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NCT01515137 · ClinicalTrials.gov registry record · Phase 1
Study of TARCEVA (Erlotinib) as Adjuvant Treatment for Locally Advanced Head and Neck Squamous Cell Carcinoma
A Phase 1 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
NCT01515137 is a Phase 1 study that has completed, run by University of Pittsburgh. The registered enrollment target is 47 participants.
The verdict
NCT01515137, a Phase 1 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
Study Summary
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 endpoi
Interventions
- DRUG Placebo
- DRUG Erlotinib
- DRUG Erlotinib plus sulindac
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2005-11 |
| Est. Completion | 2014-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01515137
The ClinicalTrials.gov registry entry for NCT01515137 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01515137 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01515137 about?
NCT01515137 is a clinical study titled "Study of TARCEVA (Erlotinib) as Adjuvant Treatment for Locally Advanced Head and Neck Squamous Cell Carcinoma". 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 encounte...
What is the current status of trial NCT01515137?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2005-11. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01515137?
The interventions under investigation include: Placebo (DRUG), Erlotinib (DRUG), Erlotinib plus sulindac (DRUG).
Who is sponsoring clinical trial NCT01515137?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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