Trial Outcomes & Findings for Irinotecan, Carboplatin, and Sunitinib in First Line Extensive-Stage Small Cell Lung Cancer (NCT NCT00695292)
NCT ID: NCT00695292
Last Updated: 2021-11-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
18 months
Results posted on
2021-11-22
Participant Flow
Participant milestones
| Measure |
Irinotecan, Carboplatin, Sunitinib
Patients receive irinotecan 60mg/m2 IV on days 1, 8, and 15 and carboplatin AUC=4 on day 1 of each 28-day cycle. After completion of 6 cycles, patients receive only sunitinib 25 mg daily by mouth.
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Irinotecan, Carboplatin, and Sunitinib in First Line Extensive-Stage Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Irinotecan, Carboplatin, Sunitinib
n=37 Participants
Patients receive irinotecan 60mg/m2 IV on days 1, 8, and 15 and carboplatin AUC=4 on day 1 of each 28-day cycle. After completion of 6 cycles, patients receive only sunitinib 25 mg daily by mouth.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: The original study design administered sunitinib concurrently with irinotecan/carboplatin. After the first three patients enrolled experienced severe myelosuppression, the treatment plan was modified to delay sunitinib until after completion of combination therapy. Only patients treated under the revised plan are included in the results analysis.
Outcome measures
| Measure |
Irinotecan, Carboplatin, Sunitinib
n=34 Participants
Patients receive irinotecan 60mg/m2 IV on days 1, 8, and 15 and carboplatin AUC=4 on day 1 of each 28-day cycle. After completion of 6 cycles, patients receive only sunitinib 25 mg daily by mouth.
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|---|---|
|
One-year Survival, The Percentage of Patients Who Are Alive One Year After Completing Protocol Treatment
|
54 percentage of participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: The original study design administered sunitinib concurrently with irinotecan/carboplatin. After the first three patients enrolled experienced severe myelosuppression, the treatment plan was modified to delay sunitinib until after completion of combination therapy. Only patients treated under the revised plan are included in the results analysis.
Objective benefit is defined as substantial (30% or greater) shrinkage in tumor volume per RECIST 1.0.
Outcome measures
| Measure |
Irinotecan, Carboplatin, Sunitinib
n=34 Participants
Patients receive irinotecan 60mg/m2 IV on days 1, 8, and 15 and carboplatin AUC=4 on day 1 of each 28-day cycle. After completion of 6 cycles, patients receive only sunitinib 25 mg daily by mouth.
|
|---|---|
|
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
|
59 percentage of participants
Interval 41.0 to 75.0
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: The original study design administered sunitinib concurrently with irinotecan/carboplatin. After the first three patients enrolled experienced severe myelosuppression, the treatment plan was modified to delay sunitinib until after completion of combination therapy. Only patients treated under the revised plan are included in the results analysis.
Time To Progression (TTP) was defined as the interval between the start date of treatment and the date of occurrence of progressive disease
Outcome measures
| Measure |
Irinotecan, Carboplatin, Sunitinib
n=34 Participants
Patients receive irinotecan 60mg/m2 IV on days 1, 8, and 15 and carboplatin AUC=4 on day 1 of each 28-day cycle. After completion of 6 cycles, patients receive only sunitinib 25 mg daily by mouth.
|
|---|---|
|
Time to Progression
|
7.6 months
Interval 5.7 to 9.0
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: The original study design administered sunitinib concurrently with irinotecan/carboplatin. After the first three patients enrolled experienced severe myelosuppression, the treatment plan was modified to delay sunitinib until after completion of combination therapy. Only patients treated under the revised plan are included in the results analysis.
Overall survival was defined as the interval between the date of study entry until the date of death.
Outcome measures
| Measure |
Irinotecan, Carboplatin, Sunitinib
n=34 Participants
Patients receive irinotecan 60mg/m2 IV on days 1, 8, and 15 and carboplatin AUC=4 on day 1 of each 28-day cycle. After completion of 6 cycles, patients receive only sunitinib 25 mg daily by mouth.
|
|---|---|
|
Median Overall Survival
|
NA months
The median overall survival (OS) has not been reached due to insufficient observed events
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Toxicity was evaluated in all patients who received at least 1 dose of therapy. The original study design administered sunitinib concurrently with irinotecan/carboplatin. After the first three patients enrolled experienced severe myelosuppression, the treatment plan was modified to delay sunitinib until after completion of combination therapy. Only patients treated under the revised plan are included in the results analysis.
The toxicity assessments were made according to the common terminology criteria for adverse events (CTCAE version 3.0) of the National Cancer Institute. Number of participants with Grade 1 to 5 adverse events are reported here.
Outcome measures
| Measure |
Irinotecan, Carboplatin, Sunitinib
n=34 Participants
Patients receive irinotecan 60mg/m2 IV on days 1, 8, and 15 and carboplatin AUC=4 on day 1 of each 28-day cycle. After completion of 6 cycles, patients receive only sunitinib 25 mg daily by mouth.
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|---|---|
|
Number of Participants Experiencing Treatment Related Toxicity
|
32 Participants
|
Adverse Events
Intervention
Serious events: 18 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention
n=37 participants at risk
Patients in the study will receive the following for the duration of the study: irinotecan 60 mg/m2 intravenously on Days 1, 8, and 15 and carboplatin AUC=4 on Day 1. The study will consist of 28-day cycles, to a maximum of 6 cycles of therapy with irinotecan and carboplatin. After treatment with irinotecan and carboplatin, sunitinib will be given alone as maintenance therapy in all patients who have achieved study entry hematologic criteria and who do not have progressive disease or severe toxicity. During sunitinib maintenance therapy, patients will receive sunitinib at 25 mg orally daily. Sunitinib maintenance therapy will continue until progressive disease or irreversible toxicity occurs.
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|---|---|
|
General disorders
Death
|
2.7%
1/37 • Number of events 1
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.7%
1/37 • Number of events 1
|
|
Blood and lymphatic system disorders
Platelets
|
2.7%
1/37 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.4%
2/37 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
ARDS
|
5.4%
2/37 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease Progression
|
10.8%
4/37 • Number of events 4
|
|
Infections and infestations
Infection - Sepsis
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
Diverticulitis
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
2.7%
1/37 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
1/37 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
2.7%
1/37 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.7%
1/37 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
2.7%
1/37 • Number of events 1
|
|
Cardiac disorders
Pain - Chest
|
2.7%
1/37 • Number of events 1
|
|
General disorders
Intractable Pain
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
Infection - Pneumonia
|
2.7%
1/37 • Number of events 1
|
Other adverse events
| Measure |
Intervention
n=37 participants at risk
Patients in the study will receive the following for the duration of the study: irinotecan 60 mg/m2 intravenously on Days 1, 8, and 15 and carboplatin AUC=4 on Day 1. The study will consist of 28-day cycles, to a maximum of 6 cycles of therapy with irinotecan and carboplatin. After treatment with irinotecan and carboplatin, sunitinib will be given alone as maintenance therapy in all patients who have achieved study entry hematologic criteria and who do not have progressive disease or severe toxicity. During sunitinib maintenance therapy, patients will receive sunitinib at 25 mg orally daily. Sunitinib maintenance therapy will continue until progressive disease or irreversible toxicity occurs.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.8%
4/37 • Number of events 15
|
|
Gastrointestinal disorders
Anorexia
|
29.7%
11/37 • Number of events 21
|
|
Metabolism and nutrition disorders
AST
|
5.4%
2/37 • Number of events 3
|
|
Nervous system disorders
Ataxia
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
35.1%
13/37 • Number of events 40
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.9%
7/37 • Number of events 12
|
|
Metabolism and nutrition disorders
Creatinine
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
Dehydration
|
29.7%
11/37 • Number of events 11
|
|
Gastrointestinal disorders
Diarrhea
|
54.1%
20/37 • Number of events 64
|
|
Nervous system disorders
Dizziness
|
18.9%
7/37 • Number of events 16
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
37.8%
14/37 • Number of events 58
|
|
Blood and lymphatic system disorders
Edema: Limb
|
18.9%
7/37 • Number of events 20
|
|
Gastrointestinal disorders
Esophagitis
|
10.8%
4/37 • Number of events 4
|
|
General disorders
Fatigue
|
81.1%
30/37 • Number of events 117
|
|
Infections and infestations
Febrile Neutropenia
|
5.4%
2/37 • Number of events 2
|
|
General disorders
Fever
|
16.2%
6/37 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Gait/Walking
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
Heartburn
|
21.6%
8/37 • Number of events 22
|
|
Blood and lymphatic system disorders
Hemoglobin
|
91.9%
34/37 • Number of events 117
|
|
Blood and lymphatic system disorders
Hemorrhage - Nose
|
5.4%
2/37 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemorrhage, Pulmonary/Upper Respiratory
|
5.4%
2/37 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.8%
4/37 • Number of events 12
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.4%
2/37 • Number of events 2
|
|
Cardiac disorders
Hypertension
|
5.4%
2/37 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
13.5%
5/37 • Number of events 9
|
|
Metabolism and nutrition disorders
Hypokalemia
|
21.6%
8/37 • Number of events 12
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.4%
2/37 • Number of events 10
|
|
Metabolism and nutrition disorders
Hyponatremia
|
24.3%
9/37 • Number of events 10
|
|
Cardiac disorders
Hypotension
|
16.2%
6/37 • Number of events 15
|
|
Infections and infestations
Infection - Other
|
5.4%
2/37 • Number of events 2
|
|
Infections and infestations
Infection - Pneumonia
|
13.5%
5/37 • Number of events 6
|
|
General disorders
Insomnia
|
21.6%
8/37 • Number of events 12
|
|
Blood and lymphatic system disorders
Leukocytes
|
83.8%
31/37 • Number of events 93
|
|
Psychiatric disorders
Mood Alteration - Anxiety
|
13.5%
5/37 • Number of events 16
|
|
Gastrointestinal disorders
Mucositis/Stomatitis
|
21.6%
8/37 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness (Extremity-Lower)
|
8.1%
3/37 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness (NOS)
|
5.4%
2/37 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
73.0%
27/37 • Number of events 72
|
|
Nervous system disorders
Neuropathy: Motor
|
5.4%
2/37 • Number of events 3
|
|
Nervous system disorders
Neuropathy: Sensory
|
10.8%
4/37 • Number of events 9
|
|
Blood and lymphatic system disorders
Neutrophils
|
75.7%
28/37 • Number of events 64
|
|
General disorders
Pain - Muscle
|
10.8%
4/37 • Number of events 5
|
|
General disorders
Pain - Other
|
10.8%
4/37 • Number of events 10
|
|
General disorders
Pain - Abdomen
|
21.6%
8/37 • Number of events 19
|
|
General disorders
Pain - Back
|
18.9%
7/37 • Number of events 17
|
|
General disorders
Pain - Bone
|
10.8%
4/37 • Number of events 7
|
|
General disorders
Pain - Chest
|
21.6%
8/37 • Number of events 12
|
|
General disorders
Pain - Dental/Teeth/Periodontal
|
5.4%
2/37 • Number of events 3
|
|
General disorders
Pain - Head
|
18.9%
7/37 • Number of events 12
|
|
General disorders
Pain - Joint
|
29.7%
11/37 • Number of events 28
|
|
General disorders
Pain - Limb
|
16.2%
6/37 • Number of events 12
|
|
Blood and lymphatic system disorders
Platelets
|
62.2%
23/37 • Number of events 53
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.1%
3/37 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary, Other (COPD)
|
8.1%
3/37 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
8.1%
3/37 • Number of events 8
|
|
Renal and urinary disorders
Renal Failure
|
5.4%
2/37 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
13.5%
5/37 • Number of events 5
|
|
General disorders
Rigors/Chills
|
5.4%
2/37 • Number of events 2
|
|
Cardiac disorders
Superventricular Arrhythmia (Atrial Fibrillation)
|
5.4%
2/37 • Number of events 2
|
|
Cardiac disorders
Supraventricular Arrhythmia (Tachycardia)
|
8.1%
3/37 • Number of events 4
|
|
General disorders
Sweating
|
10.8%
4/37 • Number of events 5
|
|
Gastrointestinal disorders
Taste Alteration
|
13.5%
5/37 • Number of events 9
|
|
Nervous system disorders
Tremor
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
37.8%
14/37 • Number of events 40
|
|
Metabolism and nutrition disorders
Weight Gain
|
5.4%
2/37 • Number of events 3
|
|
Metabolism and nutrition disorders
Weight Loss
|
13.5%
5/37 • Number of events 6
|
Additional Information
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 days 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