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

Jonsson Comprehensive Cancer Center

Status and phase

Completed

Phase 2

Conditions

Anemia

Lung Cancer

Treatments

Biological: methoxy polyethylene glycol epoetin beta

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00072059

CDR0000335429 (Registry Identifier)

ROCHE-NA17101

UCLA-0303085

Details and patient eligibility

About

RATIONALE: Ro 50-3821 may stimulate red blood cell production and treat anemia in patients who are receiving antineoplastic therapy for non-small cell lung cancer.

PURPOSE: This randomized phase II trial is studying six different regimens of Ro 50-3821 to compare how well they work in treating anemia in patients who are receiving antineoplastic therapy for stage IIIB or stage IV non-small cell lung cancer.

Full description

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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