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Irinotecan, Carboplatin and Radiation Therapy Followed by Bevacizumab in Limited Stage Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00193375
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : November 13, 2012
Last Update Posted : August 10, 2016
Sponsor:
Collaborators:
Genentech, Inc.
Pharmacia and Upjohn
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Interventions Drug: Irinotecan
Drug: Carboplatin
Drug: Bevacizumab
Radiation: Radiation
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 60
Completed 41
Not Completed 19
Arm/Group Title Intervention
Hide Arm/Group Description 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).
Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 60 participants
65
(42 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
37
  61.7%
Male
23
  38.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants
60
1.Primary Outcome
Title Number of Grade 3/4 Toxicities Patients Experienced on Maintenance Bevacizumab Following Chemoradiation for Limited Stage - Small Cell Lung Cancer (LS-SCLC)
Hide Description Toxicity was evaluated in all patients who received at least 1 dose of therapy, and graded according to CTCAE v. 3.
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who received at least one dose of bevacizumab maintenance therapy were assessed for toxicities.
Arm/Group Title Intervention
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: Grade 3/4 Toxicity Events
Hemorrhage 2
Diarrhea 1
Fatigue 1
Hypertension 1
Nausea 1
Infection - Other (Pnemonia) 4
Pulmonary toxicities 4
Leukopenia 2
Neutropenia 1
Thrombocytopenia 1
2.Secondary Outcome
Title 2-Year Progression-free Survival (PFS)
Hide Description 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.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients were assessed for progression free survival.
Arm/Group Title Intervention
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: percentage of participants
22
3.Secondary Outcome
Title Overall Response Rate
Hide Description 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.
Time Frame 18 month
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
80
(68 to 89)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention
Hide Arm/Group Description 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).
All-Cause Mortality
Intervention
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Intervention
Affected / at Risk (%)
Total   35/60 (58.33%) 
Blood and lymphatic system disorders   
Hemorrhage, GI (Upper GI NOS)  1  2/60 (3.33%) 
Gastrointestinal disorders   
Dehydration  1  1/60 (1.67%) 
Fistula, GI – esophagus  1  1/60 (1.67%) 
Perforation, GI - Colon  1  1/60 (1.67%) 
Vomiting  1  6/60 (10.00%) 
General disorders   
Death not associated with CTCAE term (Disease Progression NOS)  1  3/60 (5.00%) 
Hepatobiliary disorders   
Liver dysfunction/failure (clinical)  1  1/60 (1.67%) 
Infections and infestations   
Infection - Other (Aspergillus pneumonia)  1  1/60 (1.67%) 
Infection – Other (influenza)  1  1/60 (1.67%) 
Infection with Grade 3/4 Neutrophils - Blood  1  1/60 (1.67%) 
Infection - Other (obstructive pneumonia)  1  1/60 (1.67%) 
Nervous system disorders   
Seizure  1  1/60 (1.67%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary/Upper Respiratory - Other (Acute respiratory failure)  1  1/60 (1.67%) 
Infection with unknown ANC - Lung (pnemonia)  1  3/60 (5.00%) 
Pneumonitis/pulmonary infiltrates  1  6/60 (10.00%) 
Pulmonary fibrosis (radiographic changes)  1  1/60 (1.67%) 
Vascular disorders   
Thrombosis/thrombus/embolism  1  4/60 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v. 3
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intervention
Affected / at Risk (%)
Total   60/60 (100.00%) 
Blood and lymphatic system disorders   
Neutrophils  1  53/60 (88.33%) 
Hemorrhage, Pulmonary/upper respiratory  1  6/60 (10.00%) 
Hemoglobin  1  57/60 (95.00%) 
Platelets  1  55/60 (91.67%) 
Leukocytes  1  56/60 (93.33%) 
Gastrointestinal disorders   
Anorexia  1  22/60 (36.67%) 
Constipation  1  24/60 (40.00%) 
Dehydration  1  3/60 (5.00%) 
Diarrhea  1  28/60 (46.67%) 
Dyspepsia  1  3/60 (5.00%) 
Dysphagia  1  5/60 (8.33%) 
Esophagitis  1  9/60 (15.00%) 
Nausea  1  44/60 (73.33%) 
Vomiting  1  21/60 (35.00%) 
General disorders   
Pain - joint  1  3/60 (5.00%) 
Pain - back  1  3/60 (5.00%) 
Edema  1  8/60 (13.33%) 
Fatigue  1  51/60 (85.00%) 
Insomnia  1  3/60 (5.00%) 
Fatigue  1  14/60 (23.33%) 
Infections and infestations   
Infection  1  3/60 (5.00%) 
Metabolism and nutrition disorders   
Hyperglycemia  1  5/60 (8.33%) 
Hypokalemia  1  3/60 (5.00%) 
Musculoskeletal and connective tissue disorders   
Pain - muscle  1  3/60 (5.00%) 
Nervous system disorders   
Dizziness  1  3/60 (5.00%) 
Psychiatric disorders   
Mood Alteration - Anxiety  1  4/60 (6.67%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  4/60 (6.67%) 
Pulmonary Symptoms  1  24/60 (40.00%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  4/60 (6.67%) 
Rash  1  16/60 (26.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v. 3
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John Hainsworth, MD
Organization: Sarah Cannon Research Institute
Phone: 1-877-691-7274
EMail: ASKSARAH@scresearch.net
Layout table for additonal information
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00193375    
Other Study ID Numbers: SCRI LUN 72
First Submitted: September 12, 2005
First Posted: September 19, 2005
Results First Submitted: October 5, 2012
Results First Posted: November 13, 2012
Last Update Posted: August 10, 2016