RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug is a way to kill more tumor cells. PURPOSE: Phase I trial to study the effects of hydroxyurea plus combination chemotherapy in patients with non-small cell lung cancer.

OBJECTIVES: I. Estimate the maximum tolerated dose of hydroxyurea that can be given in combination with other chemotherapy regimens in patients with incurable non-small cell lung cancer. II. Determine the toxicity of this combination chemotherapy regimen in these patients. III. Observe the efficacy of hydroxyurea in patients with incurable non-small cell lung cancer refractory to front-line chemotherapy.

PROTOCOL OUTLINE: This study seeks to estimate the maximum tolerated dose (MTD) of hydroxyurea in combination with other chemotherapy. Groups of 3 patients take escalated doses of oral hydroxyurea three times weekly or daily throughout treatment with cisplatin plus (per their previous regimen) vinblastine, vindesine, vinorelbine, or etoposide. Treatment continues in responding and stable patients until 3 months beyond documentation of complete remission (minimum 4 courses), maximum of 6 courses beyond documentation of partial remission, or 3 courses beyond documentation of stable disease. Patients are followed every 3 weeks for 3 months, every 6 weeks for 3 months, then every 3 months until disease progression.

PROJECTED ACCRUAL: An anticipated 15-30 patients will be entered.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histopathologically proven non-small cell lung cancer that is incurable by surgery or radiotherapy; Brain metastases allowed
• Demonstrated resistance to prior chemotherapy required by 1 of the following: Tumor growth or recurrence while on treatment; Failure of tumor to shrink over 3 consecutive courses of treatment
• Measurable or evaluable disease
• Recovery from any treatment-limiting toxicity required

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: At least 3 weeks since myelosuppressive chemotherapy (6 weeks since nitrosoureas, mitomycin, or high-dose carboplatin)
• Endocrine therapy: Not specified
• Radiotherapy: At least 3 weeks since radiotherapy unless to a limb or limited treatment area
• Surgery: Not specified

--Patient Characteristics--

• Age: 18 and over
• Performance status: Zubrod 0-2
• Life expectancy: Greater than 12 weeks
• Hematopoietic: ANC at least 1,500; Platelets at least 100,000; Hemoglobin at least 10 g/dL
• Hepatic: Bilirubin less than 1.5 mg/dL (26 micromoles/L); AST/ALT less than 1.5 times normal
• Renal: Creatinine less than 1.6 mg/dL (150 micromoles/L)
• Cardiovascular: No uncontrolled hypertension or other cardiac disease; No myocardial infarction within 6 months
• Other: No uncontrolled diabetes; No active abuse of ethanol; No allergies to study medication; No active infection or other serious medical condition that precludes protocol treatment; No dementia or significantly altered mental status that precludes informed consent; No prior melanoma or malignancy of the following sites: Breast; Kidney; Thyroid; Salivary glands; Endometrium; No other second malignancy within 5 years except: Nonmelanomatous skin cancer; Carcinoma in situ of cervix
• No pregnant or nursing women; Effective contraception required of fertile women