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An Open Label, Randomized, Multicenter, Phase II Study To Determine Hemoglobin Dose Response, Safety And Pharmacokinetic Profile Of Ro 50-3821 Given Subcutaneously Once Weekly Or Once Every 3 Weeks To Anemic Patients With Stage IIIB or IV Non-Small Cell Lung Carcinoma Receiving Antineoplastic Therapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Anemia, Lung Cancer

Thank you

Trial Information

An Open Label, Randomized, Multicenter, Phase II Study To Determine Hemoglobin Dose Response, Safety And Pharmacokinetic Profile Of Ro 50-3821 Given Subcutaneously Once Weekly Or Once Every 3 Weeks To Anemic Patients With Stage IIIB or IV Non-Small Cell Lung Carcinoma Receiving Antineoplastic Therapy


OBJECTIVES:

Primary

- Compare the hemoglobin dose response of anemic patients with stage IIIB or IV non-small
cell lung cancer receiving antineoplastic therapy treated with 6 different regimens of
Ro 50-3821.

Secondary

- Compare the safety profile of these regimens in these patients.

- Compare the pharmacokinetic profile of these regimens in these patients.

- Determine additional pharmacodynamic characteristics of these regimens in these
patients.

OUTLINE: This is a randomized, open-label, parallel, multicenter study. Patients are
randomized to 1 of 6 treatment arms. In all arms, patients begin study therapy on the first
day of a course of antineoplastic therapy.

- Arm I: Patients receive a lower dose of Ro 50-3821 subcutaneously (SC) once weekly.

- Arm II: Patients receive a medium dose of Ro 50-3821 SC once weekly.

- Arm III: Patients receive a higher dose of Ro 50-3821 SC once weekly.

- Arm IV: Patients receive a lower dose of Ro 50-3821 SC once every 3 weeks.

- Arm V: Patients receive a medium dose of Ro 50-3821 SC once every 3 weeks.

- Arm VI: Patients receive a higher dose of Ro 50-3821 SC once every 3 weeks. In all
arms, treatment continues for 12 weeks in the absence of unacceptable toxicity.

Patients are followed at 1 week.

PROJECTED ACCRUAL: A total of 210 patients (35 per treatment arm) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer

- Stage IIIB or IV

- Currently receiving first- or second-line antineoplastic therapy (must be scheduled
to receive therapy during the 12 weeks of study therapy)

- Antineoplastic therapy may include single agent or combination chemotherapy,
corticosteroids, or a combination of these agents

- Hemoglobin no greater than 11 g/dL

- Transfusion independent

- No known primary or metastatic CNS malignancy

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- More than 6 months

Hematopoietic

- See Disease Characteristics

- Platelet count 50,000-500,000/mm^3

- No functional iron deficiency* (e.g., transferrin saturation less than 20% OR serum
ferritin less than 100 ng/mL)

- No known hemolysis NOTE: *Concurrent iron supplementation to correct deficiency
allowed

Hepatic

- Not specified

Renal

- Creatinine no greater than 2.5 mg/dL

Cardiovascular

- No clinically significant hypertension

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other malignancy within the past 5 years except basal cell or squamous cell
carcinoma or carcinoma in situ of the cervix

- No acute or chronic bleeding requiring therapy within the past 3 months (e.g.,
patients with anemia caused by gastrointestinal bleeding)

- No known cyanocobalamin deficiency

- No known folic acid deficiency

- No acute infection or inflammatory disease (C-reactive protein greater than 50 mg/L)

- No known resistance to epoetin administration

- No newly diagnosed (i.e., within the past 6 months) or uncontrolled epilepsy

PRIOR CONCURRENT THERAPY:

Biologic therapy

- More than 8 weeks since prior recombinant human erythropoietin therapy or any other
erythropoiesis-stimulating drugs

Chemotherapy

- See Disease Characteristics

Endocrine therapy

- See Disease Characteristics

Radiotherapy

- More than 4 weeks since prior radiotherapy

Surgery

- Not specified

Other

- More than 4 weeks since prior red blood cell transfusion

- More than 30 days since prior investigational drugs or regimens

- No prior enrollment and randomization to this study

- No other concurrent investigational drugs or regimens

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care

Principal Investigator

John A. Glaspy, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000335429

NCT ID:

NCT00072059

Start Date:

July 2003

Completion Date:

Related Keywords:

  • Anemia
  • Lung Cancer
  • anemia
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • Anemia
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781