CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 50 enrolled
Drug / intervention
Docetaxel +2 moredrug
Likely dose
Docetaxel 60 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/NCT00076310
NCT00076310Phase 2Active
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A Phase II Study of OSI-774 in Combination With Cisplatin and Docetaxel in Metastatic or Recurrent Head and Neck Squamous Cell Cancer

M.D. Anderson Cancer Center·interventional·Posted Jan 21, 2004·Updated Apr 15, 2026

In Brief

A Phase 2 clinical trial evaluating Docetaxel, OSI-774, and 1 other intervention for Head and Neck Cancer. Active but no longer recruiting, targeting 50 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if giving the new drug, Tarceva® (OSI-774), in combination with Platinol® (cisplatin) and Taxotere® (docetaxel) is effective in the treatment of metastatic or recurrent head and neck cancer. The safety of this treatment will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 2ActiveOverdue
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 21, 2004
Enrollment StartJan 28, 2004
Primary CompletionMay 1, 2025
Study CompletionJun 30, 2026
TodayJul 2, 2026
Enrollment to primary: 21.3 yearsPosted 22.4 years ago

Interventions

Docetaxeldrug

60 mg/m\^2 IV repeated every 21 days.

OSI-774drug

100 mg oral administered daily. May have a dose escalation of 150 mg pending on prior dose toleration. Patients will continue on daily OSI-774 until a study endpoint or removal from study is reached.

Cisplatindrug

75 mg/m\^2 IV every 21 days.