CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Docetaxel +3 moredrug
Likely dose
Docetaxel 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01437449
NCT01437449Phase 2Completed
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Weekly Docetaxel, Cisplatin, and Cetuximab (TPC) in Palliative Treatment of Patients With SCCHN

Stanford University·interventional·Posted Sep 20, 2011·Updated Jan 30, 2024

In Brief

A Phase 2 clinical trial evaluating Docetaxel, Cisplatin, and 2 other interventions for Head and Neck Cancer. Completed, enrolled 27 participants across 2 sites.

Detailed Summary

Docetaxel and cetuximab are FDA-approved for the treatment of squamous cell carcinoma of the head and neck (SCCHN). Cisplatin and carboplatin, while not FDA-approved for SCCHN, have been used as standard of care in SCCHN patients in combination with other drugs. This study evaluates if weekly cisplatin and docetaxel, in combination with cetuximab, is effective in palliative treatment of patients with SCCHN. These drugs will be given intravenously weekly, repeated 3 of every 4 weeks until evidence of disease progression or unacceptable adverse events.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 20, 2011
Enrollment StartOct 1, 2011
Primary CompletionSep 11, 2018
Study CompletionAug 1, 2019
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 14.8 years ago

Interventions

Docetaxeldrug

30 mg/m² by intravenous (IV) administration

Cisplatindrug

30 mg/m² by intravenous (IV) administration

Cetuximabdrug

400 mg/m² by intravenous (IV) administration, thereafter 250 IV

Carboplatindrug

Area under the free carboplatin plasma concentration versus time curve (AUC)=2 by intravenous (IV) administration