CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
docetaxel (Taxotere®) +1 moredrug
Likely dose
Docetaxel for maximum 2 cycles; ZD1839 (dose not specified in interventions) continued until progressionAI-extracted
Key inclusion· 7
  • ✓Age ≥70 years
  • ✓Histologically confirmed NSCLC, Stage IIIb with pleural effusion or Stage IV
  • ✓Previously untreated for metastatic disease (prior adjuvant chemotherapy allowed if >6 months before registration)
  • ✓At least unidimensionally measurable disease; measurable disease outside prior radiation ports if lesions within irradiated field
Key exclusion· 9
  • ✕Prior chemotherapy or ZD1839 treatment
  • ✕Active CNS metastases (stable, previously treated brain metastases allowed)
  • ✕Concurrent serious infections (e.g., receiving intravenous antibiotic)
  • ✕Unstable or serious concurrent medical condition: uncontrolled ventricular arrhythmia, recent myocardial infarction, uncontrolled seizure disorder, grade 3 neuropathies, spinal cord compression, superior vena cava syndrome, or psychiatric disorder preventing informed consent

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00231465
NCT00231465Phase 2Completed
CompareCT.gov

Phase II Study of Taxotere® (Docetaxel) + ZD1839 (IRESSA®) in Previously Untreated Elderly Patients (≥70 Years Old) With Stage III-b (With Malignant Pleural Effusion [MPE+]) or Stage IV Non-Small Cell Lung Cancer (NSCLC)

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Oct 4, 2005·Updated Mar 3, 2017

In Brief

A Phase 2 clinical trial evaluating docetaxel (Taxotere®) and ZD1839 for Non-Small Cell Lung Cancer. Completed, enrolled 44 participants across 1 site.

Detailed Summary

This is a Phase II, open-label trial of Taxotere® + ZD1839 in elderly patients with Stage III-b or IV NSCLC who have received no prior chemotherapy for metastatic disease. Patients with prior adjuvant chemotherapy were allowed to enroll on this trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
CountriesUnited States
CollaboratorsAstraZeneca

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 4, 2005
Enrollment StartJul 1, 2003
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9.1 yearsPosted 20.7 years ago

Interventions

docetaxel (Taxotere®)drug

Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued.

ZD1839drug

ZD1839 will be continued until progression, or until trial closure, whichever comes first.