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.
- 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
- 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.
- Histologically or cytologically confirmed stage IIIA or IIIB non-small cell lung
- Squamous cell carcinoma
- Adenocarcinoma (including bronchoalveolar cell)
- Large cell anaplastic carcinoma (including giant and clear cell carcinomas)
- 18 and over
- Karnofsky 60-100%
- Not specified
- 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
- Bilirubin less than 1.5 mg/dL
- AST less than 2 times upper limit of normal
- Creatinine clearance at least 20 mL/min
- No uncontrolled hypertension
- FEV1 at least 0.8 L
- 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
PRIOR CONCURRENT THERAPY:
- At least 30 days since prior transfusion
- No prior epoetin alfa or experimental forms of epoetin alfa
- No prior chemotherapy for NSCLC
- Not specified
- No prior radiotherapy for NSCLC
- At least 2 weeks since prior thoracotomy
- No concurrent therapy for iron, folate, or B12 deficiency
- No other concurrent anti-cancer therapy