Trial Outcomes & Findings for Irinotecan, Carboplatin and Radiation Therapy Followed by Bevacizumab in Limited Stage Small Cell Lung Cancer (NCT NCT00193375)
NCT ID: NCT00193375
Last Updated: 2016-08-10
Results Overview
Toxicity was evaluated in all patients who received at least 1 dose of therapy, and graded according to CTCAE v. 3.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
18 months
Results posted on
2016-08-10
Participant Flow
Participant milestones
| Measure |
Intervention
Patients received carboplatin \[area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4\], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
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|---|---|
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Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Irinotecan, Carboplatin and Radiation Therapy Followed by Bevacizumab in Limited Stage Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Intervention
n=60 Participants
Patients received carboplatin \[area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4\], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
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|---|---|
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Age, Continuous
|
65 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
|
Region of Enrollment
United States
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60 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Patients who received at least one dose of bevacizumab maintenance therapy were assessed for toxicities.
Toxicity was evaluated in all patients who received at least 1 dose of therapy, and graded according to CTCAE v. 3.
Outcome measures
| Measure |
Intervention
n=41 Participants
Patients received carboplatin \[area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4\], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
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|---|---|
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Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC)
Hemorrhage
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2 Grade 3/4 Toxicity Events
|
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Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC)
Diarrhea
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1 Grade 3/4 Toxicity Events
|
|
Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC)
Fatigue
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1 Grade 3/4 Toxicity Events
|
|
Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC)
Hypertension
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1 Grade 3/4 Toxicity Events
|
|
Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC)
Nausea
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1 Grade 3/4 Toxicity Events
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Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC)
Infection - Other (Pnemonia)
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4 Grade 3/4 Toxicity Events
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|
Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC)
Pulmonary toxicities
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4 Grade 3/4 Toxicity Events
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|
Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC)
Leukopenia
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2 Grade 3/4 Toxicity Events
|
|
Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC)
Neutropenia
|
1 Grade 3/4 Toxicity Events
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Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC)
Thrombocytopenia
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1 Grade 3/4 Toxicity Events
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SECONDARY outcome
Timeframe: 24 monthsPopulation: All patients were assessed for progression free survival.
Progression-free survival (PFS) was defined as the date of study entry until the date of tumor progression or death. 2-Year PFS is the percentage of patients alive and without progressive disease (PD) 2 years from the date of study entry.
Outcome measures
| Measure |
Intervention
n=60 Participants
Patients received carboplatin \[area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4\], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
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|---|---|
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2-Year Progression-free Survival (PFS)
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22 percentage of participants
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SECONDARY outcome
Timeframe: 18 monthPopulation: All patients were evaluated for response by RECIST v. 1 criteria. All patients with major responses had confirmation of response on repeat scans by the same technique(s) 4 weeks (or longer) later.
Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.
Outcome measures
| Measure |
Intervention
n=60 Participants
Patients received carboplatin \[area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4\], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
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|---|---|
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Overall Response Rate
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80 percentage of participants
Interval 68.0 to 89.0
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Adverse Events
Intervention
Serious events: 35 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention
n=60 participants at risk
Patients received carboplatin \[area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4\], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
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|---|---|
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Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other (Acute respiratory failure)
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1.7%
1/60
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Blood and lymphatic system disorders
Hemorrhage, GI (Upper GI NOS)
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3.3%
2/60
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Infections and infestations
Infection - Other (Aspergillus pneumonia)
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1.7%
1/60
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Gastrointestinal disorders
Dehydration
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1.7%
1/60
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General disorders
Death not associated with CTCAE term (Disease Progression NOS)
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5.0%
3/60
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Gastrointestinal disorders
Fistula, GI - esophagus
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1.7%
1/60
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Hepatobiliary disorders
Liver dysfunction/failure (clinical)
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1.7%
1/60
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Infections and infestations
Infection - Other (influenza)
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1.7%
1/60
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|
Infections and infestations
Infection with Grade 3/4 Neutrophils - Blood
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1.7%
1/60
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Infections and infestations
Infection - Other (obstructive pneumonia)
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1.7%
1/60
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|
Gastrointestinal disorders
Perforation, GI - Colon
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1.7%
1/60
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Respiratory, thoracic and mediastinal disorders
Infection with unknown ANC - Lung (pnemonia)
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5.0%
3/60
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Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
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10.0%
6/60
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Vascular disorders
Thrombosis/thrombus/embolism
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6.7%
4/60
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Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis (radiographic changes)
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1.7%
1/60
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Nervous system disorders
Seizure
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1.7%
1/60
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Gastrointestinal disorders
Vomiting
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10.0%
6/60
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Other adverse events
| Measure |
Intervention
n=60 participants at risk
Patients received carboplatin \[area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4\], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
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|---|---|
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Skin and subcutaneous tissue disorders
Alopecia
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6.7%
4/60
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Blood and lymphatic system disorders
Neutrophils
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88.3%
53/60
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Gastrointestinal disorders
Anorexia
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36.7%
22/60
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Psychiatric disorders
Mood Alteration - Anxiety
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6.7%
4/60
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General disorders
Pain - joint
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5.0%
3/60
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General disorders
Pain - back
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5.0%
3/60
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Gastrointestinal disorders
Constipation
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40.0%
24/60
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Respiratory, thoracic and mediastinal disorders
Cough
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6.7%
4/60
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Gastrointestinal disorders
Dehydration
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5.0%
3/60
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Gastrointestinal disorders
Diarrhea
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46.7%
28/60
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Nervous system disorders
Dizziness
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5.0%
3/60
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Gastrointestinal disorders
Dyspepsia
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5.0%
3/60
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Gastrointestinal disorders
Dysphagia
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8.3%
5/60
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General disorders
Edema
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13.3%
8/60
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|
Gastrointestinal disorders
Esophagitis
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15.0%
9/60
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General disorders
Fatigue
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23.3%
14/60
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Blood and lymphatic system disorders
Hemorrhage, Pulmonary/upper respiratory
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10.0%
6/60
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Blood and lymphatic system disorders
Hemoglobin
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95.0%
57/60
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|
Metabolism and nutrition disorders
Hyperglycemia
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8.3%
5/60
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|
Metabolism and nutrition disorders
Hypokalemia
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5.0%
3/60
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|
Infections and infestations
Infection
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5.0%
3/60
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|
General disorders
Insomnia
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5.0%
3/60
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|
Musculoskeletal and connective tissue disorders
Pain - muscle
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5.0%
3/60
|
|
Gastrointestinal disorders
Nausea
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73.3%
44/60
|
|
Blood and lymphatic system disorders
Platelets
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91.7%
55/60
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|
Respiratory, thoracic and mediastinal disorders
Pulmonary Symptoms
|
40.0%
24/60
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Skin and subcutaneous tissue disorders
Rash
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26.7%
16/60
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|
Gastrointestinal disorders
Vomiting
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35.0%
21/60
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|
Blood and lymphatic system disorders
Leukocytes
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93.3%
56/60
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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