacizumab
• Active Comparator: Erlotinib + Sulindac
  erlotinib plus sulindac

Primary Outcome Measure

Efficacy of Erlotinib Plus Bevacizumab (Arm A) or Erlotinib Plus Sulindac (Arm B) as Measured by Progression-free Survival. [ Time Frame: 1 year ]

Locations (2)

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