Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Pleural Effusion, Malignant

Pleural Effusion

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Docetaxel

Gefitinib

Tubulin Modulators

Antimitotic Agents

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

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.

Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued.

docetaxel (Taxotere®)

ZD1839 will be continued until progression, or until trial closure, whichever comes first.

ZD1839

Alberto Chiappori, MD

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.

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)

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.

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.

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.

AstraZeneca

H. Lee Moffitt Cancer Center and Research Institute

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.

ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.

docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued.

Taxotere® (Docetaxel) + ZD1839 (IRESSA®)

Age, Customized

Sex: Female, Male

United States

Region of Enrollment

Alberto Chiappori, M.D.

Response was evaluable in 42 of the 44 patients.

Overall Response Rate (ORR)

All participants who initiated therapy between March 2003 and May 2005

Progression Free Survival (PFS) Rate

Overall Survival (OS) Rate

Eligible patients were treated with docetaxel 75 mg/m2 every three weeks and gefitinib 250 mg orally daily. Docetaxel and ZD1839 (gefitinib) were given for two cycles beyond maximal response. Gefitinib was continued until disease progression. Co-morbidities and activities of daily living were assessed (IADL).

Spots Global Cancer Trial Database for Phase II Study of Docetaxel + ZD1839 in Elderly Patients With Non-Small Cell Lung Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial