Trial Outcomes & Findings for G-CSF and Pegfilgrastim in Treating Neutropenia in Patients Undergoing Radiation Therapy and Chemotherapy for Limited Stage Small Cell Lung Cancer (NCT NCT00554463)

NCT ID: NCT00554463

Last Updated: 2019-05-29

Results Overview

Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. No testing was done due to early study termination.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: From start of treatment to end of concurrent chemoradiation, for a maximum of 45 days
• Results posted on: 2019-05-29

Participant Flow

Participant milestones

Measure	Combined Modality Therapy With Growth Factor Support Concurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

G-CSF and Pegfilgrastim in Treating Neutropenia in Patients Undergoing Radiation Therapy and Chemotherapy for Limited Stage Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Combined Modality Therapy With Growth Factor Support n=5 Participants Concurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim.
Age, Continuous	67 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: From start of treatment to end of concurrent chemoradiation, for a maximum of 45 days

Population: All registered patients

Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. No testing was done due to early study termination.

Outcome measures

Measure	Combined Modality Therapy With Growth Factor Support n=5 Participants Concurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim.
Number of Patients With Grade 3-4 Febrile Neutropenia During Concurrent Chemoradiotherapy	0 Participants

SECONDARY outcome

Timeframe: From the start to the end of adjuvant chemotherapy, a maximum of 24 days

Population: All registered patients

Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.

Outcome measures

Measure	Combined Modality Therapy With Growth Factor Support n=5 Participants Concurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim.
Number of Patients With Grade 3-4 Febrile Neutropenia During Adjuvant Chemoradiotherapy	1 Participants

SECONDARY outcome

Timeframe: From start of treatment to end of treatment, for a maximum of 66 days

Population: All registered patients

Outcome measures

Measure	Combined Modality Therapy With Growth Factor Support n=5 Participants Concurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim.
Number of Patients With Dose Modifications or Treatment Delays	2 Participants

SECONDARY outcome

Timeframe: From registration to last follow-up, a maximum of 32.9 months

Population: All registered patients

Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. No testing was done due to early study termination.

Outcome measures

Measure	Combined Modality Therapy With Growth Factor Support n=5 Participants Concurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim.
Number of Patients With Grade 3+ Esophagitis, Pneumonitis, and Other Non-hematological Adverse Events Grade 3+ Esophagitis	0 Participants
Number of Patients With Grade 3+ Esophagitis, Pneumonitis, and Other Non-hematological Adverse Events Grade 3+ Pneumonitis	1 Participants
Number of Patients With Grade 3+ Esophagitis, Pneumonitis, and Other Non-hematological Adverse Events Grade 3+ Other non-hematologic	1 Participants

SECONDARY outcome

Timeframe: From registration to last follow-up, a maximum of 32.9 months

Population: All registered patients

Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.

Outcome measures

Measure	Combined Modality Therapy With Growth Factor Support n=5 Participants Concurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim.
Number of Patients With Grade 4 Thrombocytopenia	0 Participants

SECONDARY outcome

Timeframe: From registration to last follow-up, a maximum of 32.9 months

Population: All registered patients

Overall survival time is defined as time from registration/randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Due to early termination with few patients, only counts of events have been calculated.

Outcome measures

Measure	Combined Modality Therapy With Growth Factor Support n=5 Participants Concurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim.
Overall Survival	3 Participants

SECONDARY outcome

Timeframe: From registration to last follow-up, a maximum of 32.9 months

Population: All registered patients

Progression is defined as any failure per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Progression-free survival time is defined as time from registration to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. Due to early termination with few patients, only counts of events have been calculated.

Outcome measures

Measure	Combined Modality Therapy With Growth Factor Support n=5 Participants Concurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim.
Progression-free Survival	3 Participants

Adverse Events

Combined Modality Therapy With Growth Factor Support

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Combined Modality Therapy With Growth Factor Support n=5 participants at risk Concurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim.
Blood and lymphatic system disorders Blood disorder	20.0% 1/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Blood and lymphatic system disorders Febrile neutropenia	20.0% 1/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Blood and lymphatic system disorders Hemoglobin decreased	20.0% 1/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Fatigue	20.0% 1/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Sepsis [with Grade 3-4 ANC]	20.0% 1/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Neutrophil count decreased	20.0% 1/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Neurological disorder NOS	20.0% 1/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Atelectasis	20.0% 1/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Pneumonitis	40.0% 2/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.

Other adverse events

Measure	Combined Modality Therapy With Growth Factor Support n=5 participants at risk Concurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim.
Cardiac disorders Atrial flutter	20.0% 1/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Pericardial effusion	20.0% 1/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Sinus tachycardia	20.0% 1/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Abdominal pain	20.0% 1/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Constipation	20.0% 1/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Dysphagia	40.0% 2/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Esophagitis	60.0% 3/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Gastrointestinal disorder	20.0% 1/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Nausea	60.0% 3/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Salivary gland disorder	20.0% 1/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Fatigue	60.0% 3/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Bronchitis [with Grade 3-4 ANC]	20.0% 1/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Sepsis [with unknown ANC]	20.0% 1/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Neutrophil count decreased	40.0% 2/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Platelet count decreased	40.0% 2/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Bone pain	20.0% 1/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Muscle weakness	20.0% 1/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Pain in extremity	20.0% 1/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Dizziness	20.0% 1/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Headache	20.0% 1/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Insomnia	20.0% 1/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 1/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Dyspnea	20.0% 1/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Pneumonitis	40.0% 2/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	20.0% 1/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Alopecia	20.0% 1/5 Patients experiencing more than one of a given adverse event are counted only once for that adverse event.

Additional Information

Wendy Seiferheld

NRG Onocology

Email: wseiferheld@nrgonology.org

Results disclosure agreements

• Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
• Publication restrictions are in place

Restriction type: OTHER