CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 123 enrolled
Drug / intervention
Carboplatin +7 moredrug
Likely dose
Not stated in 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/NCT01064479
NCT01064479Phase 2Completed

A Randomized, Placebo-Controlled, Phase 2 Study of Docetaxel and Cisplatin/Carboplatin With or Without Erlotinib in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck

M.D. Anderson Cancer Center·interventional·Posted Feb 8, 2010·Updated Jul 16, 2024

In Brief

A Phase 2 clinical trial evaluating Carboplatin, Cisplatin, and 6 other interventions for Metastatic Squamous Cell Carcinoma of the Hypopharynx and 23 related conditions. Completed, enrolled 123 participants across 5 sites.

Detailed Summary

This randomized phase II trial studies how well combination chemotherapy with or without erlotinib hydrochloride works in treating patients with squamous cell carcinoma of the head and neck that has spread to other parts of the body or has come back. Drugs used in chemotherapy, such as docetaxel, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy with or without erlotinib hydrochloride may be an effective treatment for squamous cell carcinoma of the head and neck.

Study Details

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 8, 2010
Enrollment StartFeb 5, 2010
Primary CompletionNov 3, 2020
TodayJul 2, 2026
Enrollment to primary: 10.7 yearsPosted 16.4 years ago

Interventions

Carboplatindrug

Given IV

Cisplatindrug

Given IV

Docetaxeldrug

Given IV

Erlotinib Hydrochloridedrug

Given PO

Laboratory Biomarker Analysisother

Optional correlative studies

Pharmacological Studyother

Optional correlative studies

Placeboother

Given PO

Quality-of-Life Assessmentother

Ancillary studies