AnemiaPhase 2NCT00072059
Ro 50-3821 in Treating Anemia in Patients Receiving Antineoplastic Therapy for Stage IIIB or Stage IV Non-Small Cell Lung Cancer
A Phase 2 study testing methoxy polyethylene glycol epoetin beta in people with Anemia and Lung Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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 trial is studying six different regimens of Ro 50-3821 to compare how well they work in treating anemia in patients who… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Lung Cancer
- What is being tested?
- methoxy polyethylene glycol epoetin beta
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Feb 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
About this study
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
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 trial is studying six different regimens of Ro 50-3821 to compare how well they work in treating anemia in patients who are receiving antineoplastic therapy for stage IIIB or stage IV non-small cell lung cancer.
Read the 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 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.
- Conditions
- Anemia, Lung Cancer
- Being tested
- methoxy polyethylene glycol epoetin beta
- Keywords
- anemia, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
- Medical subject headings
- Anemia, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methoxy polyethylene glycol epoetin betaBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2003 (estimated)
- Study startJul 2003
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- John A. Glaspy, MD, MPH, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00072059
- Sponsor's protocol ID
- ROCHE-NA17101
- Other IDs
- UCLA-0303085, CDR0000335429
- Status last verified
- Jan 2005
- First submitted
- 4 Nov 2003
- Last updated
- 18 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00072059
- Acronym / sponsor ID
- ROCHE-NA17101
- Conditions
- Anemia, Lung Cancer
- Keywords
- anemia, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2003
- Study completion
- Feb 2005 (actual)
- First posted
- 6 Nov 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 trial is studying six different regimens of Ro 50-3821 to compare how well they work in treating anemia in patients who are receiving antineoplastic therapy for stage IIIB or stage IV non-small cell lung cancer.
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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methoxy polyethylene glycol epoetin beta | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A. Glaspy, MD, MPH principal investigator
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing methoxy polyethylene glycol epoetin beta in people with Anemia and Lung Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2013.