Trials Sponsors Conditions Drugs Pricing

Conditions

Anemia Lung Cancer

Keywords

anemiastage IIIB non-small cell lung cancerstage IV non-small cell lung cancerrecurrent non-small cell lung cancer

Interventions

methoxy polyethylene glycol epoetin betaBiological

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

Jonsson Comprehensive Cancer Center
Otherlead
National Cancer Institute (NCI)
NIHcollaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

MeSH Terms

Conditions

AnemiaLung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial 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 2003

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

February 2005

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations