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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued.
ZD1839 will be continued until progression, or until trial closure, whichever comes first.
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Overall Response Rate (ORR)
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.
Time frame: Duration of time on study, an average of 19 months
Progression Free Survival (PFS) Rate
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.
Time frame: Duration of time on study, an average of 19 months
Overall Survival (OS) Rate
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.
Time frame: Duration of time on study, an average of 19 months
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