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Completed

NCT Number: NCT00252798

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.

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Key information

Conditions

Non Small Cell Lung Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Woolloonabba, Queensland, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gefitinib

Drug

carboplatin

Drug

paclitaxel

Drug

Radiation

Procedure

Primary outcomes

  1. 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 outcomes

  1. To evaluate the activity potential of the combination of ZD1839, carboplatin, paclitaxel & radiation therapy

  2. Estimating the objective response rate (complete response [CR] & partial response [PR]) as assessed by positron emission tomography with (18F)-labelled fluorodeoxyglucose (PET-FDG)

  3. To estimate the objective response rate (CR and PR) as assessed by computerised tomography (CT) scan

  4. To estimate the complete response rate (CR) as assessed by PET-FDG

  5. To estimate progression free survival (PFS) as assessed by clinical examination, chest x-ray, CT scan ± PET-FDG

  6. To estimate overall survival

  7. To characterise the safety and tolerability of ZD1839 combined with concurrent carboplatin, paclitaxel and radiation

  8. To determine the site of first failure (characterised as local-regional, distant or both)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2005
First posted
Nov 15, 2005
Registry last updated
Dec 19, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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