Phase II Study of Docetaxel + ZD1839 in Elderly Patients With Non-Small Cell Lung Cancer
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.
Non-Small Cell Lung Cancer
Drug: docetaxel (Taxotere®)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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)|
- Overall Response Rate (ORR) [ Time Frame: Duration of time on study, an average of 19 months ] [ Designated as safety issue: No ]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.
- Progression Free Survival (PFS) Rate [ Time Frame: Duration of time on study, an average of 19 months ] [ Designated as safety issue: No ]PFS was calculated from the date of enrollment to the date of progression. All 44 treated were assessed for PFS, with a minimum follow-up of 19 months. Progression (PD): At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
- Overall Survival (OS) Rate [ Time Frame: Duration of time on study, an average of 19 months ] [ Designated as safety issue: No ]OS was calculated from the date of enrollment to the date of death. All 44 treated were assessed for OS, with a minimum follow-up of 19 months.
|Study Start Date:||July 2003|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Experimental: Taxotere® (Docetaxel) + ZD1839 (IRESSA®)
Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.
ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.
Drug: docetaxel (Taxotere®)
Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued.
Other Name: Taxotere®Drug: ZD1839
ZD1839 will be continued until progression, or until trial closure, whichever comes first.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00231465
|United States, Florida|
|H. Lee Moffitt Cancer Center & Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Alberto Chiappori, MD||H. Lee Moffitt Cancer Center and Research Institute|