Parallel Phase II Trials of ZD1839 (Iressa) Alone or Weekly Carboplatin and Paclitaxel Followed by ZD1839 (Iressa) (Oncologists Must Choose) for Metastatic Non-Small Cell Lung Cancer in Patients > or = 65 Years of Age

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

- Metastatic or unresectable disease

- Measurable disease

- At least 1 lesion at least 2.0 cm

- Disease must be completely outside prior radiotherapy port OR documented disease
progression since the completion of radiotherapy

- No meningeal carcinomatosis

- No untreated brain metastases

- Current metastatic CNS disease must have been treated and clinically stable for
at least 2 weeks prior to study chemotherapy

- No potentially curative treatment options available (e.g., chemotherapy with surgery
or radiotherapy)

PATIENT CHARACTERISTICS:

Age

- 65 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 12 weeks

Hematopoietic

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 10.0 g/dL

Hepatic

- Bilirubin no greater than 2.0 mg/dL

- No uncontrolled hepatic disease

Renal

- Creatinine no greater than 2 times upper limit of normal

- No uncontrolled renal disease

Cardiovascular

- No uncontrolled cardiac disease

Pulmonary

- No clinically active interstitial lung disease

- Asymptomatic, chronic stable radiographic changes allowed

- No uncontrolled respiratory disease

Other

- Fertile patients must use effective contraception

- Able and willing to complete questionnaires alone or with assistance

- No known hypersensitivity to gefitinib or any of its excipients

- No active infection within the past 2 weeks

- No other prior malignancy within the past 5 years except basal cell skin cancer

- No grade 2 or greater peripheral neuropathy (CTC v2.0)

- No uncontrolled diabetes mellitus (for patients receiving study chemotherapy)

- No dysphagia or inability to swallow intact capsules

- No significant medical condition that would preclude study treatment or follow-up

- No severe or uncontrolled systemic disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

- No prior chemotherapy for metastatic NSCLC

Endocrine therapy

- Concurrent steroids allowed provided the dose is not changed

Radiotherapy

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered

- No prior radiotherapy to more than 25% of marrow-containing skeleton

- No concurrent radiotherapy (including palliative)

Surgery

- See Disease Characteristics

- At least 3 weeks since prior major surgery

- No surgery within 7 days after study participation

Other

- More than 30 days since prior non-FDA approved investigational drugs

- No concurrent oral retinoids

- No concurrent CYP3A4-inducing agents, including the following:

- Carbamazepine

- Oxcarbazepine

- Modafinil

- Ethosuximide

- Griseofulvin

- Nafcillin

- Phenobarbital

- Phenylbutazone

- Phenytoin

- Primidone

- Rifampin

- Hypericum perforatum (St. John's wort)

- Barbiturates

- Sulfinpyrazone

- No concurrent drugs that cause sustained elevation of gastric pH (≥ 5)

- No concurrent antacids within 4 hours before, during, and within 4 hours after
gefitinib administration

- No concurrent itraconazole, fluconazole, ketoconazole, or erythromycin