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

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00028938

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

10.3

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Biological: epoetin alfa Drug: carboplatin Drug: paclitaxel Radiation: radiation therapy	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

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

Actual Study Start Date :

Jan 1, 2002

Actual Primary Completion Date :

Nov 10, 2002

Actual Study Completion Date :

Nov 10, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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