Clinical trial NCT00062062 (phase 2, status: completed)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: carboplatin, gefitinib, paclitaxel
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Eligibility 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