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Completed Phase 1Phase 2 Interventional Results available

Pemetrexed Plus Cetuximab in Patients With Recurrent Non Small Cell Lung Cancer

ClinicalTrials.gov ID: NCT00216203

Public ClinicalTrials.gov record NCT00216203. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 24, 2026, 6:55 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase I-IIa Dose-Ranging Study of Pemetrexed (Alimta) Plus Cetuximab (Erbitux) in Patients With Recurrent Non-Small Cell Lung Cancer (NSCLC): Hoosier Oncology Group LUN04-79

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Both pemetrexed and cetuximab have single agent activity in NSCLC and non-overlapping toxicity profiles. While 2-drug combination therapy has proven superior to single agent therapy in the first-line setting of NSCLC, no such phase III trials have been reported in the second-line setting. Therefore, the purpose of this study is to determine the feasibility of combining these drugs, assessing the toxicity profile, determining the MTD and evaluating the activity of the combination in an expanded phase II setting. If the combination appears to have promising activity, further evaluation of this regimen may be warranted comparing it to single agent pemetrexed or cetuximab alone.

Study identification

NCT ID
NCT00216203
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Nasser Hanna, M.D.
Other
Enrollment
36 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 30, 2005
Primary completion
Nov 30, 2008
Completion
Nov 30, 2008
Last update posted
Sep 28, 2016

2005 – 2008

United States locations

U.S. sites
11
U.S. states
5
U.S. cities
11
Facility City State ZIP Site status
Medical & Surgical Specialists, LLC Galesburg Illinois 61401 —
Cancer Care Center of Southern Indiana Bloomington Indiana 47403 —
Elkhart Clinic Elkhart Indiana 46515 —
Fort Wayne Oncology & Hematology, Inc Fort Wayne Indiana 46815 —
Center for Cancer Care at Goshen Health System Goshen Indiana 46527 —
Indiana University Cancer Center Indianapolis Indiana 46202 —
Medical Consultants, P.C. Muncie Indiana 47303 —
Northern Indiana Cancer Research Consortium South Bend Indiana 46601 —
Greenebaum Cancer Center Baltimore Maryland 21201 —
Oncology Hematology Care, Inc. Cincinnati Ohio 45242 —
Texas Oncology Cancer Center Austin Texas 78731 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00216203, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 28, 2016 · Synced Sep 24, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00216203 live on ClinicalTrials.gov.

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