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)
This trial is designed to test the efficacy and tolerability of a standard chemotherapy
agent, Docetaxel, in combination with an oral agent, Iressa, in elderly patients with
advanced stage lung cancer. Current practices utilize two chemotherapeutic medications that
may result in increased toxicities and poor outcomes in the elderly population. Treatment
consists of an infusion of docetaxel every 21 days for four doses while taking Iressa every
day. A computed tomography (CT) scan will measure disease response after two cycles.
Response determines continuation of treatment. Lab work will be collected before every
treatment. Side effect information will also be collected at every visit. Once the infusion
phase of the study is completed, a maintenance phase of taking just the Iressa begins and
disease assessment occurs every two months. This period will last until disease progression
is demonstrated.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate (ORR)
Response Rate: Complete Response (CR) + Partial Response (PR). To determine the response rate for Elderly (> 70 years) previously untreated patients with Stage IIIb (With MPE) or IV non-small cell lung cancer (NSCLC) receiving Taxotere + ZD1839. Best clinical response to treatment with combination was determined using Response Evaluation Criteria in Solid Tumors (RECIST V1.0): * Complete Response (CR)- Disappearance of all target lesions; * Partial Response (PR)- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; * Progressive Disease (PD)- At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; * Stable Disease (SD)- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Duration of time on study, an average of 19 months
No
Alberto Chiappori, MD
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
MCC-12905
NCT00231465
July 2003
August 2012
Name | Location |
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H. Lee Moffitt Cancer Center & Research Institute | Tampa, Florida 33612 |