MedTrace Logo

CPT-11/Cisplatin and Celecoxib With Radiation Therapy for Patients With Unresectable Non-Small Cell Lung Cancer (NSCLC)

NCT00346801 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-10-22

No results posted yet for this study

Summary

Primary Objectives:

* To determine the feasibility, activity, and toxicity of a novel regimen using a concurrent irinotecan (CPT-11)/cisplatin and celecoxib combination for patients with unresectable NSCLC.
* To determine the maximal tolerance dose of celecoxib in patients with unresectable NSCLC treated with irinotecan/cisplatin and concurrent thoracic radiation therapy.
* To correlate the COX-2 expression and other biomarkers with response to the treatment in the tumor from a pretreatment biopsy specimen.

Conditions

Interventions

DRUG

Celecoxib

100 mg by mouth (PO) twice daily for 5 days before beginning radiation therapy; continued 7 days per week throughout radiation treatment (about 7 weeks).

DRUG

Cisplatin

25 mg/m\^2 IV over 60 minutes on Day 1, Weeks 2-8

DRUG

CPT-11

30 mg/m\^2 IV over 90 minutes on Day 1, Weeks 2-8, followed by cisplatin which will be infused for 60 minutes.

RADIATION

Concurrent Thoracic Radiation Therapy

63 Gy at 1.8 Gy/Fx in 35 Fractions over 7 weeks starting 2nd week of celebrex.

Sponsors & Collaborators

Principal Investigators

  • Ritsuko R Komaki, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2012-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00346801 on ClinicalTrials.gov