NCT00231465

Phase II Study of Docetaxel + ZD1839 in Elderly Patients With Non-Small Cell Lung Cancer

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	docetaxel (Taxotere®)	Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued.
DRUG	ZD1839	ZD1839 will be continued until progression, or until trial closure, whichever comes first.

Timeline

• Start date: 2003-07-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2005-10-04
• Last updated: 2017-03-03
• Results posted: 2012-11-30

Locations

1 site across 1 country: United States