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Induction Chemotherapy Using Paclitaxel, Carboplatin, CPT-11 With Pegfilgrastim

NCT00280787 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2013-02-05

No results posted yet for this study

Summary

Patients enrolled on this study will have been diagnosed with non-small cell lung cancer which cannot be removed by an operation. The standard treatment for this disease is a combination of chemotherapy and radiation therapy; however, the best way to combine these treatments is not known. This study will examine if the combination of chemotherapy and radiotherapy has an increased effect on slowing tumor growth with the addition of a drug called ZD1839.

In this study, chemotherapy will be given initially (induction therapy) to try to control the spread of the cancer. Then radiation and chemotherapy will be given together. Receiving chemotherapy at the same time as radiation treatments can enhance the effect of the radiation. In this study, patients will receive a drug called ZD1839. In laboratory tests on cancer cells, ZD1839 has shown an additive effect when used in combination with radiation. ZD1839 has also been shown to slow or stop growth in tumors.

The purpose of this study is to determine the side effects and effectiveness of using ZD1839 when used with radiation in this treatment regimen (induction chemotherapy followed by combination chemotherapy, ZD1839, and radiation therapy).

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

Paclitaxel

175 mg/m2 administered on Day 1, of a 21 day cycle. Subjects will receive 2 cycles

DRUG

Carboplatin

Area Under the Curve(AUC)=5 administered on Day 1 of a 21 day cycle. Subjects will receive 2 cycles.

DRUG

CPT-11

100 mg/m2 administered on Day 1 of each 21 day cycle. Subjects will receive 2 cycles.

DRUG

Pegfilgrastim

6 mg administered on Day 2 each each 21 day cylce. Subjects will receive 2 cycles of treatment.

RADIATION

Conformal radiotherapy

Radiation therapy will be administered with standard daily fractionation of 2.0 Gy per fraction, 5 days per week.The total dose of radiotherapy will be 74 Gy

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Amgen

    collaborator INDUSTRY

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • David Morris, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-30
Primary Completion
2006-01-31
Completion
2010-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT00280787 on ClinicalTrials.gov