Taxotere study

Phase II Study of Taxotere + Iressa in Previously Untreated Elderly (> or = 70 Years) Patients with Stage IIIb (with Malignant Pleural Effusion (MPE+)) or IV Non-Small Cell Lung Cancer (NSCLC)

Type of Cancer/Major Organ System:

Primary Contact: Vicki Trallo

Phone #: ()

Hypothesis: Primary clinical objectives are (1) To determine the response rate for Elderly (>=70 Years) previously untreated patients with stage IIIb or IV non-small cell lung cancer receiving Taxotere (docetaxel) + Iressa. (2) To evaluate the toxicity profile and overall survival in this same patient population.

Eligibility:

1. Subjects must be >= 70 years of age.
2. Subjects must have a histologically confirmed non-small cell lung cancer that is Stage IIIb (with pleural effusions) or Stage IV.
3. Subjects must be previously untreated for metastatic disease but may have received previous adjuvant chemotherapy more than six months prior to registration. Subjects may also have received radiation therapy for advanced disease; however, there should be measurable disease outside the radiation ports.
4. Disease must be unidimensionally measurable. Lesions which are located within a previously irradiated field are not considered measurable.
5. Subjects must have a life expectancy of at least 12 weeks and an ECOG performance status of 0 or 1.
6. Laboratory values must be as follows: White blood cell count>= 3,000/mm(3)Absolute neutrophil count>= 1,500/mm(3)Platelets>=100,000/mm(3)Total bilirubin<= 1.0 x institutional ulnserum creatinine<=2 x institutional ulnast or alt<=1.5 x institutional ulnalkaline phosphatase <=1.5 x institutional ulnserum calcium<=1.5 x institutional uln (corrected for werum albumin)subjects with combined alkaline phosphatase, ast and/or alt elevations will not be allowed to enroll on protocol.
7. Subjects must have recovered from all acute toxicities from previous therapy excluding alopecia.
8. Subjects must sign an informed consent form indicating that they are aware of the investigational nature of this study in keeping with the policies of the institution.
9. Subjects with stable brain metastases after completion of radiation will be allowed to enroll in this trial.
10. Subjects treated with adjuvant therapy more than six months ago will be allowed to enroll in this trial.

Exclusion:

1. Subjects previously treated with Taxotere or Iressa.
2. Subjects with known or clinical evidence of active Central Nervous System metastasis. Subjects with stable brain metastases will be allowed.
3. Male subjects with female sexual partners in the reproductive age group who refuse to use contraception are not eligible from the trial.
4. Subjects with concurrent serious infections (i.e., receiving an intravenous antibiotic) are not eligible.
5. Subjects with an unstable or serious concurrent medical condition are not eligible. 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.
6. Subjects receiving other investigational therapy concurrently.
7. Subjects 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. Subjects with a history of other cancers must have histological confirmation that current disease is compatible with diagnosis of NSCLC.
8. Peripheral neuropathy must be <= grade 1.
9. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Docetaxel, ZD1839, Polysorbate 80, or other agents used in the study.
10. Subjects with combined alkaline phosphatase, AST and/or ALT elevations will be ineligible for this protocol.