A Study of Neutropenia and Anemia Management in Patients With Solid Tumors Receiving Myelotoxic Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00883181
First received: April 16, 2009
Last updated: May 6, 2016
Last verified: May 2016
  Purpose
The primary objective was to describe the incidence of febrile neutropenia based on granulocyte-colony stimulating factor (G-CSF) use (primary, secondary, treatment, or no usage) in patients receiving myelotoxic chemotherapy.

Condition
Breast Cancer
Non-Small Cell Lung Cancer
Ovarian Cancer
Small Cell Lung Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Prospective Observational Study of Neutropenia and Anemia Management in Subjects With Solid Tumors Receiving Myelotoxic Chemotherapy

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Percentage of Participants With Febrile Neutropenia (FN) [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
    Febrile neutropenia was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm².

  • Percentage of Participants Who Received No Prophylaxis or Treatment With Granulocyte Colony-stimulating Factors (G-CSF) Who Experienced Febrile Neutropenia [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
    FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants in the No G-CSF use group received no G-CSF prophylaxis or treatment at any time during cycles 1 to 8.

  • Percentage of Participants Receiving Primary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
    FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis with pegfilgrastim was defined as receiving pegfilgrastim starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of Cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.

  • Percentage of Participants Receiving Primary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
    FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis was defined as receiving any daily G-CSF (e.g. filgrastim or lenograstim) starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.

  • Percentage of Participants Receiving Secondary Prophylaxis With Pegfilgrastim Who Experienced Febrile Neutropenia [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
    FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis with pegfilgrastim was defined as receiving pegfilgrastim starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of pegfilgrastim support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.

  • Percentage of Participants Receiving Secondary Prophylaxis With Any Daily G-CSF Who Experienced Febrile Neutropenia [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
    FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis was defined as receiving any daily G-CSF starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of G-CSF support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.

  • Percentage of Participants Receiving Primary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
    FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Primary prophylaxis was defined as receiving any other G-CSF starting in cycle 1 on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Participants who received G-CSF support from the beginning of cycle 1 were assigned to primary prophylaxis regardless of whether they continued to receive G-CSF support in subsequent cycles.

  • Percentage of Participants Receiving Secondary Prophylaxis With an Other G-CSF Who Experienced Febrile Neutropenia [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
    FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Secondary prophylaxis was defined as receiving any daily G-CSF starting in cycle 2 onwards on day 1 to 7 if chemotherapy completed by day 7 and day 1 to 11 if chemotherapy completed after day 7. Assignment to G-CSF use groups was programmatically derived rather than assigned by the investigator. Participants were assigned to a G-CSF use group that represented the 'best' G-CSF therapy they received at any point in the study. Adherence of G-CSF support in subsequent cycles was not required for secondary prophylaxis; just an initiation of G-CSF support in the beginning of cycle 2 or later. Results include the FN event that may have triggered the secondary prophylaxis treatment.

  • Percentage of Participants Receiving Treatment With Pegfilgrastim Who Experienced Febrile Neutropenia [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
    FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with pegfilgrastim is defined as participants who started pegfilgrastim treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.

  • Percentage of Participants Receiving Treatment With Any Daily G-CSF Who Experienced Febrile Neutropenia [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
    FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with any daily G-CSF is defined as participants who started daily G-CSF treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.

  • Percentage of Participants Receiving Treatment With Any Other G-CSF Who Experienced Febrile Neutropenia [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
    FN was defined as a single oral temperature ≥ 38.3°C, or a temperature of ≥ 38.0°C for ≥ 1 hour with a neutrophil count of < 500 cells/mm² or < 1000 cells/mm² and predicted to fall below 500 cells/mm². Treatment with any other G-CSF is defined as participants who started other G-CSF treatment after day 7 of any cycle if chemotherapy completed by day 7 and after day 11 of any cycle if chemotherapy completed after day 7.


Secondary Outcome Measures:
  • Number of Participants Who Received G-CSF During Cycles 1 to 8 [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
  • Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Pegfilgrastim [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
    The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles.

  • Number of Days of Prophylaxis in Participants Receiving Primary Prophylaxis With Any Daily G-CSF [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
    The average number of days of daily G-CSF use per cycle was calculated across all administered cycles.

  • Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Pegfilgrastim [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
    The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles.

  • Number of Days of Prophylaxis in Participants Receiving Secondary Prophylaxis With Any Daily G-CSF [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
    The average number of days of daily G-CSF use per cycle was calculated across all administered cycles.

  • Number of Days of Treatment in Participants Receiving Treatment With Pegfilgrastim [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
    The average number of days of pegfilgrastim use per cycle was calculated across all administered cycles.

  • Number of Days of Treatment in Participants Receiving Treatment With Any Daily G-CSF [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
  • Percentage of Participants With Chemotherapy Dose Delays in Cycles 2 Through 8 [ Time Frame: Cycles 2 - 8 (approximately 21 weeks) ] [ Designated as safety issue: No ]
    A dose delay is defined as a delay of more than 3 days in the start of chemotherapy measured since the start of the previous cycle. The percentage of participants with delays in chemotherapy administration are summarized by the length of delay (> 3 days, > 5 days, and > 7 days) across cycles 2 through 8.

  • Percentage of Cycles With Chemotherapy Dose Delays [ Time Frame: Cycles 2 - 8 (approximately 21 days) ] [ Designated as safety issue: No ]
    A dose delay is defined as a delay of > 3 days in the start of chemotherapy measured since the start of the previous cycle. The percentage of cycles delayed are summarized by the length of delay (> 3 days, > 5 days, and > 7 days) across cycles 2 through 8.

  • Percentage of Participants With Chemotherapy Dose Reductions [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
    A participant is considered to have a dose reduction in a given cycle if there was a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle.

  • Percentage of Cycles With Chemotherapy Dose Reductions [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
    A dose reduction in a given cycle is defined as a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle.

  • Reasons for Cycles With > 3 Days Chemotherapy Dose Delays in Cycles 2 to 8 [ Time Frame: Cycles 2 - 8 (approximately 21 weeks) ] [ Designated as safety issue: No ]
    A dose delay is defined as a delay of > 3 days in the start of chemotherapy measured since the start of the previous cycle.

  • Reasons for Cycles With ≥ 15% Chemotherapy Dose Reductions in Cycles 1-8 [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
    A dose reduction in a given cycle is defined as a ≥ 15% reduction in dose of any chemotherapy agent planned for that cycle, relative to the dose planned at the baseline visit for that cycle.

  • Number of Participants With Systemic Anti-infective Use in Cycles 1 to 8 [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
    Number of participants with systemic anti-infective use, including antibiotics, anti-fungal and virostatic for prophylaxis or treatment.

  • Number of Participants With Unplanned Hospitalizations [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
    Unplanned hospitalizations included only those which involved an overnight stay and occurred in cycles 1 to 8.

  • Investigator Assessed Clinical Response at End of Treatment [ Time Frame: End of treatment (approximately 24 weeks) ] [ Designated as safety issue: No ]
  • Number of Participants With Hematological Toxicities [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
    The number of participants experiencing treatment related grade 3 and 4 hematological toxicities during cycles 1 to 8. Participants experiencing both Grade 3 and Grade 4 toxicities are reported under Grade 4 only (maximum toxicity). Toxicity grades for hematology data are defined according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0: Absolute neutrophil count (ANC) - Grade 3: < 1.0 - 0.5 x 10^9/L; ANC - Grade 4: < 0.5 x 10^9/L; White blood cells (WBC) - Grade 3: < 2.0 - 1.0 x 10^9/L; WBC - Grade 4: < 1.0 x 10^9/L; Hemoglobin - Grade 3: < 8.0 - 6.5 g/dL; Hemoglobin - Grade 4: < 6.5 g/dL; Platelets - Grade 3: < 50 - 25 x 10^9/L; Platelets - Grade 4: < 25 x 10^9/L.

  • Time to Disease Progression [ Time Frame: From cycle 1, day 1 until end of the long-term follow-up; median time on follow-up from cycle 1, day 1 was 52 months. ] [ Designated as safety issue: No ]
    Time to disease progression was calculated from cycle 1 day 1 to a date at which disease progression was first recorded. Participants who died due to causes other than disease progression were censored at the date of death. Participants who were alive and whose disease had not progressed at the most recent contact, or who were lost to follow-up, or with missing data, were censored at the date of last contact. Median time to disease progression was estimated from the Kaplan-Meier survival function.

  • Duration of Treatment With Erythropoiesis-stimulating Agents (ESAs) [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
  • Reason for Treatment With Erythropoiesis-stimulating Agents [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
    The reason treatment with an ESA was initiated as recorded by the investigator; participants may have more than one reason for initiating treatment.

  • Hemoglobin Level at Initiation of Erythropoiesis-stimulating Agent Treatment [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
  • Number of Clinical Visits in Cycles 1-8 by ESA Use [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
    The average number of clinical visits per month (28 day period) during cycles 1 to 8 and during the period of ESA treatment in cycles 1 to 8.

  • Percentage of Participants Who Received ESAs and Required a Red Blood Cell (RBC) Transfusion After 5 Weeks of ESA Treatment [ Time Frame: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks. ] [ Designated as safety issue: No ]
    Kaplan-Meier estimate of the percentage of participants with RBC transfusions from five weeks post initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.

  • Change in Hemoglobin During ESA Treatment Phase [ Time Frame: Initiation of ESA treatment (last assessment on or prior to ESA day 1) and at end of ESA treatment; median duration of ESA treatment was 4 weeks, maximum was 23 weeks. ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Received ESAs and Achieved Hematopoietic Response [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
    Kaplan-Meier estimate of the percentage of participants in cycles 1 to 8 receiving ESA treatment who achieved a hematopoietic response during the ESA treatment phase, defined as a hemoglobin concentration ≥ 12 g/dL or a ≥ 2 g/dL rise in hemoglobin after starting ESA treatment.

  • Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 9 g/dL After 5 Weeks ESA Treatment [ Time Frame: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks. ] [ Designated as safety issue: No ]
    Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 9 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.

  • Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 10 g/dL After 5 Weeks ESA Treatment [ Time Frame: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks. ] [ Designated as safety issue: No ]
    Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 10 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.

  • Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 11 g/dL After 5 Weeks ESA Treatment [ Time Frame: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks. ] [ Designated as safety issue: No ]
    Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 11 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.

  • Percentage of Participants Who Received ESAs and Achieved Hemoglobin ≥ 12 g/dL After 5 Weeks ESA Treatment [ Time Frame: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks. ] [ Designated as safety issue: No ]
    Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level ≥ 12 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.

  • Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 10 to 12 g/dL After 5 Weeks ESA Treatment [ Time Frame: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks. ] [ Designated as safety issue: No ]
    Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level from 10 to 12 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.

  • Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 12 to 13 g/dL After 5 Weeks ESA Treatment [ Time Frame: From 5 weeks post initiation of ESA treatment to the end of ESA treatment phase (EOTP) during cycles 1 - 8; maximum duration of ESA treatment was 23 weeks. ] [ Designated as safety issue: No ]
    Kaplan-Meier estimate of the percentage of participants achieving a hemoglobin level from 12 to 13 g/dL during the period from five weeks after initiation of ESA treatment until the end of ESA treatment during cycles 1 to 8.

  • Percentage of Participants Who Received ESAs and Achieved Hemoglobin From 10 to 12 g/dL 9 Weeks After Initiation of ESA Treatment [ Time Frame: 9 weeks post initiation of ESA treatment ] [ Designated as safety issue: No ]
    The percentage of participants achieving a hemoglobin level from 10 to 12 g/dL after 9 weeks of ESA treatment.

  • Number of Participants With Systemic Transfusions in Cycles 1 to 8 [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]
    Number of participants who received transfusions, including platelets, packed red blood cells, whole blood, or other, during cycles 1 to 8.

  • Number of Transfusions Per Participant in Cycles 1 to 8 [ Time Frame: Cycles 1 - 8 (approximately 24 weeks) ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained
This is an observational study. No bio-specimens are being collected.

Enrollment: 1370
Study Start Date: December 2007
Study Completion Date: September 2014
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Detailed Description:

This is a multi-center international observational study of patients receiving myelotoxic regimens, with an investigator assessed risk of febrile neutropenia ≥ 20%, for the treatment of solid tumors (breast, ovarian and lung).

This is an observational study in which patient risk factors were qualitatively (but not quantitatively) assessed, and adherence to G-CSF primary prophylaxis was at the discretion of physicians and not mandated by the protocol.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Sites were selected based on where medical data of interest were routinely and completely collected. To avoid geographical bias, sites represented various types of treating centers within each country and sites were encouraged to provide data on patients within all tumor types.
Criteria

Inclusion Criteria:

  • Subjects greater than or equal to 18 years old with breast, ovarian or lung cancer receiving chemotherapy in any schedule, e.g. dose dense or standard chemotherapy.
  • These subjects must have an Investigator assessed risk of febrile neutropenia (FN) ≥20% (based on 2006 European Organisation for Research and Treatment of Cancer (EORTC) G-CSF Guidelines

Exclusion Criteria:

- Subjects with concurrent administration of radiotherapy are not eligible (previous radiotherapy is permitted if terminated at least 2 weeks prior to commencing applicable chemotherapy in this study).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00883181

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00883181     History of Changes
Other Study ID Numbers: 20060445 
Study First Received: April 16, 2009
Results First Received: March 10, 2016
Last Updated: May 6, 2016
Health Authority: Australia: Human Research Ethics Committee
Canada: Health Canada
Czech Republic: State Institute of Drug Control
Finland: Lääkelaitos
Greece: National Organization for Medicines
Italy: Ministry of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Switzerland: Swissmedic (Swiss Agency for Therapeutic Products)

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Neutropenia
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on July 28, 2016