Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Ro 50-3821 in Treating Anemia in Patients Receiving Antineoplastic Therapy for Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Supportive care	Completed	18 and over	NCI, Pharmaceutical / Industry	UCLA-0303085 ROCHE-NA17101, NCT00072059

Objectives

Primary

1. 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

1. Compare the safety profile of these regimens in these patients.
2. Compare the pharmacokinetic profile of these regimens in these patients.
3. Determine additional pharmacodynamic characteristics of these regimens in these patients.

Entry 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

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

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/mm³
• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

John Glaspy, MD, MPH, Principal investigator		Ph: 310-794-4955; 888-798-0719

Registry Information
Official Title		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
Trial Start Date		2003-07-14
Registered in ClinicalTrials.gov		NCT00072059
Date Submitted to PDQ		2003-09-17
Information Last Verified		2005-01-21
NCI Grant/Contract Number		P30-CA16042

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