Phase II Study of Docetaxel + ZD1839 in Elderly Patients With Non-Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: docetaxel (Taxotere®); ZD1839
Intervention description: 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.
Intervention MeSH terms: Docetaxel; Gefitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No
Keywords: elderly; malignant pleural effusion

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be greater than or equal to 70 years of age.

          -  Patients must have histologically confirmed non-small cell lung cancer (NSCLC) that is
             Stage IIIb (with pleural effusions) or Stage IV.

          -  Patients must be previously untreated for metastatic disease but may have received
             previous adjuvant chemotherapy more than six months prior to registration. Patients
             may also have received radiation therapy for advanced disease; however there should be
             measurable disease outside the radiation ports.

          -  Disease must be at least unidimensionally measurable. Lesions, which are located
             within a previously irradiated field, are not considered measurable unless there is a
             documented growth in its size.

          -  Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of
             0 or 1.

          -  Laboratory values must be as follows: White blood cell count greater than or equal to
             3,000/mm^3; Absolute neutrophil count greater than or equal to 1,500/mm^3; Platelets
             greater than or equal to 100,000/mm^3; Total bilirubin less than or equal to 1.0 x
             institutional upper normal limit; Serum creatinine less than or equal to 2 x
             institutional upper normal limit; aspartic transaminase (AST) or ALANINE TRANSAMINASE
             (ALT) less than or equal to 1.5 x institutional upper normal limit; Alkaline
             Phosphatase less than or equal to 1.5 x institutional upper normal limit; Serum
             calcium less than or equal to 1.5 x institutional upper normal limit (corrected for
             serum albumin).

          -  Patients with combined alkaline phosphatase, AST and/or ALT elevations will not be
             allowed to enroll on protocol.

          -  Patients must have recovered from all acute toxicities from previous therapy,
             excluding alopecia.

          -  In keeping with the policies of the institution, patients must sign an informed
             consent form indicating that they are aware of the investigational nature of this
             study

          -  Patients with stable brain metastases after completion of radiation will be allowed to
             enroll in this trial.

          -  Patients treated with adjuvant therapy more than six months ago will be allowed to
             enroll in this trial.

          -  Cognitively impaired patients will be allowed to enroll on the trial if the legal
             guardian signs the consent form after a full informed consent process is completed.
             Whenever feasible the cognitively impaired person will also give assent to
             participation in the trial.

        Exclusion Criteria:

          -  Patients previously treated with chemotherapy or ZD1839.

          -  Patients with known or clinical evidence of active central nervous system (CNS)
             metastasis. Patients with stable, previously treated brain metastases will be allowed.

          -  Male Patients with female sexual partners in the reproductive age group who refuse to
             use effective methods of contraception will be excluded from the trial.

          -  Patients with concurrent serious infections (i.e., receiving an intravenous
             antibiotic) are not eligible.

          -  Patients with an unstable or serious concurrent medical condition are excluded.
             Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent
             (within 3 months) myocardial infarction, uncontrolled major seizure disorder, grade 3
             neuropathies, spinal cord compression, superior vena cava syndrome, or any psychiatric
             disorder that prohibits obtaining informed consent.

          -  Patients receiving other non-approved or investigational therapy concurrently or
             within 30 days of Day 1 of trial treatment.

          -  Patients with a history of other cancers except basal cell skin cancers, carcinoma of
             the cervix in situ, or curatively-treated cancers with > 2 years non-recurrence prior
             to entry in the trial. Patients with a history of other cancers must have histological
             confirmation that current disease is compatible with diagnosis of NSCLC.

          -  Peripheral neuropathy >2. (Peripheral neuropathy must be < grade 1)

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to Docetaxel, ZD 1839, Polysorbate 80, or other agents used in the study.

          -  Patients with combined alkaline phosphatase, AST and/or ALT elevations will be
             excluded from this protocol.

          -  Patients previously treated with radiation therapy.