Study of TARCEVA (Erlotinib) as Adjuvant Treatment for Locally Advanced Head and Neck Squamous Cell Carcinoma

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT01515137
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Erlotinib — DRUG
    Erlotinib (150 mg PO QD) plus sulindac (150 mg PO BID) (Arm A), Erlotinib (150 mg PO QD) (Arm B) or placebo (for Erlotinib) QD (Arm C).
  • Erlotinib plus sulindac — DRUG
    Erlotinib (150 mg PO QD) plus sulindac (150 mg PO BID) (Arm A), Erlotinib (150 mg PO QD) (Arm B) or placebo (for Erlotinib) QD (Arm C).
  • Placebo — DRUG
    Erlotinib (150 mg PO QD) plus sulindac (150 mg PO BID) (Arm A), Erlotinib (150 mg PO QD) (Arm B) or placebo (for Erlotinib) QD (Arm C).

Study Details

This trial was originally designed and powered to compare biomarker modulation in the neo-adjuvant setting (erlotinib versus erlotinib plus sulindac versus placebo) with clinical response to erlotinib in the adjuvant setting. Since implementing the trial in late 2005, The investigators have encountered significant obstacles to implementing the adjuvant therapy phase of the trial. * Barriers included: 1. disease recurrence 2. patient refusal to take the agent 3. patient refusal to travel to Pittsburgh for clinical evaluations. Given the institutional challenges to implement and complete the adjuvant portion, the investigators have decided to change the primary endpoint to a biomarker modulation endpoint. To achieve this goal, the investigators determined that they needed 39 paired tissue specimens (see statistical justification below). The central hypothesis to be tested in this study is that persistent activation of parallel and/or downstream pathways contributes to tumor progression in the setting of EGFR blockade. While not all head and neck squamous cell carcinoma (HNSCC) patients will respond to EGFR targeting, the optimal strategy to identify those subjects whose tumors are sensitive to EGFR inhibition remains unknown. The primary objective is centered around the concept of tumor biomarkers which may be modulated by EGFR and Cox-2 inhibitors and may serve as future therapeutic targets for therapy. To this end patients on this trial will be randomly assigned to one of three arms to receive either Tarceva, Tarceva plus sulindac, or a placebo in the 2 week pre-operative period. A panel of biomarkers will be obtained by biopsy prior to pre-operative therapy and again at surgery. Biomarkers will be examined for modulation in the 2-week pre-operative period, for group differences, for treatment effects and for further understanding of protein signaling pathways. Sample size for the primary objective Modification of Statistical Design: The primary endpoint is the difference between pre (biopsy) and post (surgery). There are 3 hypotheses of interest: (1) placebo vs erlotinib alone, (2) placebo versus erlotinib plus sulindac, and (3) erlotinib vs erlotinib + sulindac. With a randomization in a 3:5:5 ratio, we have 88% power, alpha = .01 for an omnibus test to show between-group differences of 1 log exist. This requires 39 patients. Basically, 39 patients will provide the ability to detect a one log difference between any 2 of the 3 groups in pre-post change.

Key Dates

First listed
Jan 23, 2012
Start date
Nov 30, 2005
Status verified
Jan 2016
Primary completion
Sep 30, 2014
Completion
Sep 30, 2014

Study Design

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

Arms

  • Experimental: Arm A erlotinib plus sulindac
    erlotinib (150 mg PO QD) plus sulindac (150 mg PO BID) (Arm A),
  • Experimental: Arm B erlotinib
    erlotinib (150 mg PO QD) (Arm B)
  • Experimental: Arm C
    placebo (for Erlotinib) QD (Arm C).

Primary Outcome Measure

Phase II Study of TARCEVA (Erlotinib) as Adjuvant Treatment for Locally Advanced Head and Neck Squamous Cell Carcinoma with Evaluation of Neoadjuvant Biomarker Modulation with TARCEVA vs. TARCEVA Plus Sulindac [ Time Frame: 10 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pittsburgh Cancer InstitutePittsburghPennsylvania15232-

Find similar trials in Pittsburgh, PA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
University of Pittsburgh Cancer Institute· Pittsburgh, PA

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