Ro 50-3821 in Treating Anemia in Patients Receiving Antineoplastic Therapy for Stage IIIB or Stage IV Non-Small Cell Lung Cancer

OBJECTIVES:

Primary

• Compare the hemoglobin dose response of anemic patients with stage IIIB or IV non-small cell lung cancer receiving antineoplastic therapy treated with 6 different regimens of Ro 50-3821.

Secondary

• Compare the safety profile of these regimens in these patients.
• Compare the pharmacokinetic profile of these regimens in these patients.
• Determine additional pharmacodynamic characteristics of these regimens in these patients.

OUTLINE: This is a randomized, open-label, parallel, multicenter study. Patients are randomized to 1 of 6 treatment arms. In all arms, patients begin study therapy on the first day of a course of antineoplastic therapy.

• Arm I: Patients receive a lower dose of Ro 50-3821 subcutaneously (SC) once weekly.
• Arm II: Patients receive a medium dose of Ro 50-3821 SC once weekly.
• Arm III: Patients receive a higher dose of Ro 50-3821 SC once weekly.
• Arm IV: Patients receive a lower dose of Ro 50-3821 SC once every 3 weeks.
• Arm V: Patients receive a medium dose of Ro 50-3821 SC once every 3 weeks.
• Arm VI: Patients receive a higher dose of Ro 50-3821 SC once every 3 weeks. In all arms, treatment continues for 12 weeks in the absence of unacceptable toxicity.

Patients are followed at 1 week.

PROJECTED ACCRUAL: A total of 210 patients (35 per treatment arm) will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer

• Stage IIIB or IV
• Currently receiving first- or second-line antineoplastic therapy (must be scheduled to receive therapy during the 12 weeks of study therapy)

• Antineoplastic therapy may include single agent or combination chemotherapy, corticosteroids, or a combination of these agents
• Hemoglobin no greater than 11 g/dL

• Transfusion independent
• No known primary or metastatic CNS malignancy

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 6 months

Hematopoietic

• See Disease Characteristics
• Platelet count 50,000-500,000/mm^3
• No functional iron deficiency* (e.g., transferrin saturation less than 20% OR serum ferritin less than 100 ng/mL)
• No known hemolysis NOTE: *Concurrent iron supplementation to correct deficiency allowed

Hepatic

• Not specified

Renal

• Creatinine no greater than 2.5 mg/dL

Cardiovascular

• No clinically significant hypertension

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other malignancy within the past 5 years except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix
• No acute or chronic bleeding requiring therapy within the past 3 months (e.g., patients with anemia caused by gastrointestinal bleeding)
• No known cyanocobalamin deficiency
• No known folic acid deficiency
• No acute infection or inflammatory disease (C-reactive protein greater than 50 mg/L)
• No known resistance to epoetin administration
• No newly diagnosed (i.e., within the past 6 months) or uncontrolled epilepsy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 8 weeks since prior recombinant human erythropoietin therapy or any other erythropoiesis-stimulating drugs

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• More than 4 weeks since prior radiotherapy

Surgery

• Not specified

Other

• More than 4 weeks since prior red blood cell transfusion
• More than 30 days since prior investigational drugs or regimens
• No prior enrollment and randomization to this study
• No other concurrent investigational drugs or regimens