Trial Outcomes & Findings for A Trial of Amrubicin and Carboplatin With Pegfilgrastim in Patients With Extensive-Stage Small Cell Lung Cancer (NCT NCT01076504)
NCT ID: NCT01076504
Last Updated: 2016-05-05
Results Overview
Percentage of patients still alive one year after their first treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
81 participants
Primary outcome timeframe
12 months
Results posted on
2016-05-05
Participant Flow
81 patients were enrolled but 1 patient was hospitalized prior to receiving any protocol treatment and was never treated. 80 patients included in the analysis
Participant milestones
| Measure |
Amrubicin/Carboplatin With Pegfilgrastim
Systemic therapy
Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle
Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle
Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle
|
|---|---|
|
Overall Study
STARTED
|
80
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
80
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial of Amrubicin and Carboplatin With Pegfilgrastim in Patients With Extensive-Stage Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Amrubicin/Carboplatin With Pegfilgrastim
n=80 Participants
Systemic therapy
Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle
Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle
Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle
|
|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: All enrolled and treated patients
Percentage of patients still alive one year after their first treatment
Outcome measures
| Measure |
Amrubicin/Carboplatin With Pegfilgrastim
n=80 Participants
Systemic therapy
Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle
Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle
Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle
|
|---|---|
|
1-year Survival
|
38 percentage of participants
Interval 25.0 to 50.0
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: Includes all patients who were treated and evaluated for response (74 patients - 6 were deemed not evaluable)
The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
Outcome measures
| Measure |
Amrubicin/Carboplatin With Pegfilgrastim
n=74 Participants
Systemic therapy
Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle
Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle
Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle
|
|---|---|
|
Objective Response Rate
|
80 percentage of evaluable participants
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: Includes all enrolled and treated patients
Time to progression will be defined as the time from first treatment until objective tumor progression (PD). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Amrubicin/Carboplatin With Pegfilgrastim
n=80 Participants
Systemic therapy
Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle
Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle
Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle
|
|---|---|
|
Time to Progression
|
23 weeks
Interval 1.4 to 104.4
|
SECONDARY outcome
Timeframe: 84 monthsPopulation: All enrolled and treated patients
The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Outcome measures
| Measure |
Amrubicin/Carboplatin With Pegfilgrastim
n=80 Participants
Systemic therapy
Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle
Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle
Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle
|
|---|---|
|
Overall Survival
|
10.3 months
Interval 8.5 to 13.0
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: All enrolled and treated patients
Grade 3/4 toxicities
Outcome measures
| Measure |
Amrubicin/Carboplatin With Pegfilgrastim
n=80 Participants
Systemic therapy
Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle
Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle
Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle
|
|---|---|
|
Toxicity/Safety
Anemia
|
22 participants
|
|
Toxicity/Safety
Leukopenia
|
30 participants
|
|
Toxicity/Safety
Thrombocytopenia
|
36 participants
|
|
Toxicity/Safety
Neutropenia
|
29 participants
|
|
Toxicity/Safety
Febrile neutropenia
|
10 participants
|
|
Toxicity/Safety
Hypokalemia
|
14 participants
|
|
Toxicity/Safety
Fatigue
|
11 participants
|
|
Toxicity/Safety
Dehydration
|
8 participants
|
|
Toxicity/Safety
Infection
|
11 participants
|
|
Toxicity/Safety
Hyponatremia
|
10 participants
|
|
Toxicity/Safety
Nausea
|
8 participants
|
|
Toxicity/Safety
Vomiting
|
6 participants
|
|
Toxicity/Safety
Hyperglycemia
|
3 participants
|
|
Toxicity/Safety
Muscle weakness
|
4 participants
|
|
Toxicity/Safety
Thrombosis/embolism
|
3 participants
|
Adverse Events
Amrubicin/Carboplatin With Pegfilgrastim
Serious events: 0 serious events
Other events: 80 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Amrubicin/Carboplatin With Pegfilgrastim
n=80 participants at risk
Systemic therapy
Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle
Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle
Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle
|
|---|---|
|
Immune system disorders
Allergic reaction
|
100.0%
80/80 • 18 months
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
80/80 • 18 months
|
|
Metabolism and nutrition disorders
ANOREXIA
|
100.0%
80/80 • 18 months
|
|
Gastrointestinal disorders
CONSTIPATION
|
100.0%
80/80 • 18 months
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
100.0%
80/80 • 18 months
|
|
Gastrointestinal disorders
DIARRHEA
|
100.0%
80/80 • 18 months
|
|
Nervous system disorders
Dizziness
|
100.0%
80/80 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
100.0%
80/80 • 18 months
|
|
General disorders
FATIGUE
|
100.0%
80/80 • 18 months
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
100.0%
80/80 • 18 months
|
|
General disorders
Fever
|
100.0%
80/80 • 18 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, stomatitis
|
100.0%
80/80 • 18 months
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
100.0%
80/80 • 18 months
|
|
Infections and infestations
Infections and infestations - Other, pneumonia
|
100.0%
80/80 • 18 months
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
100.0%
80/80 • 18 months
|
|
Gastrointestinal disorders
NAUSEA
|
100.0%
80/80 • 18 months
|
|
Investigations
Neutrophil count decreased
|
100.0%
80/80 • 18 months
|
|
General disorders
PAIN
|
100.0%
80/80 • 18 months
|
|
Investigations
Platelet count decreased
|
100.0%
80/80 • 18 months
|
|
Gastrointestinal disorders
VOMITING
|
100.0%
80/80 • 18 months
|
|
Investigations
Weight loss
|
100.0%
80/80 • 18 months
|
|
Investigations
White blood cell decreased
|
100.0%
80/80 • 18 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
43.8%
35/80 • 18 months
|
|
Musculoskeletal and connective tissue disorders
generalized muscle weakness
|
38.8%
31/80 • 18 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
36.2%
29/80 • 18 months
|
|
Metabolism and nutrition disorders
hyperglycemia
|
32.5%
26/80 • 18 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
31.2%
25/80 • 18 months
|
|
Investigations
Alkaline phosphatase increased
|
28.7%
23/80 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
20/80 • 18 months
|
|
Psychiatric disorders
Insomnia
|
22.5%
18/80 • 18 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
21.2%
17/80 • 18 months
|
|
General disorders
edema limbs
|
20.0%
16/80 • 18 months
|
|
Vascular disorders
Hypotension
|
20.0%
16/80 • 18 months
|
|
Investigations
Blood bilirubin increased
|
18.8%
15/80 • 18 months
|
|
Investigations
Investigations - Other, blood protein decreased
|
18.8%
15/80 • 18 months
|
|
Investigations
Investigations - Other, blood urea nitrogen increased
|
17.5%
14/80 • 18 months
|
|
Investigations
Investigations - Other, creatinine decreased
|
17.5%
14/80 • 18 months
|
|
Cardiac disorders
Cardiac disorders - Other, tachycardia
|
16.2%
13/80 • 18 months
|
|
Psychiatric disorders
Depression
|
16.2%
13/80 • 18 months
|
|
Investigations
Investigations - Other, blood chloride decreased
|
16.2%
13/80 • 18 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
15.0%
12/80 • 18 months
|
|
Investigations
Investigations - Other, blood urea nitrogen decreased
|
15.0%
12/80 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
15.0%
12/80 • 18 months
|
|
Nervous system disorders
Dysgeusia
|
13.8%
11/80 • 18 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
13.8%
11/80 • 18 months
|
|
Investigations
Investigations - Other, blood bicarbonate decreased
|
13.8%
11/80 • 18 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.8%
11/80 • 18 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, erythema
|
13.8%
11/80 • 18 months
|
|
Gastrointestinal disorders
abdominal pain
|
12.5%
10/80 • 18 months
|
|
Psychiatric disorders
Anxiety
|
12.5%
10/80 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
10/80 • 18 months
|
|
Gastrointestinal disorders
Mucositis
|
12.5%
10/80 • 18 months
|
|
Investigations
Investigations - Other, blood bicarbonate increased
|
11.2%
9/80 • 18 months
|
|
Investigations
Investigations - Other, blood chloride increased
|
11.2%
9/80 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.2%
9/80 • 18 months
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
8/80 • 18 months
|
|
General disorders
Chills
|
8.8%
7/80 • 18 months
|
|
Psychiatric disorders
confusion
|
8.8%
7/80 • 18 months
|
|
Investigations
Creatinine increased
|
8.8%
7/80 • 18 months
|
|
Injury, poisoning and procedural complications
Fall
|
8.8%
7/80 • 18 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
8.8%
7/80 • 18 months
|
|
Infections and infestations
Urinary Tract Infection
|
8.8%
7/80 • 18 months
|
|
Injury, poisoning and procedural complications
Bruising
|
7.5%
6/80 • 18 months
|
|
Vascular disorders
Hypertension
|
7.5%
6/80 • 18 months
|
|
Investigations
Lymphocyte count decreased
|
7.5%
6/80 • 18 months
|
|
General disorders
Malaise
|
7.5%
6/80 • 18 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.5%
6/80 • 18 months
|
|
Vascular disorders
Thromboembolic event
|
7.5%
6/80 • 18 months
|
|
Nervous system disorders
Tremor
|
7.5%
6/80 • 18 months
|
|
Investigations
Alanine aminotransferase increased
|
6.2%
5/80 • 18 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
5/80 • 18 months
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
5/80 • 18 months
|
|
Nervous system disorders
Headache
|
6.2%
5/80 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
6.2%
5/80 • 18 months
|
|
Infections and infestations
Infections and infestations - Other, oral infection
|
6.2%
5/80 • 18 months
|
|
Infections and infestations
Infections and infestations - Other, unspecified
|
6.2%
5/80 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
5/80 • 18 months
|
|
Renal and urinary disorders
Proteinuria
|
6.2%
5/80 • 18 months
|
|
Nervous system disorders
Somnolence
|
6.2%
5/80 • 18 months
|
|
Vascular disorders
flushing
|
5.0%
4/80 • 18 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.0%
4/80 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.0%
4/80 • 18 months
|
|
Psychiatric disorders
Psychiatric disorders - Other, change in mental status
|
5.0%
4/80 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, decreased breath sounds
|
5.0%
4/80 • 18 months
|
|
Infections and infestations
Sinusitis
|
5.0%
4/80 • 18 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, decreased turgor
|
5.0%
4/80 • 18 months
|
|
Nervous system disorders
Syncope
|
5.0%
4/80 • 18 months
|
Additional Information
John D Hainsworth, MD
Sarah Cannon Research Institute
Phone: 1-877-691-7274
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 but =180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites
- Publication restrictions are in place
Restriction type: OTHER