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

NCT00072059 | Completed Phase 2

• 3 other identifiers: ROCHE-NA17101UCLA-0303085CDR0000335429
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anemia; Lung Cancer

Keywords

anemia; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer

Interventions

methoxy polyethylene glycol epoetin beta BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Anemia; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• John A. Glaspy, MD, MPH

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 4, 2003
• First Posted: November 6, 2003
• Study Start: July 1, 2003
• Study Completion: February 1, 2005
• Last Updated: July 18, 2013

Record last verified: 2005-01

Locations

US (1)