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Trial record 66 of 78 for:    vismodegib

A Randomized Phase II Study of Cisplatin and Etoposide in Combination With Either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMC-A12 for Patients With Extensive Stage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00887159
Recruitment Status : Completed
First Posted : April 23, 2009
Results First Posted : July 29, 2015
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Extensive Stage Small Cell Lung Carcinoma
Recurrent Small Cell Lung Carcinoma
Interventions Drug: Cisplatin
Biological: Cixutumumab
Drug: Etoposide
Other: Laboratory Biomarker Analysis
Drug: Vismodegib
Enrollment 168
Recruitment Details Participants were recruited from ECOG member institutions between July, 16, 2009 and August 12, 2011.
Pre-assignment Details  
Arm/Group Title Arm A (CE) Arm B (CE+GDC-0449) Arm C (CE+IMC-A12)
Hide Arm/Group Description

Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

cisplatin: Given IV

etoposide: Given IV

Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.

vismodegib: Given PO

cisplatin: Given IV

etoposide: Given IV

Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

cisplatin: Given IV

etoposide: Given IV

Period Title: Overall Study
Started 56 56 56
Patients Who Started Assigned Treatment 53 53 52
Eligible and Treated Patients 48 52 52
Eligible/Treated Pts With CTCs Results 40 42 38
Completed 27 0 [1] 0 [1]
Not Completed 29 56 56
Reason Not Completed
Disease progression             6             39             33
Adverse Event             3             4             17
Death             2             2             0
Withdrawal by Subject             4             4             2
Alternative therapy             2             0             0
Physician Decision             1             1             0
Sympomatic deterioration             1             0             0
Treatment delayed             1             1             0
Pt had PD but was SD when re-measured             0             1             0
Received more tx instead of observation             1             0             0
Ineligible             5             1             0
Never started assigned therapy             3             3             4
[1]
Treatment continued until disease progression or unacceptable toxicity.
Arm/Group Title Arm A (CE) Arm B (CE+GDC-0449) Arm C (CE+IMC-A12) Total
Hide Arm/Group Description

Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

cisplatin: Given IV

etoposide: Given IV

Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.

vismodegib: Given PO

cisplatin: Given IV

etoposide: Given IV

Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

cisplatin: Given IV

etoposide: Given IV

Total of all reporting groups
Overall Number of Baseline Participants 48 52 52 152
Hide Baseline Analysis Population Description
Eligible and treated patients.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 48 participants 52 participants 52 participants 152 participants
61
(38 to 77)
64
(52 to 87)
64
(45 to 83)
63
(38 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 52 participants 52 participants 152 participants
Female
25
  52.1%
26
  50.0%
25
  48.1%
76
  50.0%
Male
23
  47.9%
26
  50.0%
27
  51.9%
76
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 48 participants 52 participants 52 participants 152 participants
48 52 52 152
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description Progression-free survival (PFS) is defined as the time from randomization to death or disease progression, whichever occurred first. Patients who were alive at the time of analysis are censored at the date at which they are last known to be alive and progression-free.
Time Frame Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients.
Arm/Group Title Arm A (CE) Arm B (CE+GDC-0449) Arm C (CE+IMC-A12)
Hide Arm/Group Description:
Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 48 52 52
Median (95% Confidence Interval)
Unit of Measure: months
4.4
(3.6 to 5.5)
4.4
(4.1 to 5.4)
4.6
(4.4 to 5.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (CE), Arm B (CE+GDC-0449)
Comments There are 2 primary comparisons and each involves comparing the experimental arms (B, C) to the control arm (A). Accrual goal was 54 patients per arm. With a 1-sided 0.1 level logrank test for each test, we have 90% power to detect a 42% reduction in the PFS hazard rate of 0.139 to 0.082 (corresponding to an improvement in median PFS of 5 months to 8.5 months) with 18-month accrual and 12-month follow-up; assuming exponential survival. For each test, 94 events are needed to achieve this power.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments P-value is one-sided.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.65 to 1.47
Estimation Comments The hazard ratio was derived comparing Arm B to Arm A.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm A (CE), Arm C (CE+IMC-A12)
Comments There are 2 primary comparisons and each involves comparing the experimental arms (B, C) to the control arm (A). Accrual goal was 54 patients per arm. With a 1-sided 0.1 level logrank test for each test, we have 90% power to detect a 42% reduction in the PFS hazard rate of 0.139 to 0.082 (corresponding to an improvement in median PFS of 5 months to 8.5 months) with 18-month accrual and 12-month follow-up; assuming exponential survival. For each test, 94 events are needed to achieve this power.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments P-value is one-sided.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.66 to 1.48
Estimation Comments Hazard ratio was derived comparing Arm C to Arm A.
2.Secondary Outcome
Title Response Rate
Hide Description Response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all eligible and treated patients. Responses are evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and persistence of one or more non-target lesion(s).
Time Frame Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients.
Arm/Group Title Arm A (CE) Arm B (CE+GDC-0449) Arm C (CE+IMC-A12)
Hide Arm/Group Description:
Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 48 52 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of patients
0.48
(0.33 to 0.63)
0.56
(0.41 to 0.70)
0.50
(0.36 to 0.64)
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival is defined as the time from randomization to death or date of last known alive.
Time Frame Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients.
Arm/Group Title Arm A (CE) Arm B (CE+GDC-0449) Arm C (CE+IMC-A12)
Hide Arm/Group Description:
Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 48 52 52
Median (95% Confidence Interval)
Unit of Measure: months
8.8
(7.8 to 11.2)
9.8
(8.7 to 12.4)
10.1
(8.8 to 14.0)
4.Secondary Outcome
Title PFS
Hide Description Progression-free survival (PFS) is defined as the time from randomization to death or disease progression, whichever occurred first. Patients who were alive at the time of analysis are censored at the date at which they are last known to be alive and progression-free. This analysis is to evaluate the association between PFS and circulating tumor cells (CTCs).
Time Frame Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients who had baseline CTC results available for analysis.
Arm/Group Title High CTC Count Low CTC Count
Hide Arm/Group Description:
High CTC count is defined as greater than 100 CTCs per 7.5 ml at baseline.
Low CTC count is defined as <= 100 CTCs per 7.5 ml at baseline.
Overall Number of Participants Analyzed 39 81
Median (95% Confidence Interval)
Unit of Measure: months
4.1
(3.3 to 5.4)
4.5
(4.4 to 5.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High CTC Count, Low CTC Count
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.69
Confidence Interval (2-Sided) 95%
1.13 to 2.52
Estimation Comments Hazard ratio was derived comparing the high CTCs group to the low CTCs group.
Time Frame Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A (CE) Arm B (CE+GDC-0449) Arm C (CE+IMC-A12)
Hide Arm/Group Description Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity. Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Arm A (CE) Arm B (CE+GDC-0449) Arm C (CE+IMC-A12)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm A (CE) Arm B (CE+GDC-0449) Arm C (CE+IMC-A12)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   45/53 (84.91%)   44/53 (83.02%)   47/52 (90.38%) 
Blood and lymphatic system disorders       
Anemia  1  13/53 (24.53%)  6/53 (11.32%)  7/52 (13.46%) 
Febrile neutropenia  1  8/53 (15.09%)  6/53 (11.32%)  2/52 (3.85%) 
Cardiac disorders       
Myocardial infarction  1  1/53 (1.89%)  0/53 (0.00%)  0/52 (0.00%) 
Ear and labyrinth disorders       
Tinnitus  1  0/53 (0.00%)  1/53 (1.89%)  0/52 (0.00%) 
Eye disorders       
Eye disorders - Other, specify  1  0/53 (0.00%)  0/53 (0.00%)  1/52 (1.92%) 
Gastrointestinal disorders       
Abdominal pain  1  0/53 (0.00%)  1/53 (1.89%)  1/52 (1.92%) 
Colonic perforation  1  0/53 (0.00%)  0/53 (0.00%)  1/52 (1.92%) 
Diarrhea  1  0/53 (0.00%)  3/53 (5.66%)  6/52 (11.54%) 
Dysphagia  1  0/53 (0.00%)  0/53 (0.00%)  2/52 (3.85%) 
Esophagitis  1  0/53 (0.00%)  1/53 (1.89%)  2/52 (3.85%) 
Mucositis oral  1  1/53 (1.89%)  0/53 (0.00%)  4/52 (7.69%) 
Nausea  1  6/53 (11.32%)  6/53 (11.32%)  11/52 (21.15%) 
Pancreatitis  1  0/53 (0.00%)  0/53 (0.00%)  1/52 (1.92%) 
Upper gastrointestinal hemorrhage  1  0/53 (0.00%)  1/53 (1.89%)  0/52 (0.00%) 
Vomiting  1  5/53 (9.43%)  3/53 (5.66%)  7/52 (13.46%) 
Gastrointestinal disorders - Other  1  0/53 (0.00%)  1/53 (1.89%)  0/52 (0.00%) 
General disorders       
Fatigue  1  13/53 (24.53%)  6/53 (11.32%)  12/52 (23.08%) 
Fever  1  1/53 (1.89%)  0/53 (0.00%)  0/52 (0.00%) 
Infections and infestations       
Abdominal infection  1  0/53 (0.00%)  1/53 (1.89%)  0/52 (0.00%) 
Bronchial infection  1  0/53 (0.00%)  0/53 (0.00%)  1/52 (1.92%) 
Esophageal infection  1  0/53 (0.00%)  0/53 (0.00%)  1/52 (1.92%) 
Lung infection  1  2/53 (3.77%)  3/53 (5.66%)  1/52 (1.92%) 
Sepsis  1  0/53 (0.00%)  1/53 (1.89%)  2/52 (3.85%) 
Upper respiratory infection  1  1/53 (1.89%)  0/53 (0.00%)  0/52 (0.00%) 
Urinary tract infection  1  1/53 (1.89%)  1/53 (1.89%)  2/52 (3.85%) 
Infections and infestations - Other  1  2/53 (3.77%)  0/53 (0.00%)  2/52 (3.85%) 
Injury, poisoning and procedural complications       
Fall  1  2/53 (3.77%)  0/53 (0.00%)  0/52 (0.00%) 
Fracture  1  0/53 (0.00%)  1/53 (1.89%)  0/52 (0.00%) 
Investigations       
Alanine aminotransferase increased  1  1/53 (1.89%)  0/53 (0.00%)  0/52 (0.00%) 
Creatinine increased  1  0/53 (0.00%)  1/53 (1.89%)  2/52 (3.85%) 
INR increased  1  0/53 (0.00%)  1/53 (1.89%)  0/52 (0.00%) 
Lipase increased  1  0/53 (0.00%)  1/53 (1.89%)  1/52 (1.92%) 
Lymphocyte count decreased  1  4/53 (7.55%)  1/53 (1.89%)  3/52 (5.77%) 
Neutrophil count decreased  1  26/53 (49.06%)  28/53 (52.83%)  31/52 (59.62%) 
Platelet count decreased  1  12/53 (22.64%)  3/53 (5.66%)  13/52 (25.00%) 
Weight loss  1  0/53 (0.00%)  3/53 (5.66%)  3/52 (5.77%) 
White blood cell decreased  1  25/53 (47.17%)  23/53 (43.40%)  27/52 (51.92%) 
Metabolism and nutrition disorders       
Acidosis  1  0/53 (0.00%)  1/53 (1.89%)  0/52 (0.00%) 
Anorexia  1  4/53 (7.55%)  2/53 (3.77%)  6/52 (11.54%) 
Dehydration  1  7/53 (13.21%)  2/53 (3.77%)  7/52 (13.46%) 
Glucose intolerance  1  0/53 (0.00%)  0/53 (0.00%)  1/52 (1.92%) 
Hyperglycemia  1  1/53 (1.89%)  0/53 (0.00%)  4/52 (7.69%) 
Hyperkalemia  1  1/53 (1.89%)  0/53 (0.00%)  0/52 (0.00%) 
Hyperuricemia  1  1/53 (1.89%)  0/53 (0.00%)  0/52 (0.00%) 
Hypocalcemia  1  1/53 (1.89%)  1/53 (1.89%)  1/52 (1.92%) 
Hypokalemia  1  5/53 (9.43%)  1/53 (1.89%)  3/52 (5.77%) 
Hypomagnesemia  1  0/53 (0.00%)  0/53 (0.00%)  2/52 (3.85%) 
Hyponatremia  1  7/53 (13.21%)  7/53 (13.21%)  8/52 (15.38%) 
Hypophosphatemia  1  0/53 (0.00%)  2/53 (3.77%)  2/52 (3.85%) 
Tumor lysis syndrome  1  1/53 (1.89%)  0/53 (0.00%)  0/52 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/53 (0.00%)  1/53 (1.89%)  0/52 (0.00%) 
Chest wall pain  1  0/53 (0.00%)  1/53 (1.89%)  0/52 (0.00%) 
Generalized muscle weakness  1  2/53 (3.77%)  1/53 (1.89%)  2/52 (3.85%) 
Myalgia  1  0/53 (0.00%)  1/53 (1.89%)  0/52 (0.00%) 
Musculoskeletal and connective - Other  1  0/53 (0.00%)  1/53 (1.89%)  0/52 (0.00%) 
Nervous system disorders       
Acoustic nerve disorder NOS  1  0/53 (0.00%)  0/53 (0.00%)  1/52 (1.92%) 
Cognitive disturbance  1  1/53 (1.89%)  0/53 (0.00%)  0/52 (0.00%) 
Dizziness  1  0/53 (0.00%)  0/53 (0.00%)  1/52 (1.92%) 
Headache  1  0/53 (0.00%)  1/53 (1.89%)  0/52 (0.00%) 
Peripheral sensory neuropathy  1  0/53 (0.00%)  0/53 (0.00%)  1/52 (1.92%) 
Syncope  1  1/53 (1.89%)  0/53 (0.00%)  0/52 (0.00%) 
Psychiatric disorders       
Confusion  1  1/53 (1.89%)  0/53 (0.00%)  0/52 (0.00%) 
Delirium  1  0/53 (0.00%)  1/53 (1.89%)  0/52 (0.00%) 
Insomnia  1  0/53 (0.00%)  1/53 (1.89%)  0/52 (0.00%) 
Suicide attempt  1  0/53 (0.00%)  1/53 (1.89%)  0/52 (0.00%) 
Renal and urinary disorders       
Acute kidney injury  1  3/53 (5.66%)  0/53 (0.00%)  3/52 (5.77%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnea  1  2/53 (3.77%)  1/53 (1.89%)  1/52 (1.92%) 
Hypoxia  1  1/53 (1.89%)  0/53 (0.00%)  0/52 (0.00%) 
Pleural effusion  1  0/53 (0.00%)  0/53 (0.00%)  1/52 (1.92%) 
Respiratory failure  1  1/53 (1.89%)  0/53 (0.00%)  0/52 (0.00%) 
Sore throat  1  0/53 (0.00%)  1/53 (1.89%)  0/52 (0.00%) 
Wheezing  1  0/53 (0.00%)  0/53 (0.00%)  1/52 (1.92%) 
Skin and subcutaneous tissue disorders       
Rash acneiform  1  0/53 (0.00%)  1/53 (1.89%)  0/52 (0.00%) 
Rash maculo-papular  1  0/53 (0.00%)  0/53 (0.00%)  1/52 (1.92%) 
Vascular disorders       
Hypertension  1  0/53 (0.00%)  2/53 (3.77%)  0/52 (0.00%) 
Hypotension  1  3/53 (5.66%)  0/53 (0.00%)  1/52 (1.92%) 
Thromboembolic event  1  2/53 (3.77%)  1/53 (1.89%)  1/52 (1.92%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 4.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A (CE) Arm B (CE+GDC-0449) Arm C (CE+IMC-A12)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   52/53 (98.11%)   52/53 (98.11%)   51/52 (98.08%) 
Blood and lymphatic system disorders       
Anemia  1  39/53 (73.58%)  43/53 (81.13%)  46/52 (88.46%) 
Cardiac disorders       
Atrial fibrillation  1  1/53 (1.89%)  3/53 (5.66%)  0/52 (0.00%) 
Ear and labyrinth disorders       
Hearing impaired  1  0/53 (0.00%)  4/53 (7.55%)  2/52 (3.85%) 
Tinnitus  1  4/53 (7.55%)  5/53 (9.43%)  6/52 (11.54%) 
Eye disorders       
Blurred vision  1  2/53 (3.77%)  2/53 (3.77%)  5/52 (9.62%) 
Gastrointestinal disorders       
Abdominal pain  1  1/53 (1.89%)  6/53 (11.32%)  5/52 (9.62%) 
Constipation  1  18/53 (33.96%)  20/53 (37.74%)  18/52 (34.62%) 
Diarrhea  1  12/53 (22.64%)  15/53 (28.30%)  21/52 (40.38%) 
Dyspepsia  1  2/53 (3.77%)  5/53 (9.43%)  3/52 (5.77%) 
Mucositis oral  1  10/53 (18.87%)  8/53 (15.09%)  23/52 (44.23%) 
Nausea  1  33/53 (62.26%)  31/53 (58.49%)  35/52 (67.31%) 
Vomiting  1  19/53 (35.85%)  16/53 (30.19%)  19/52 (36.54%) 
General disorders       
Chills  1  4/53 (7.55%)  2/53 (3.77%)  2/52 (3.85%) 
Edema limbs  1  3/53 (5.66%)  4/53 (7.55%)  3/52 (5.77%) 
Fatigue  1  38/53 (71.70%)  46/53 (86.79%)  42/52 (80.77%) 
Fever  1  4/53 (7.55%)  1/53 (1.89%)  1/52 (1.92%) 
Infections and infestations       
Mucosal infection  1  0/53 (0.00%)  3/53 (5.66%)  2/52 (3.85%) 
Urinary tract infection  1  2/53 (3.77%)  2/53 (3.77%)  3/52 (5.77%) 
Investigations       
Alanine aminotransferase increased  1  2/53 (3.77%)  8/53 (15.09%)  12/52 (23.08%) 
Alkaline phosphatase increased  1  7/53 (13.21%)  10/53 (18.87%)  11/52 (21.15%) 
Aspartate aminotransferase increased  1  1/53 (1.89%)  5/53 (9.43%)  11/52 (21.15%) 
Blood bilirubin increased  1  1/53 (1.89%)  1/53 (1.89%)  3/52 (5.77%) 
Creatinine increased  1  7/53 (13.21%)  10/53 (18.87%)  18/52 (34.62%) 
Lymphocyte count decreased  1  5/53 (9.43%)  6/53 (11.32%)  5/52 (9.62%) 
Neutrophil count decreased  1  12/53 (22.64%)  14/53 (26.42%)  11/52 (21.15%) 
Platelet count decreased  1  28/53 (52.83%)  23/53 (43.40%)  34/52 (65.38%) 
Weight loss  1  20/53 (37.74%)  26/53 (49.06%)  35/52 (67.31%) 
White blood cell decreased  1  30/53 (56.60%)  19/53 (35.85%)  31/52 (59.62%) 
Investigations - Other, specify  1  1/53 (1.89%)  2/53 (3.77%)  5/52 (9.62%) 
Metabolism and nutrition disorders       
Anorexia  1  26/53 (49.06%)  31/53 (58.49%)  32/52 (61.54%) 
Dehydration  1  8/53 (15.09%)  4/53 (7.55%)  13/52 (25.00%) 
Hypercalcemia  1  1/53 (1.89%)  3/53 (5.66%)  3/52 (5.77%) 
Hyperglycemia  1  6/53 (11.32%)  12/53 (22.64%)  30/52 (57.69%) 
Hyperkalemia  1  2/53 (3.77%)  3/53 (5.66%)  7/52 (13.46%) 
Hypoalbuminemia  1  7/53 (13.21%)  11/53 (20.75%)  16/52 (30.77%) 
Hypocalcemia  1  9/53 (16.98%)  6/53 (11.32%)  19/52 (36.54%) 
Hypokalemia  1  9/53 (16.98%)  10/53 (18.87%)  9/52 (17.31%) 
Hypomagnesemia  1  19/53 (35.85%)  21/53 (39.62%)  21/52 (40.38%) 
Hyponatremia  1  17/53 (32.08%)  14/53 (26.42%)  17/52 (32.69%) 
Hypophosphatemia  1  7/53 (13.21%)  5/53 (9.43%)  4/52 (7.69%) 
Metabolism and nutrition - Other  1  2/53 (3.77%)  2/53 (3.77%)  3/52 (5.77%) 
Musculoskeletal and connective tissue disorders       
Generalized muscle weakness  1  3/53 (5.66%)  6/53 (11.32%)  8/52 (15.38%) 
Myalgia  1  2/53 (3.77%)  4/53 (7.55%)  4/52 (7.69%) 
Pain in extremity  1  2/53 (3.77%)  4/53 (7.55%)  3/52 (5.77%) 
Musculoskeletal and connective - Other  1  0/53 (0.00%)  5/53 (9.43%)  0/52 (0.00%) 
Nervous system disorders       
Dizziness  1  8/53 (15.09%)  9/53 (16.98%)  13/52 (25.00%) 
Dysgeusia  1  10/53 (18.87%)  18/53 (33.96%)  13/52 (25.00%) 
Headache  1  9/53 (16.98%)  6/53 (11.32%)  7/52 (13.46%) 
Peripheral sensory neuropathy  1  7/53 (13.21%)  10/53 (18.87%)  8/52 (15.38%) 
Psychiatric disorders       
Insomnia  1  7/53 (13.21%)  3/53 (5.66%)  3/52 (5.77%) 
Renal and urinary disorders       
Chronic kidney disease  1  1/53 (1.89%)  3/53 (5.66%)  1/52 (1.92%) 
Respiratory, thoracic and mediastinal disorders       
Allergic rhinitis  1  2/53 (3.77%)  2/53 (3.77%)  4/52 (7.69%) 
Cough  1  3/53 (5.66%)  4/53 (7.55%)  2/52 (3.85%) 
Dyspnea  1  6/53 (11.32%)  6/53 (11.32%)  7/52 (13.46%) 
Epistaxis  1  3/53 (5.66%)  0/53 (0.00%)  4/52 (7.69%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  37/53 (69.81%)  34/53 (64.15%)  40/52 (76.92%) 
Dry skin  1  0/53 (0.00%)  1/53 (1.89%)  4/52 (7.69%) 
Pruritus  1  4/53 (7.55%)  1/53 (1.89%)  3/52 (5.77%) 
Rash acneiform  1  1/53 (1.89%)  5/53 (9.43%)  4/52 (7.69%) 
Rash maculo-papular  1  3/53 (5.66%)  5/53 (9.43%)  6/52 (11.54%) 
Vascular disorders       
Hypertension  1  1/53 (1.89%)  2/53 (3.77%)  3/52 (5.77%) 
Hypotension  1  7/53 (13.21%)  5/53 (9.43%)  6/52 (11.54%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 4.0
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
Layout table for Results Point of Contact information
Name/Title: Study statistician
Organization: ECOG-ACRIN Statistical Office
Phone: 617-632-6012
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00887159     History of Changes
Other Study ID Numbers: NCI-2011-01917
NCI-2011-01917 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
09-0679
ECOG-E1508
CDR0000640898
E1508 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
E1508 ( Other Identifier: CTEP )
U10CA180820 ( U.S. NIH Grant/Contract )
U10CA021115 ( U.S. NIH Grant/Contract )
First Submitted: April 22, 2009
First Posted: April 23, 2009
Results First Submitted: July 1, 2015
Results First Posted: July 29, 2015
Last Update Posted: April 20, 2018