Status:
COMPLETED
Ro 50-3821 in Treating Anemia in Patients Receiving Antineoplastic Therapy for Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Anemia
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Ro 50-3821 may stimulate red blood cell production and treat anemia in patients who are receiving antineoplastic therapy for non-small cell lung cancer. PURPOSE: This randomized phase II t...
Detailed Description
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 R...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
February 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00072059
Start Date
July 1 2003
End Date
February 1 2005
Last Update
July 18 2013
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781