NCT00028938

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may stimulate red blood cell production and prevent or treat anemia in patients who are undergoing radiation therapy and chemotherapy. It is not yet known if chemotherapy combined with radiation therapy is more effective with or without epoetin alfa in treating non-small cell lung cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of chemotherapy combined with radiation therapy with or without epoetin alfa in treating patients who have stage IIIA or stage IIIB non-small cell lung cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_3 lung-cancer

Timeline
Completed

Started Jan 2002

Shorter than P25 for phase_3 lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2002

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2002

Completed
8 months until next milestone

First Posted

Study publicly available on registry

July 1, 2003

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

10 months

First QC Date

January 4, 2002

Last Update Submit

September 7, 2021

Conditions

Lung Cancer

Keywords

squamous cell lung cancerlarge cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung canceradenocarcinoma of the lungbronchoalveolar cell lung cancer

Interventions

epoetin alfaBIOLOGICAL
carboplatinDRUG
paclitaxelDRUG
radiation therapyRADIATION

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed stage IIIA or IIIB non-small cell lung cancer (NSCLC) * Squamous cell carcinoma * Adenocarcinoma (including bronchoalveolar cell) * Large cell anaplastic carcinoma (including giant and clear cell carcinomas) PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Granulocyte count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin 11.0-15 g/dL * If hemoglobin is 11.0-11.9 g/dL then the following lab values are required: * Iron greater than 60 mcg/mL * Transferrin saturation greater than 20% * Ferritin at least 100 mg/mL * Iron binding capacity less than 400 mcg/dL * RBC folate normal * B12 normal Hepatic: * Bilirubin less than 1.5 mg/dL * AST less than 2 times upper limit of normal Renal: * Creatinine clearance at least 20 mL/min Cardiovascular: * No uncontrolled hypertension Pulmonary: * FEV1 at least 0.8 L Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known hypersensitivity to mammalian cell-derived products or human albumin * No other concurrent or prior malignancy within the past 2 years except non- melanoma skin cancers PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 30 days since prior transfusion * No prior epoetin alfa or experimental forms of epoetin alfa Chemotherapy: * No prior chemotherapy for NSCLC Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy for NSCLC Surgery: * At least 2 weeks since prior thoracotomy Other: * No concurrent therapy for iron, folate, or B12 deficiency * No other concurrent anti-cancer therapy

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

Sponsors & Collaborators

Study Sites (1)

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungAdenocarcinoma of LungAdenocarcinoma, Bronchiolo-Alveolar

Interventions

Epoetin AlfaCarboplatinPaclitaxelRadiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsCoordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesTherapeutics

Study Officials

  • Arthur William Blackstock, MD

    Wake Forest University Health Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2002

First Posted

July 1, 2003

Study Start

January 1, 2002

Primary Completion

November 10, 2002

Study Completion

November 10, 2002

Last Updated

September 9, 2021

Record last verified: 2021-09

Locations

US(1)