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Cisplatin, Etoposide, and Bevacizumab in Treating Patients With Previously Untreated Extensive Stage Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00079040
Recruitment Status : Completed
First Posted : March 9, 2004
Results First Posted : February 2, 2010
Last Update Posted : May 14, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Extensive Stage Small Cell Lung Cancer
Interventions Drug: cisplatin
Drug: etoposide
Biological: bevacizumab
Other: laboratory biomarker analysis
Enrollment 65
Recruitment Details Participants were recruited from ECOG member institutions between June 8, 2004 and August 18, 2006.
Pre-assignment Details  
Arm/Group Title Cisplatin, Etoposide, Bevacizumab
Hide Arm/Group Description Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
Period Title: Overall Study
Started 65
Completed 63
Not Completed 2
Reason Not Completed
Withdrew before treatment             1
Ineligible             1
Arm/Group Title Cisplatin, Etoposide, Bevacizumab
Hide Arm/Group Description Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
Overall Number of Baseline Participants 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 63 participants
65
(45 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
Female
36
  57.1%
Male
27
  42.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 63 participants
63
1.Primary Outcome
Title Percentage of Participants Alive and Progression-free (PF) at 6 Months
Hide Description Progression-free survival was defined to be the interval in months from the date of registration to the date of documented disease progression or to death without progression. Patients alive without progression at 6 months were included in the numerator when calculating the progression-free rate.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol, the analysis included all eligible, treated patients (n=63). The safety analysis included all treated patients, regardless of eligibility (n=64).
Arm/Group Title Cisplatin, Etoposide, Bevacizumab
Hide Arm/Group Description:
Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
Overall Number of Participants Analyzed 63
Mean (95% Confidence Interval)
Unit of Measure: Percentage of Participants
30.2
(19.3 to 43.1)
2.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the time from registration to death or date last known alive. Patients alive at last follow-up are censored.
Time Frame Assessed every 3 months for 2 years, then every 6 months for 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol, the analysis included all eligible, treated patients
Arm/Group Title Cisplatin, Etoposide, Bevacizumab
Hide Arm/Group Description:
Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
Overall Number of Participants Analyzed 63
Median (95% Confidence Interval)
Unit of Measure: months
10.9
(7.9 to 12.2)
3.Secondary Outcome
Title Best Objective Response
Hide Description Number of patients with complete or partial response by RECIST criteria.
Time Frame Assessed every 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol, the analysis included all eligible, treated patients.
Arm/Group Title Cisplatin, Etoposide, Bevacizumab
Hide Arm/Group Description:
Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
Overall Number of Participants Analyzed 63
Measure Type: Number
Unit of Measure: Patients Responding
40
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cisplatin, Etoposide, Bevacizumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage
Estimated Value 63.5
Confidence Interval (2-Sided) 90%
52.4 to 73.6
Estimation Comments [Not Specified]
Time Frame Adverse events were assessed at each treatment visit (approximately every 3 weeks) and through 30 days following the end of treatment
Adverse Event Reporting Description Assessment was done routinely for the safety population, which consisted of all 64 treated patients.
 
Arm/Group Title Cisplatin, Etoposide, Bevacizumab
Hide Arm/Group Description Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
All-Cause Mortality
Cisplatin, Etoposide, Bevacizumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cisplatin, Etoposide, Bevacizumab
Affected / at Risk (%)
Total   49/64 (76.56%) 
Blood and lymphatic system disorders   
Low Hemoglobin  1  3/64 (4.69%) 
Low Leukocytes  1  19/64 (29.69%) 
Lymphopenia  1  1/64 (1.56%) 
Low Neutrophils  1  37/64 (57.81%) 
Low Platelets  1  9/64 (14.06%) 
Cardiac disorders   
Sinus Bradycardia  1  1/64 (1.56%) 
Cardiac ischemia  1  1/64 (1.56%) 
Hypertension  1  5/64 (7.81%) 
Hypotension  1  1/64 (1.56%) 
Left ventricular diastolic dysfunction  1  1/64 (1.56%) 
Cardiac - other  1  1/64 (1.56%) 
Gastrointestinal disorders   
Anorexia  1  1/64 (1.56%) 
Dehydration  1  3/64 (4.69%) 
Diarrhea w/o prior colostomy  1  1/64 (1.56%) 
Muco/stomatitis  1  1/64 (1.56%) 
Nausea  1  2/64 (3.13%) 
Vomiting  1  2/64 (3.13%) 
Abdomen, hemorrhage  1  1/64 (1.56%) 
General disorders   
Fatigue  1  8/64 (12.50%) 
Death - multiorgan failure  1  1/64 (1.56%) 
Nonneuropathic generalized weakness  1  1/64 (1.56%) 
Immune system disorders   
Allergic Reaction  1  1/64 (1.56%) 
Infections and infestations   
Febrile Neutropenia  1  3/64 (4.69%) 
Infection w/ gr 3-4 neutrophils, lung  1  1/64 (1.56%) 
Infection w/ gr 0-2 neutrophils, lung  1  1/64 (1.56%) 
Infection w/ gr 3-4 neutrophils, blood  1  2/64 (3.13%) 
Metabolism and nutrition disorders   
Hypocalcemia  1  2/64 (3.13%) 
Hypokalemia  1  1/64 (1.56%) 
Hyponatremia  1  7/64 (10.94%) 
Musculoskeletal and connective tissue disorders   
Extremity, lower (gait/walking)  1  1/64 (1.56%) 
Back, pain  1  1/64 (1.56%) 
Bone, pain  1  1/64 (1.56%) 
Joint, pain  1  3/64 (4.69%) 
Muscle, pain  1  1/64 (1.56%) 
Nervous system disorders   
Ataxia  1  1/64 (1.56%) 
Dizziness  1  1/64 (1.56%) 
Headache  1  1/64 (1.56%) 
Pain, other  1  1/64 (1.56%) 
Respiratory, thoracic and mediastinal disorders   
Bronchopulmonary, hemorrhage  1  1/64 (1.56%) 
Dyspnea  1  1/64 (1.56%) 
Pulmonary/upper respiratory, other  1  1/64 (1.56%) 
Vascular disorders   
Thrombosis/thrombus/embolism  1  1/64 (1.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cisplatin, Etoposide, Bevacizumab
Affected / at Risk (%)
Total   63/64 (98.44%) 
Blood and lymphatic system disorders   
Hemoglobin  1  4/64 (6.25%) 
Leukocytes  1  40/64 (62.50%) 
Neutrophils  1  33/64 (51.56%) 
Platelets  1  28/64 (43.75%) 
Cardiac disorders   
Hypertension  1  9/64 (14.06%) 
Hypotension  1  7/64 (10.94%) 
Eye disorders   
Vision - blurred  1  5/64 (7.81%) 
Gastrointestinal disorders   
Anorexia  1  28/64 (43.75%) 
Constipation  1  30/64 (46.88%) 
Diarrhea w/o prior colostomy  1  17/64 (26.56%) 
Dysphagia  1  4/64 (6.25%) 
Dyspepsia  1  10/64 (15.63%) 
Muco/stomatitis by exam, oral cavity  1  14/64 (21.88%) 
Muco/stomatitis (symptom), oral cavity  1  11/64 (17.19%) 
Nausea  1  43/64 (67.19%) 
Taste disturbance  1  9/64 (14.06%) 
Vomiting  1  18/64 (28.13%) 
General disorders   
Insomnia  1  6/64 (9.38%) 
Rigors/chills  1  7/64 (10.94%) 
Weight loss  1  8/64 (12.50%) 
Infections and infestations   
Fever w/o neutropenia  1  7/64 (10.94%) 
Metabolism and nutrition disorders   
Alkaline phosphatase  1  12/64 (18.75%) 
AST, SGOT  1  13/64 (20.31%) 
Hypercalcemia  1  7/64 (10.94%) 
Hypocalcemia  1  9/64 (14.06%) 
Creatinine  1  19/64 (29.69%) 
Hypomagnesemia  1  21/64 (32.81%) 
Hyperkalemia  1  10/64 (15.63%) 
Hypokalemia  1  11/64 (17.19%) 
Proteinuria  1  8/64 (12.50%) 
Hyponatremia  1  26/64 (40.63%) 
Musculoskeletal and connective tissue disorders   
Back, pain  1  6/64 (9.38%) 
Muscle, pain  1  11/64 (17.19%) 
Nervous system disorders   
Dizziness  1  6/64 (9.38%) 
Neuropathy, motor  1  5/64 (7.81%) 
Neuropathy, sensory  1  17/64 (26.56%) 
Headache  1  10/64 (15.63%) 
Respiratory, thoracic and mediastinal disorders   
Nose, hemorrhage  1  6/64 (9.38%) 
Cough  1  9/64 (14.06%) 
Dyspnea  1  12/64 (18.75%) 
Voice changes/dysarthria  1  7/64 (10.94%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  47/64 (73.44%) 
Injection site reaction  1  4/64 (6.25%) 
Pruritis/itching  1  4/64 (6.25%) 
Rash/desquamation  1  6/64 (9.38%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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.
Results Point of Contact
Name/Title: Study Statistician
Organization: ECOG Statistical Office
Phone: 617-632-3012
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00079040     History of Changes
Other Study ID Numbers: NCI-2012-02944
NCI-2012-02944 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ECOG-E3501
E3501 ( Other Identifier: Eastern Cooperative Oncology Group )
E3501 ( Other Identifier: CTEP )
U10CA021115 ( U.S. NIH Grant/Contract )
First Submitted: March 8, 2004
First Posted: March 9, 2004
Results First Submitted: November 19, 2009
Results First Posted: February 2, 2010
Last Update Posted: May 14, 2014