Conditions: Non-Small Cell Lung Cancer
Keywords: elderly malignant pleural effusion
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 44
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: 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.

Interventions: intervention 1: docetaxel (Taxotere®) intervention 2: ZD1839
Intervention descriptions: intervention 1: Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued. intervention 2: ZD1839 will be continued until progression, or until trial closure, whichever comes first.

Protocol document: