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Chemotherapy and Radiation Therapy With or Without Epoetin Alfa in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
This study has been completed.

First Received on January 4, 2002.   Last Updated on August 20, 2009   History of Changes
Sponsor: Wake Forest University Baptist Medical Center
Collaborator: National Cancer Institute (NCI)
Information provided by: Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier: NCT00028938
  Purpose

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.


Condition Intervention Phase
Lung Cancer
 Biological: epoetin alfa
Drug: carboplatin
Drug: paclitaxel
Radiation: radiation therapy
 Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Phase III Randomized Trial Evaluating the Effect of Epoetin Alfa (Procrit) on Local Control in Patients Undergoing Concurrent Chemotherapy and Radiation Therapy for Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Erythropoietin Paclitaxel Carboplatin Epoetin alfa
U.S. FDA Resources

Further study details as provided by Wake Forest University Baptist Medical Center:

Study Start Date: January 2002
Detailed Description:

OBJECTIVES:

  • Determine the efficacy of epoetin alfa in maintaining hemoglobin levels in patients with stage IIIA or IIIB non-small cell lung cancer when treated with chemoradiotherapy.
  • Compare the time to local and systemic progression in patients receiving chemoradiotherapy with or without epoetin alfa.
  • Compare tumor response rate and overall survival in patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Compare quality of life in patients treated with these regimens.
  • Compare the number of transfusions in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Karnofsky performance status (90-100% vs 60-80%), weight loss (no more than 5% vs 6-10%), and baseline hemoglobin (women 11.0-12.4 g/dL and men 11.0-13.4 g/dL vs women 12.5-15.0 g/dL and men 13.5-15.0 g/dL). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Beginning 7-10 days before the start of chemoradiotherapy, patients receive epoetin alfa subcutaneously once weekly for 8 weeks. Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once weekly for 7 weeks. Patients undergo radiotherapy 5 days a week for 7 weeks for a total of 33 treatments. Treatment continues in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive paclitaxel, carboplatin, and radiotherapy as in arm I. Quality of life is assessed at baseline, at completion of chemoradiotherapy, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 202-232 patients (101-116 per treatment arm) will be accrued for this study within 1.7-2 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00028938

Locations
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
Sponsors and Collaborators
Wake Forest University Baptist Medical Center
National Cancer Institute (NCI)
Investigators
Study Chair: Arthur William Blackstock, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00028938     History of Changes
Other Study ID Numbers: CDR0000069148, CCCWFU-62299, CCCWFU-BG01-193, NCI-P01-0200
Study First Received: January 4, 2002
Last Updated: August 20, 2009
Health Authority: United States: Federal Government

Keywords provided by Wake Forest University Baptist Medical Center:
squamous cell lung cancer
large cell lung cancer
stage IIIA non-small cell lung cancer
 stage IIIB non-small cell lung cancer
adenocarcinoma of the lung
bronchoalveolar cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Epoetin Alfa
Carboplatin
 Paclitaxel
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 09, 2012



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