Chemotherapy and Radiation Therapy With or Without Epoetin Alfa in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer - Full Text View

Sponsors and Collaborators:	Wake Forest University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
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:	Treatment, Randomized, Active Control
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 Radiation Therapy

Drug Information available for: Erythropoietin Paclitaxel Carboplatin Epoetin alfa

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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

National Cancer Institute (NCI)

Investigators

Study Chair:

Arthur William Blackstock, MD

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

Study ID Numbers:	CDR0000069148, CCCWFU-62299, CCCWFU-BG01-193, NCI-P01-0200
Study First Received:	January 4, 2002
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00028938 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Epoetin Alfa
Thoracic Neoplasms
Hematinics
Adenocarcinoma, Bronchiolo-Alveolar
Antimitotic Agents
Carboplatin
Carcinoma
Respiratory Tract Diseases
Lung Neoplasms

Paclitaxel
Lung Diseases
Tubulin Modulators
Non-small Cell Lung Cancer
Adenocarcinoma of Lung
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Epoetin Alfa
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hematinics
Mitosis Modulators
Hematologic Agents
Antimitotic Agents
Carboplatin
Pharmacologic Actions

Carcinoma
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009