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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Arthur William Blackstock, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Federal Government

Study ID:

CDR0000069148

NCT ID:

NCT00028938

Start Date:

January 2002

Completion Date:

Related Keywords:

  • Lung Cancer
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082