Phase II Study of Docetaxel + ZD1839 in Elderly Patients With Non-Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT00231465|
Recruitment Status : Completed
First Posted : October 4, 2005
Results First Posted : November 30, 2012
Last Update Posted : March 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Drug: docetaxel (Taxotere®) Drug: ZD1839||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||July 2003|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
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.
- Overall Response Rate (ORR) [ Time Frame: Duration of time on study, an average of 19 months ]ORR: Complete Response (CR) + Partial Response (PR). Response rate for Elderly (> 70 years) previously untreated patients with Stage IIIb (With Malignant Pleural Effusion (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 longest diameter (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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|