ZD1839 (Iressa™) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung Cancer

December 16, 2007 updated by: AstraZeneca

A Phase I Trial to Evaluate ZD1839(Iressa™) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung Cancer

The primary objective of the trial is to determine the Maximum tolerated dose, if any, of the combination of daily ZD1839 250 mg with carboplatin AUC 2 and 60 Gray (Gy) irradiation and up to 45 mg/m2 paclitaxel.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

44

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Woolloonabba, Queensland, Australia
        • Research Site
    • Victoria
      • East Melbourne, Victoria, Australia
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with histologically or cytologically confirmed locally advanced stage IIIA or IIIB NSCLC (without pleural effusion)
  • Patients with apical tumours and supraclavicular nodes are acceptable if both can be easily encompassed in one radiation field
  • Minimum life expectancy with treatment of 6 months
  • WHO performance status 0-1

Exclusion Criteria:

  • Patients with previous malignancies other than NSCLC
  • Previous radiotherapy for NSCLC
  • Previous immunotherapy or chemotherapy
  • Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
  • Forced expiratory volume in 1 second (FEV1) less than 1 litre (L)
  • Absolute neutrophil count (ANC) less than 1.5 x 109/L or platelets less than 100 x 109/L
  • Serum bilirubin greater than 1.25 times the upper limit of reference range
  • ALT or AST greater than 2.5 times the ULRR

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine the Maximum tolerated dose, if any, of the combination of daily ZD1839 250 mg with carboplatin AUC 2 and 60 Gray (Gy) irradiation and up to 45 mg/m2 paclitaxel.

Secondary Outcome Measures

Outcome Measure
To evaluate the activity potential of the combination of ZD1839, carboplatin, paclitaxel & radiation therapy
Estimating the objective response rate (complete response [CR] & partial response [PR]) as assessed by positron emission tomography with (18F)-labelled fluorodeoxyglucose (PET-FDG)
To estimate the objective response rate (CR and PR) as assessed by computerised tomography (CT) scan
To estimate the complete response rate (CR) as assessed by PET-FDG
To estimate progression free survival (PFS) as assessed by clinical examination, chest x-ray, CT scan ± PET-FDG
To estimate overall survival
To characterise the safety and tolerability of ZD1839 combined with concurrent carboplatin, paclitaxel and radiation
To determine the site of first failure (characterised as local-regional, distant or both)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

November 1, 2005

First Submitted That Met QC Criteria

November 10, 2005

First Posted (Estimate)

November 15, 2005

Study Record Updates

Last Update Posted (Estimate)

December 19, 2007

Last Update Submitted That Met QC Criteria

December 16, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D7913C00073
  • 1839IL/0073

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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