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Trial record 2 of 6 for:    sargramostim ipilimumab melanoma

Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

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: NCT01134614
Recruitment Status : Active, not recruiting
First Posted : June 2, 2010
Results First Posted : April 2, 2015
Last Update Posted : April 14, 2021
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 Advanced Melanoma
Metastatic Melanoma
Recurrent Melanoma
Stage III Cutaneous Melanoma AJCC v7
Stage IIIA Cutaneous Melanoma AJCC v7
Stage IIIB Cutaneous Melanoma AJCC v7
Stage IIIC Cutaneous Melanoma AJCC v7
Stage IV Cutaneous Melanoma AJCC v6 and v7
Unresectable Melanoma
Interventions Biological: Ipilimumab
Biological: Sargramostim
Enrollment 245
Recruitment Details Participants were enrolled from ECOG member institutions between December 28, 2010 and July 28, 2011.
Pre-assignment Details  
Arm/Group Title Arm A (Ipilimumab and Sargramostim) Arm B (Ipilimumab)
Hide Arm/Group Description

ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, anti-tumor response is assessed and patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.

ipilimumab: Given IV

sargramostim: Given SC

ARM B: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, anti-tumor response is assessed and patients then receive maintenance therapy of ipilimumab IV over 90 minutes on day 1. Treatment with ipilimumab repeats every 12 weeks. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.

ipilimumab: Given IV

Period Title: Overall Study
Started 123 122
Treated 119 121
Treated and Toxicity Assessed 118 120
Completed 0 [1] 0 [2]
Not Completed 123 122
Reason Not Completed
Still on treatment as of March 2013             21             13
Progressive disease             60             54
Adverse Event             26             39
Death             5             8
Withdrawal by Subject             3             2
Alternative therapy             2             0
Complicating disease             2             1
Physician's decision             0             1
Never started treatment             4             1
Pt received tx not allowed on study             0             1
Symptomatic deterioration             0             1
Patient in hospice care             0             1
[1]
Treatment continues until disease progression or unacceptable toxicity.
[2]
Treatment continues until disease progression or unacceptable toxicities
Arm/Group Title Arm A (Ipilimumab and Sargramostim) Arm B (Ipilimumab) Total
Hide Arm/Group Description

ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.

ipilimumab: Given IV

sargramostim: Given SC

ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.

ipilimumab: Given IV

Total of all reporting groups
Overall Number of Baseline Participants 123 122 245
Hide Baseline Analysis Population Description
All randomized patients are included in this analysis.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 123 participants 122 participants 245 participants
61
(25 to 86)
64
(21 to 89)
63
(21 to 89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants 122 participants 245 participants
Female
38
  30.9%
44
  36.1%
82
  33.5%
Male
85
  69.1%
78
  63.9%
163
  66.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 123 participants 122 participants 245 participants
123 122 245
1.Primary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the time from randomization to death from any cause.
Time Frame Assessed every 3 months for 2 years, then every 6 months for 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients are included in this analysis.
Arm/Group Title Arm A (Ipilimumab and Sargramostim) Arm B (Ipilimumab)
Hide Arm/Group Description:

ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.

ipilimumab: Given IV

sargramostim: Given SC

ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.

ipilimumab: Given IV

Overall Number of Participants Analyzed 123 122
Median (95% Confidence Interval)
Unit of Measure: Months
17.5 [1] 
(14.9 to NA)
12.7 [1] 
(10.0 to NA)
[1]
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
2.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description Progression-free survival is defined as the time from randomization to disease progression or death, whichever occurs first. Response and disease progression will be evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Disease progression is defined as >= 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) and the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions is also considered progression.
Time Frame Assessed every 3 months for 2 years, then every 6 months for 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients are included in this analysis.
Arm/Group Title Arm A (Ipilimumab and Sargramostim) Arm B (Ipilimumab)
Hide Arm/Group Description:

ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.

ipilimumab: Given IV

sargramostim: Given SC

ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.

ipilimumab: Given IV

Overall Number of Participants Analyzed 123 122
Median (95% Confidence Interval)
Unit of Measure: Months
3.1
(2.9 to 4.6)
3.1
(2.9 to 4.0)
3.Secondary Outcome
Title Proportion of Patients With Objective Response
Hide Description Objective response was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). Partial response (PR)= At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. To be assigned a status of partial response, changes in tumor measurements must be confirmed by a repeat assessment performed no less than four weeks after the criteria for response is met. Objective response = CR + PR.
Time Frame Assessed every 3 months for 2 years, then every 6 months for 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients are included in this analysis.
Arm/Group Title Arm A (Ipilimumab and Sargramostim) Arm B (Ipilimumab)
Hide Arm/Group Description:

ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.

ipilimumab: Given IV

sargramostim: Given SC

ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.

ipilimumab: Given IV

Overall Number of Participants Analyzed 123 122
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of patients
0.155
(0.096 to 0.231)
0.148
(0.090 to 0.223)
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 (Ipilimumab and Sargramostim) Arm B (Ipilimumab)
Hide Arm/Group Description ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity. ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Arm A (Ipilimumab and Sargramostim) Arm B (Ipilimumab)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Arm A (Ipilimumab and Sargramostim) Arm B (Ipilimumab)
Affected / at Risk (%) Affected / at Risk (%)
Total   56/118 (47.46%)   69/120 (57.50%) 
Blood and lymphatic system disorders     
Anemia  1  0/118 (0.00%)  1/120 (0.83%) 
Febrile neutropenia  1  1/118 (0.85%)  0/120 (0.00%) 
Cardiac disorders     
Cardiac arrest  1  1/118 (0.85%)  0/120 (0.00%) 
Ventricular tachycardia  1  0/118 (0.00%)  1/120 (0.83%) 
Endocrine disorders     
Adrenal insufficiency  1  2/118 (1.69%)  2/120 (1.67%) 
Hyperthyroidism  1  0/118 (0.00%)  1/120 (0.83%) 
Hypothyroidism  1  0/118 (0.00%)  2/120 (1.67%) 
Endocrine disorders - Other, specify  1  3/118 (2.54%)  5/120 (4.17%) 
Eye disorders     
Eye disorders - Other, specify  1  1/118 (0.85%)  2/120 (1.67%) 
Gastrointestinal disorders     
Abdominal distension  1  0/118 (0.00%)  1/120 (0.83%) 
Abdominal pain  1  1/118 (0.85%)  4/120 (3.33%) 
Colitis  1  7/118 (5.93%)  12/120 (10.00%) 
Colonic hemorrhage  1  1/118 (0.85%)  0/120 (0.00%) 
Colonic perforation  1  2/118 (1.69%)  7/120 (5.83%) 
Diarrhea  1  14/118 (11.86%)  15/120 (12.50%) 
Enterocolitis  1  0/118 (0.00%)  1/120 (0.83%) 
Nausea  1  3/118 (2.54%)  4/120 (3.33%) 
Rectal hemorrhage  1  0/118 (0.00%)  1/120 (0.83%) 
Vomiting  1  1/118 (0.85%)  3/120 (2.50%) 
General disorders     
Fatigue  1  7/118 (5.93%)  4/120 (3.33%) 
Fever  1  1/118 (0.85%)  0/120 (0.00%) 
Infusion related reaction  1  0/118 (0.00%)  1/120 (0.83%) 
Injection site reaction  1  2/118 (1.69%)  0/120 (0.00%) 
Multi-organ failure  1  0/118 (0.00%)  2/120 (1.67%) 
Pain  1  0/118 (0.00%)  1/120 (0.83%) 
Hepatobiliary disorders     
Hepatic failure  1  0/118 (0.00%)  1/120 (0.83%) 
Hepatobiliary disorders - Other, specify  1  1/118 (0.85%)  0/120 (0.00%) 
Immune system disorders     
Allergic reaction  1  1/118 (0.85%)  0/120 (0.00%) 
Autoimmune disorder  1  0/118 (0.00%)  5/120 (4.17%) 
Immune system disorders - Other, specify  1  0/118 (0.00%)  1/120 (0.83%) 
Infections and infestations     
Enterocolitis infectious  1  1/118 (0.85%)  1/120 (0.83%) 
Kidney infection  1  0/118 (0.00%)  1/120 (0.83%) 
Lung infection  1  0/118 (0.00%)  2/120 (1.67%) 
Sepsis  1  1/118 (0.85%)  0/120 (0.00%) 
Injury, poisoning and procedural complications     
Fall  1  1/118 (0.85%)  0/120 (0.00%) 
Investigations     
Activated PTT prolonged  1  0/118 (0.00%)  1/120 (0.83%) 
Alanine aminotransferase increased  1  6/118 (5.08%)  8/120 (6.67%) 
Alkaline phosphatase increased  1  0/118 (0.00%)  3/120 (2.50%) 
Aspartate aminotransferase increased  1  5/118 (4.24%)  9/120 (7.50%) 
Blood bilirubin increased  1  0/118 (0.00%)  4/120 (3.33%) 
Creatinine increased  1  1/118 (0.85%)  0/120 (0.00%) 
INR increased  1  0/118 (0.00%)  1/120 (0.83%) 
Lipase increased  1  6/118 (5.08%)  6/120 (5.00%) 
Lymphocyte count decreased  1  1/118 (0.85%)  2/120 (1.67%) 
Neutrophil count decreased  1  2/118 (1.69%)  1/120 (0.83%) 
Platelet count decreased  1  2/118 (1.69%)  2/120 (1.67%) 
Serum amylase increased  1  2/118 (1.69%)  1/120 (0.83%) 
White blood cell decreased  1  0/118 (0.00%)  1/120 (0.83%) 
Investigations - Other, specify  1  0/118 (0.00%)  1/120 (0.83%) 
Metabolism and nutrition disorders     
Anorexia  1  2/118 (1.69%)  2/120 (1.67%) 
Dehydration  1  5/118 (4.24%)  5/120 (4.17%) 
Hyperkalemia  1  1/118 (0.85%)  0/120 (0.00%) 
Hyperuricemia  1  2/118 (1.69%)  0/120 (0.00%) 
Hypoalbuminemia  1  0/118 (0.00%)  2/120 (1.67%) 
Hypokalemia  1  2/118 (1.69%)  0/120 (0.00%) 
Hyponatremia  1  5/118 (4.24%)  3/120 (2.50%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/118 (1.69%)  1/120 (0.83%) 
Arthritis  1  1/118 (0.85%)  0/120 (0.00%) 
Back pain  1  0/118 (0.00%)  1/120 (0.83%) 
Bone pain  1  0/118 (0.00%)  1/120 (0.83%) 
Generalized muscle weakness  1  2/118 (1.69%)  4/120 (3.33%) 
Joint range of motion decreased  1  1/118 (0.85%)  1/120 (0.83%) 
Muscle weakness lower limb  1  1/118 (0.85%)  1/120 (0.83%) 
Myalgia  1  1/118 (0.85%)  1/120 (0.83%) 
Pain in extremity  1  1/118 (0.85%)  0/120 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor Pain  1  0/118 (0.00%)  1/120 (0.83%) 
Nervous system disorders     
Headache  1  2/118 (1.69%)  0/120 (0.00%) 
Syncope  1  2/118 (1.69%)  0/120 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  0/118 (0.00%)  1/120 (0.83%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  0/118 (0.00%)  2/120 (1.67%) 
Hypoxia  1  0/118 (0.00%)  1/120 (0.83%) 
Pleural effusion  1  0/118 (0.00%)  1/120 (0.83%) 
Pneumonitis  1  0/118 (0.00%)  2/120 (1.67%) 
Respiratory failure  1  0/118 (0.00%)  3/120 (2.50%) 
Skin and subcutaneous tissue disorders     
Dry skin  1  1/118 (0.85%)  0/120 (0.00%) 
Pruritus  1  4/118 (3.39%)  7/120 (5.83%) 
Rash acneiform  1  0/118 (0.00%)  1/120 (0.83%) 
Rash maculo-papular  1  14/118 (11.86%)  11/120 (9.17%) 
Urticaria  1  1/118 (0.85%)  1/120 (0.83%) 
Vascular disorders     
Hypertension  1  0/118 (0.00%)  2/120 (1.67%) 
Hypotension  1  2/118 (1.69%)  2/120 (1.67%) 
Thromboembolic event  1  1/118 (0.85%)  1/120 (0.83%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 4.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A (Ipilimumab and Sargramostim) Arm B (Ipilimumab)
Affected / at Risk (%) Affected / at Risk (%)
Total   110/118 (93.22%)   111/120 (92.50%) 
Blood and lymphatic system disorders     
Anemia  1  22/118 (18.64%)  24/120 (20.00%) 
Endocrine disorders     
Adrenal insufficiency  1  7/118 (5.93%)  2/120 (1.67%) 
Hypothyroidism  1  11/118 (9.32%)  6/120 (5.00%) 
Gastrointestinal disorders     
Abdominal pain  1  20/118 (16.95%)  16/120 (13.33%) 
Constipation  1  7/118 (5.93%)  9/120 (7.50%) 
Diarrhea  1  46/118 (38.98%)  46/120 (38.33%) 
Nausea  1  36/118 (30.51%)  31/120 (25.83%) 
Vomiting  1  10/118 (8.47%)  6/120 (5.00%) 
General disorders     
Chills  1  18/118 (15.25%)  8/120 (6.67%) 
Edema limbs  1  10/118 (8.47%)  4/120 (3.33%) 
Fatigue  1  70/118 (59.32%)  75/120 (62.50%) 
Fever  1  17/118 (14.41%)  18/120 (15.00%) 
Injection site reaction  1  62/118 (52.54%)  0/120 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  13/118 (11.02%)  18/120 (15.00%) 
Alkaline phosphatase increased  1  12/118 (10.17%)  12/120 (10.00%) 
Aspartate aminotransferase increased  1  16/118 (13.56%)  21/120 (17.50%) 
Blood bilirubin increased  1  6/118 (5.08%)  6/120 (5.00%) 
Creatinine increased  1  6/118 (5.08%)  8/120 (6.67%) 
Lipase increased  1  13/118 (11.02%)  7/120 (5.83%) 
Lymphocyte count decreased  1  6/118 (5.08%)  9/120 (7.50%) 
Platelet count decreased  1  9/118 (7.63%)  4/120 (3.33%) 
Weight loss  1  16/118 (13.56%)  17/120 (14.17%) 
Investigations - Other, specify  1  7/118 (5.93%)  7/120 (5.83%) 
Metabolism and nutrition disorders     
Anorexia  1  25/118 (21.19%)  33/120 (27.50%) 
Hyperuricemia  1  6/118 (5.08%)  1/120 (0.83%) 
Hypoalbuminemia  1  7/118 (5.93%)  6/120 (5.00%) 
Hypocalcemia  1  6/118 (5.08%)  2/120 (1.67%) 
Hyponatremia  1  9/118 (7.63%)  4/120 (3.33%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  20/118 (16.95%)  13/120 (10.83%) 
Back pain  1  10/118 (8.47%)  10/120 (8.33%) 
Bone pain  1  8/118 (6.78%)  2/120 (1.67%) 
Myalgia  1  9/118 (7.63%)  5/120 (4.17%) 
Pain in extremity  1  8/118 (6.78%)  1/120 (0.83%) 
Nervous system disorders     
Dizziness  1  11/118 (9.32%)  5/120 (4.17%) 
Dysgeusia  1  7/118 (5.93%)  7/120 (5.83%) 
Headache  1  23/118 (19.49%)  10/120 (8.33%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  6/118 (5.08%)  10/120 (8.33%) 
Dyspnea  1  9/118 (7.63%)  11/120 (9.17%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  50/118 (42.37%)  54/120 (45.00%) 
Rash maculo-papular  1  62/118 (52.54%)  57/120 (47.50%) 
Skin and subcutaneous tissue - Other  1  7/118 (5.93%)  1/120 (0.83%) 
Vascular disorders     
Hot flashes  1  8/118 (6.78%)  7/120 (5.83%) 
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 Statistical Office
Phone: 617-632-3012
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01134614    
Other Study ID Numbers: NCI-2011-02039
NCI-2011-02039 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000671238
E1608
11-01460
E1608 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
E1608 ( Other Identifier: CTEP )
U10CA180820 ( U.S. NIH Grant/Contract )
U10CA021115 ( U.S. NIH Grant/Contract )
First Submitted: April 27, 2010
First Posted: June 2, 2010
Results First Submitted: March 23, 2015
Results First Posted: April 2, 2015
Last Update Posted: April 14, 2021