A Study of Subjects With Previously Untreated Extensive-Stage Small-Cell Lung Cancer (SCLC) Treated With Platinum Plus Etoposide Chemotherapy With or Without Darbepoetin Alfa
This study has been completed.
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00119613
First received: July 7, 2005
Last updated: August 7, 2008
Last verified: August 2008
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Purpose
The purpose of this study is to evaluate whether increasing or maintaining hemoglobin concentrations with darbepoetin alfa, when administered with platinum-containing chemotherapy in subjects with previously untreated extensive-stage small cell lung cancer (SCLC), increases survival.
| Condition | Intervention | Phase |
|---|---|---|
|
Small Cell Lung Cancer |
Drug: placebo Drug: darbepoetin alfa |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double Blind, Placebo-Controlled Study of Subjects With Previously Untreated Extensive-Stage Small-Cell Lung Cancer (SCLC) Treated With Platinum Plus Etoposide Chemotherapy With or Without Darbepoetin Alfa |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Change in hemoglobin concentration from baseline to the end of the chemotherapy treatment period [ Time Frame: from baseline to the end of the chemotherapy treatment period ] [ Designated as safety issue: No ]
- Survival time [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change in FACT-fatigue subscale scores from baseline to the end of study treatment [ Time Frame: from baseline to the end of study treatment ] [ Designated as safety issue: No ]
- Incidence of Adverse Events (including serious and treatment related) [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- Changes in laboratory values, changes in vital signs and incidence of concomitant medications [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 600 |
| Study Start Date: | December 2002 |
| Study Completion Date: | April 2007 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1 - darbepoetin alfa
Darbepoetin alfa 300 mcg QW for the first 4 weeks, followed by Q3W dosing commencing on week 5 for the remainder of the treatment period.
|
Drug: darbepoetin alfa
darbepoetin alfa
|
|
Placebo Comparator: Group 2 - Placebo
Placebo QW for the first 4 weeks, followed by Q3W dosing commencing on week 5 for the remainder of the treatment period.
|
Drug: placebo
placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Pathologically proven SCLC, extensive-stage
- Planned to receive chemotherapy of carboplatin or cisplatin plus etoposide every 3 weeks for 6 cycles
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy greater than or equal to 3 months
- Hemoglobin concentration greater than or equal to 9.0 g/dL and less than or equal to 13g/dL
- Adequate renal, liver and hematopoietic function
- Subjects must sign and date a written Institutional Review Board /Independent Ethics Committee-approved Informed Consent Form
Exclusion Criteria:
- Known primary hematologic disorder which could cause anemia
- Brain metastases that are either symptomatic or treated with medications
- Unstable or uncontrolled disease/condition, related to or affecting cardiac function
- Other known primary malignancy within the past 5 years with the exception of curatively treated basal cell carcinoma, squamous cell carcinoma in situ cervical carcinoma or surgically cured malignancies
- Iron deficiency
- Known positive test for human immunodeficiency virus infection
- Received greater than 2 units of packed red blood cells within 4 weeks of randomization or any RBC transfusions within 2 weeks before randomization
- Received rHuEPO or darbepoetin alfa therapy within 4 weeks of randomization
- Previous chemotherapy for SCLC
- Previous radiotherapy except as symptom palliation for bone or brain lesions and at least 24 hours since prior radiotherapy for symptom palliation providing extent of radiotherapy makes marked bone marrow suppression unlikely
- Less than 30 days since receipt of any drug or device that is not approved for any indication
- Pregnant or breast-feeding
- Not using adequate contraceptive precautions
- Previously randomized into this study
- Known hypersensitivity to recombinant mammalian-derived product or any other ingredients contained in the study drug
- Any medical, mental, or other conditions that makes the subject unsuitable for participation
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00119613 History of Changes |
| Other Study ID Numbers: | 20010145 |
| Study First Received: | July 7, 2005 |
| Last Updated: | August 7, 2008 |
| Health Authority: | Switzerland: Agency for Therapeutic Products Turkey: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration Romania: Ministry of Health and the Family Australia: Therapeutic Goods Administration Austria: Bundesamt für Sicherheit im Gesundheitswesen Belgium: Service Public Federal Sante Publiquest, Securite de la Chaine alimentaire et Environnement Canada: Health Canada Czech Republic: Statni ustav pro kontrolu leciv Denmark: Laegemiddelstyrelsen Estonia: State Agency of Medicines Finland: Lääkelaitos Germany: Federal Institute for Drugs and Medical Devices Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe Hungary: National Institute of Pharmacy Ireland: Irish Medicines Board Italy: Ministry of Health Lithuania: State Medicines Control Agency of Lithuania Netherlands: Medicines Evaluation Board Netherlands: Medisch Centrum Rijnmond_Zuid, lcatie Zuider Poland: Drug Institut Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Portugal: Instituto Nacional da Farmácia e do Medicamento (INFARMED) Slovakia: Štátny ústav pre kontrolu lieciv Spain: Agencia Española de Medicamentos y Productos Sanitarios Sweden: Medical Products Agency |
Keywords provided by Amgen:
|
Oncology Clinical Trial Hemoglobin Darbepoetin alfa Survival |
Carboplatin Cisplatin Etoposide Extensive Stage Small Cell Lung Cancer |
Additional relevant MeSH terms:
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Etoposide Etoposide phosphate Darbepoetin alfa Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Hematinics Hematologic Agents |
ClinicalTrials.gov processed this record on May 21, 2013