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Trial record 19 of 31 for:    IGFBP2

Bicalutamide and Goserelin or Leuprolide Acetate With or Without Cixutumumab in Treating Patients With Newly Diagnosed Metastatic Prostate Cancer

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: NCT01120236
Recruitment Status : Completed
First Posted : May 10, 2010
Results First Posted : October 6, 2016
Last Update Posted : February 26, 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 Prostate Adenocarcinoma
Recurrent Prostate Carcinoma
Stage IV Prostate Cancer
Interventions Drug: Bicalutamide
Biological: Cixutumumab
Drug: Goserelin Acetate
Other: Laboratory Biomarker Analysis
Drug: Leuprolide Acetate
Other: Pharmacological Study
Enrollment 211
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Androgen Deprivation and Cixutumumab) Arm II (Androgen Deprivation Therapy)
Hide Arm/Group Description

Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.

Bicalutamide: Given PO

Cixutumumab: Given IV

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given IM

Pharmacological Study: Correlative studies

Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.

Bicalutamide: Given PO

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given IM

Pharmacological Study: Correlative studies

Period Title: Overall Study
Started 105 106
Ineligble 0 1 [1]
Completed 105 105
Not Completed 0 1
[1]
Patient ineligible due to no demonstable radiographic metastasis and is excluded from all analyses.
Arm/Group Title Arm I (Androgen Deprivation and Cixutumumab) Arm II (Androgen Deprivation Therapy) Total
Hide Arm/Group Description

Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.

Bicalutamide: Given PO

Cixutumumab: Given IV

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given IM

Pharmacological Study: Correlative studies

Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.

Bicalutamide: Given PO

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given IM

Pharmacological Study: Correlative studies

Total of all reporting groups
Overall Number of Baseline Participants 105 105 210
Hide Baseline Analysis Population Description
One patient from Arm II (androgen deprivation therapy) was ineligible because of lack of a demonstrable radiographic metastasis. This patient was excluded from analyses.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 105 participants 105 participants 210 participants
65
(60 to 72)
66
(58 to 73)
66
(59 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants 105 participants 210 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
105
 100.0%
105
 100.0%
210
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 105 participants 105 participants 210 participants
Black 4 10 14
White 94 88 182
Other 7 7 14
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 105 participants 105 participants 210 participants
105 105 210
Prostate-Specific Antigen (PSA)  
Median (Inter-Quartile Range)
Unit of measure:  ng/mL
Number Analyzed 105 participants 105 participants 210 participants
31
(12 to 74)
37
(10 to 200)
34
(11 to 133)
Weight  
Median (Inter-Quartile Range)
Unit of measure:  Kg
Number Analyzed 105 participants 105 participants 210 participants
90
(79 to 101)
86
(77 to 98)
88
(77 to 100)
Body Mass Index (BMI)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 105 participants 105 participants 210 participants
<18.5 (underweight) 1 2 3
18.5 to 24.9 (normal weight) 21 29 50
25 to 29.9 (overweight) 36 39 75
>= 30 (obese) 43 33 76
Unknown 4 2 6
Gleason Score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 105 participants 105 participants 210 participants
<7 8 6 14
7 29 11 40
>=7 63 82 145
Unknown 5 6 11
[1]
Measure Description: This is a 2 to 10 grading system for prostate carcinoma devised by Dr. Donald Gleason in 1977 as a method for predicting the behavior of prostate cancer. Tumors with a low Gleason score are less likely to show aggressive behavior and therefore are less likely to have spread outside of the gland to lymph nodes. To obtain a Gleason score, the dominant tumor pattern is added to the second most prevalent pattern to obtain a number between 2 and 10. If a tumor has patterns 3 and 2, the score would be 5. If the tumor has only one pattern, then the single pattern is added to itself (e.g. 3+3=6).
Zubrod Performance Score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 105 participants 105 participants 210 participants
0 62 65 127
1 41 38 79
2 2 2 4
[1]
Measure Description:

Scale 0 (best) to 2 (worst)

0 = Fully active, able to carry on all pre-disease performance without restriction.

  1. = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work.
  2. = Ambulatory and capable of self-care but unable to carry out any work activities; up and about more than 50% of waking hours.
Site of Metastasis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 105 participants 105 participants 210 participants
Lymph Node Only 15 9 24
Bone Only 56 63 119
Lymph Node and Bone 19 17 36
Visceral 15 16 31
Bone Pain  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 105 participants 105 participants 210 participants
28 35 63
Early Induction Androgen Deprivation   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 105 participants 105 participants 210 participants
59 65 124
[1]
Measure Description: Prior remote AD was allowed only if received in the neoadjuvant, concurrent, and/or adjuvant settings and > 2 years had elapsed since completion of therapy.
1.Primary Outcome
Title Undetectable PSA Rate
Hide Description Undetectable PSA rate (<= 0.2 ng/mL) after seven cycles (28 weeks) of protocol treatment
Time Frame 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
One patient from Arm II (androgen deprivation therapy) was ineligible because of lack of a demonstrable radiographic metastasis. This patient was excluded from analyses.
Arm/Group Title Arm I (Androgen Deprivation and Cixutumumab) Arm II (Androgen Deprivation Therapy)
Hide Arm/Group Description:

Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.

Bicalutamide: Given PO

Cixutumumab: Given IV

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given IM

Pharmacological Study: Correlative studies

Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.

Bicalutamide: Given PO

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given IM

Pharmacological Study: Correlative studies

Overall Number of Participants Analyzed 105 105
Measure Type: Number
Unit of Measure: participants
42 34
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Androgen Deprivation and Cixutumumab), Arm II (Androgen Deprivation Therapy)
Comments An intention-to-treat approach was used in analysis of the primary endpoint. A 45% undetectable PSA <= 0.2 ng/mL rate at 28 weeks was assumed for (control) arm II , based on data from SWOG 9346. Using a one-sided type I error rate of 0.10, we had 90% statistical power to detect an absolute difference of 20% in the undetectable PSA rate with the addition of cixutumumab using Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.24
Estimation Comments Arm I (Androgen Deprivation and Cixutumumab) represents the numerator and Arm II (Androgen Deprivation Therapy) represents the denominator for relative risk.
2.Secondary Outcome
Title Toxicity
Hide Description Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame Up to 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving at least some protocol treatment were included in toxicity analysis. Four patients on Arm I (androgen deprivation and cixutumumab) and two patients on Arm II (androgen deprivation therapy) did not receive any protocol treatment and were therefore excluded from this analysis.
Arm/Group Title Arm I (Androgen Deprivation and Cixutumumab) Arm II (Androgen Deprivation Therapy)
Hide Arm/Group Description:

Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.

Bicalutamide: Given PO Cixutumumab: Given IV Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given IM Pharmacological Study: Correlative studies

Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.

Bicalutamide: Given PO Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given IM Pharmacological Study: Correlative studies

Overall Number of Participants Analyzed 101 104
Measure Type: Number
Unit of Measure: Participants
Alanine aminotransferase increased 1 0
Anemia 1 1
Anxiety 0 1
Aspartate aminotransferase increased 1 0
Cognitive disturbance 1 0
Depression 0 1
Erectile dysfunction 1 0
Exostosis 1 0
Glucose intolerance 0 1
Hot flashes 1 1
Hypercalcemia 2 0
Hyperglycemia 8 0
Hypertension 2 2
Hypertriglyceridemia 1 0
Left ventricular systolic dysfunction 1 0
Nausea 1 0
Obesity 1 1
Soft tissue infection 1 0
Urinary tract infection 1 0
Urinary tract obstruction 0 1
Vomiting 1 0
3.Secondary Outcome
Title Proportion of Patients Who do Not Achieve a Partial PSA Response
Hide Description A partial PSA response is considered <= 4 ng/mL
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
One patient from Arm II (androgen deprivation therapy) was ineligible because of lack of a demonstrable radiographic metastasis. This patient was excluded from analyses.
Arm/Group Title Arm I (Androgen Deprivation and Cixutumumab) Arm II (Androgen Deprivation Therapy)
Hide Arm/Group Description:

Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.

Bicalutamide: Given PO

Cixutumumab: Given IV

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given IM

Pharmacological Study: Correlative studies

Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.

Bicalutamide: Given PO

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given IM

Pharmacological Study: Correlative studies

Overall Number of Participants Analyzed 105 105
Measure Type: Number
Unit of Measure: participants
46 56
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Androgen Deprivation and Cixutumumab), Arm II (Androgen Deprivation Therapy)
Comments Proportion of patients in each arm with PSA > 4 ng/mL after seven cycles of protocol treatment were compared.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.82
Estimation Comments Arm I (Androgen Deprivation and Cixutumumab) represents the numerator and Arm II (Androgen Deprivation Therapy) represents the denominator for relative risk.
4.Secondary Outcome
Title Accuracy of the Prognostic Model of Undetectable PSA (Developed From SWOG-9346)
Hide Description The logistic regression algorithm for predicting undetectable PSA that was developed for SWOG-9346 using its baseline risk factors (age at registration, performance status, baseline PSA, and bone pain) will be applied to each arm of this trial to evaluate the level of agreement between the observed and predicted undetectable PSA rates.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The data from this trial was intended to be used as a validation dataset for the prognostic model built using data from SWOG-9346. However, data for this objective was not collected.
Arm/Group Title Arm I (Androgen Deprivation and Cixutumumab) Arm II (Androgen Deprivation Therapy)
Hide Arm/Group Description:

Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.

Bicalutamide: Given PO

Cixutumumab: Given IV

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given IM

Pharmacological Study: Correlative studies

Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.

Bicalutamide: Given PO

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given IM

Pharmacological Study: Correlative studies

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Correlation of microRNA Measures With 28-week PSA Response
Hide Description The Friedman test will be used to evaluate correlations between microRNA measures (CT) and 28-week PSA response.
Time Frame Baseline to 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Among the 50 patients in this biomarker substudy, 10 patients were excluded: 1 ineligible for S0925, 6 started LHRH therapy prior to registration, 3 had insufficient miRNA samples. The remaining 40 patienets were included in this analysis.
Arm/Group Title PSA Complete Response PSA Partial Response PSA Non-Responders
Hide Arm/Group Description:
Patients who had a PSA level of ≤ 0.2 ng/mL at 28 weeks after registration, pooled treatment Arm I (androgen deprivation and cixutumumab) & Arm II (androgen deprivation therapy)
Patients who had a PSA level of >0.2 ng/mL and <= 4.0 ng/mL at 28 weeks after registration, pooled treatment Arm I (androgen deprivation and cixutumumab) & Arm II (androgen deprivation therapy)
Patients who had a PSA level of > 4.0 ng/mL at 28 weeks after registration, pooled treatment Arm I (androgen deprivation and cixutumumab) & Arm II (androgen deprivation therapy)
Overall Number of Participants Analyzed 22 5 13
Median (Full Range)
Unit of Measure: Cycle Threshold (CT)
miR-141
32.6
(29.5 to 36.8)
32.0
(31.9 to 32.7)
31.5
(27.6 to 33.5)
miR-200a
34.5
(31.4 to 39.9)
33.8
(32.4 to 35.6)
33.8
(30.1 to 40.0)
miR-200b
33.6
(32.7 to 35.0)
33.6
(32.7 to 35.0)
32.6
(29.3 to 34.8)
miR-210
32.5
(30.8 to 36.8)
32.1
(31.3 to 33.8)
32.3
(28.0 to 34.3)
miR-375
33.0
(29.3 to 35.9)
32.6
(30.0 to 35.0)
29.5
(25.7 to 33.8)
6.Secondary Outcome
Title Correlation of microRNA Measures With Baseline Circulating Tumor Cell (CTC) Counts
Hide Description The Friedman test will be used to evaluate correlations between microRNA measures (CT) and Baseline CTCs.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Among the 50 patients in this biomarker substudy, 14 patients were excluded: 1 ineligible for S0925, 6 started LHRH therapy prior to registration, 3 had insufficient miRNA samples and 4 had insufficient CTC samples. The remaining 36 patients were used in this analysis.
Arm/Group Title CTC=0 CTC= 1-4 CTC= 5+
Hide Arm/Group Description:
No CTCs foundin 7.5 mL blood sample collected at baseline, pooled treatment arms
1 to 4 CTCs found in 7.5 mL blood sample collected at baseline, pooled treatment arms
Five or more CTCs were found in 7.5 mL blood sample collected at baseline, pooled treatment arms
Overall Number of Participants Analyzed 14 8 14
Median (Full Range)
Unit of Measure: Cycle Threshold (CT)
miR-141
33.0
(31.5 to 36.8)
32.7
(31.6 to 33.7)
31.9
(28.8 to 32.5)
miR-200a
34.4
(31.4 to 39.7)
34.7
(32.1 to 37.7)
33.0
(30.1 to 40.0)
miR-200b
33.4
(32.1 to 34.2)
33.2
(32.7 to 34.1)
33.6
(29.3 to 35.0)
miR-210
32.5
(30.8 to 36.8)
32.7
(31.4 to 34.3)
32.1
(31.0 to 33.5)
miR-375
32.8
(30.1 to 35.1)
32.7
(26.5 to 35.9)
30.2
(26.7 to 35.0)
7.Secondary Outcome
Title Change in Level of CTCs
Hide Description Will be correlated with 28-week PSA response.
Time Frame Baseline to 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Among the 50 patients in this biomarker substudy, 1 was ineligible for the trial, 6 started LHRH therapy prior to registration, and 4 had CTC blood samples that were not assay evaluable. The remaining 39 patients were included in this analysis.
Arm/Group Title CTC=0 CTC= 1-4 CTC= 5+
Hide Arm/Group Description:
No CTCs foundin 7.5 mL blood sample collected at baseline, pooled treatment arms
1 to 4 CTCs found in 7.5 mL blood sample collected at baseline, pooled treatment arms
Five or more CTCs were found in 7.5 mL blood sample collected at baseline, pooled treatment arms
Overall Number of Participants Analyzed 16 9 14
Measure Type: Count of Participants
Unit of Measure: Participants
PSA <= 0.2 ng/mL
12
  75.0%
5
  55.6%
4
  28.6%
0.2 < PSA <=4.0 ng/mL
0
   0.0%
2
  22.2%
3
  21.4%
PSA > 4.0 ng/mL
4
  25.0%
2
  22.2%
7
  50.0%
8.Other Pre-specified Outcome
Title Change in Level of IGF-I, Free IGF-I and C-peptide
Hide Description Serum samples and peripheral blood mononuclear cells (PBMNC) for pharmacodynamic activity with potential biomarkers for IMC-A12 (including, but not limited to: IGF-I, free IGF-I and C-peptide) obtained from optional blood specimens both before initiation of androgen deprivation therapy and twelve weeks after initiation of combined therapy. Results are reported as the difference between baseline and 12 weeks after start of therapy.
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Androgen Deprivation and Cixutumumab) Arm II (Androgen Deprivation Therapy)
Hide Arm/Group Description:

Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.

Bicalutamide: Given PO

Cixutumumab: Given IV

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given IM

Pharmacological Study: Correlative studies

Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.

Bicalutamide: Given PO

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given IM

Pharmacological Study: Correlative studies

Overall Number of Participants Analyzed 18 9
Mean (Standard Deviation)
Unit of Measure: ng/mL
C-peptide -7  (24.5) 3  (20.1)
IGF-I 0  (2.4) 1  (2.7)
IGF-II 10  (46.7) -6  (43.7)
9.Other Pre-specified Outcome
Title Change in Level of IGFBP2, IGFBP3 and Growth Hormone
Hide Description Serum samples and peripheral blood mononuclear cells (PBMNC) for pharmacodynamic activity with potential biomarkers for IMC-A12 (including, but not limited to: IGFBP2, IGFBP3 and Growth Hormone) obtained from optional blood specimens both before initiation of androgen deprivation therapy and twelve weeks after initiation of combined therapy. Results are reported as the difference between baseline and 12 weeks after start of therapy.
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Androgen Deprivation and Cixutumumab) Arm II (Androgen Deprivation Therapy)
Hide Arm/Group Description:

Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.

Bicalutamide: Given PO

Cixutumumab: Given IV

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given IM

Pharmacological Study: Correlative studies

Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.

Bicalutamide: Given PO

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given IM

Pharmacological Study: Correlative studies

Overall Number of Participants Analyzed 18 9
Mean (Standard Deviation)
Unit of Measure: pg/mL
IGFBP-I -946  (2309.3) -904  (32362.4)
IGFBP-III 13893  (47335.2) 291  (13344.5)
GH 66  (159.9) -25  (327.8)
10.Other Pre-specified Outcome
Title Change in Level of Insulin
Hide Description Serum samples and peripheral blood mononuclear cells (PBMNC) for pharmacodynamic activity with potential biomarkers for IMC-A12 (insulin) obtained from optional blood specimens both before initiation of androgen deprivation therapy and twelve weeks after initiation of combined therapy. Results are reported as the difference between baseline and 12 weeks after start of therapy.
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Androgen Deprivation and Cixutumumab) Arm II (Androgen Deprivation Therapy)
Hide Arm/Group Description:

Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.

Bicalutamide: Given PO

Cixutumumab: Given IV

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given IM

Pharmacological Study: Correlative studies

Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.

Bicalutamide: Given PO

Goserelin Acetate: Given SC

Laboratory Biomarker Analysis: Correlative studies

Leuprolide Acetate: Given IM

Pharmacological Study: Correlative studies

Overall Number of Participants Analyzed 18 9
Mean (Standard Deviation)
Unit of Measure: ulU/mL
0  (5.1) 0  (1.5)
Time Frame Up to 28 weeks
Adverse Event Reporting Description Participants were monitored for toxicity prior to each cycle or at more frequent intervals appropriate for that participant, as judged by the treating physician.
 
Arm/Group Title Arm I (Androgen Deprivation and Cixutumumab) Arm II (Androgen Deprivation Therapy)
Hide Arm/Group Description

Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.

Bicalutamide: Given PO Cixutumumab: Given IV Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given IM Pharmacological Study: Correlative studies

Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.

Bicalutamide: Given PO Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given IM Pharmacological Study: Correlative studies

All-Cause Mortality
Arm I (Androgen Deprivation and Cixutumumab) Arm II (Androgen Deprivation Therapy)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Androgen Deprivation and Cixutumumab) Arm II (Androgen Deprivation Therapy)
Affected / at Risk (%) Affected / at Risk (%)
Total   10/101 (9.90%)   4/104 (3.85%) 
Blood and lymphatic system disorders     
Anemia   1/101 (0.99%)  0/104 (0.00%) 
Cardiac disorders     
Left ventricular systolic dysfunction   1/101 (0.99%)  0/104 (0.00%) 
Gastrointestinal disorders     
Colonic obstruction   1/101 (0.99%)  0/104 (0.00%) 
Dry mouth   1/101 (0.99%)  0/104 (0.00%) 
Duodenal ulcer   1/101 (0.99%)  0/104 (0.00%) 
Dysphagia   1/101 (0.99%)  0/104 (0.00%) 
Gastric hemorrhage   1/101 (0.99%)  0/104 (0.00%) 
Mucositis oral   1/101 (0.99%)  0/104 (0.00%) 
Nausea   1/101 (0.99%)  0/104 (0.00%) 
Vomiting   2/101 (1.98%)  0/104 (0.00%) 
General disorders     
Death NOS   0/101 (0.00%)  2/104 (1.92%) 
Malaise   1/101 (0.99%)  0/104 (0.00%) 
Pain   1/101 (0.99%)  0/104 (0.00%) 
Infections and infestations     
Soft tissue infection   1/101 (0.99%)  0/104 (0.00%) 
Tooth infection   1/101 (0.99%)  0/104 (0.00%) 
Urinary tract infection   1/101 (0.99%)  0/104 (0.00%) 
Injury, poisoning and procedural complications     
Fracture   1/101 (0.99%)  0/104 (0.00%) 
Metabolism and nutrition disorders     
Hypercalcemia   1/101 (0.99%)  0/104 (0.00%) 
Hyperglycemia   1/101 (0.99%)  0/104 (0.00%) 
Hypocalcemia   1/101 (0.99%)  0/104 (0.00%) 
Musculoskeletal and connective tissue disorders     
Exostosis   1/101 (0.99%)  0/104 (0.00%) 
Nervous system disorders     
Cognitive disturbance   1/101 (0.99%)  0/104 (0.00%) 
Stroke   0/101 (0.00%)  1/104 (0.96%) 
Renal and urinary disorders     
Urinary tract obstruction   1/101 (0.99%)  0/104 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory failure   0/101 (0.00%)  1/104 (0.96%) 
Vascular disorders     
Thromboembolic event   1/101 (0.99%)  0/104 (0.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I (Androgen Deprivation and Cixutumumab) Arm II (Androgen Deprivation Therapy)
Affected / at Risk (%) Affected / at Risk (%)
Total   101/101 (100.00%)   94/104 (90.38%) 
Blood and lymphatic system disorders     
Anemia   39/101 (38.61%)  30/104 (28.85%) 
Ear and labyrinth disorders     
Tinnitus   6/101 (5.94%)  1/104 (0.96%) 
Eye disorders     
Blurred vision   11/101 (10.89%)  4/104 (3.85%) 
Flashing lights   8/101 (7.92%)  0/104 (0.00%) 
Gastrointestinal disorders     
Abdominal pain   11/101 (10.89%)  9/104 (8.65%) 
Constipation   17/101 (16.83%)  9/104 (8.65%) 
Diarrhea   24/101 (23.76%)  8/104 (7.69%) 
Dry mouth   10/101 (9.90%)  1/104 (0.96%) 
Nausea   16/101 (15.84%)  6/104 (5.77%) 
Oral pain   10/101 (9.90%)  0/104 (0.00%) 
Vomiting   7/101 (6.93%)  5/104 (4.81%) 
General disorders     
Chills   6/101 (5.94%)  3/104 (2.88%) 
Edema limbs   9/101 (8.91%)  8/104 (7.69%) 
Fatigue   66/101 (65.35%)  47/104 (45.19%) 
Flu like symptoms   9/101 (8.91%)  0/104 (0.00%) 
Pain   24/101 (23.76%)  21/104 (20.19%) 
Infections and infestations     
Urinary tract infection   6/101 (5.94%)  2/104 (1.92%) 
Injury, poisoning and procedural complications     
Bruising   10/101 (9.90%)  1/104 (0.96%) 
Investigations     
Alanine aminotransferase increased   19/101 (18.81%)  14/104 (13.46%) 
Alkaline phosphatase increased   10/101 (9.90%)  16/104 (15.38%) 
Aspartate aminotransferase increased   15/101 (14.85%)  14/104 (13.46%) 
Blood bilirubin increased   6/101 (5.94%)  3/104 (2.88%) 
Creatinine increased   24/101 (23.76%)  12/104 (11.54%) 
Lymphocyte count decreased   3/101 (2.97%)  10/104 (9.62%) 
Neutrophil count decreased   14/101 (13.86%)  4/104 (3.85%) 
Platelet count decreased   33/101 (32.67%)  5/104 (4.81%) 
Weight gain   4/101 (3.96%)  7/104 (6.73%) 
Weight loss   11/101 (10.89%)  2/104 (1.92%) 
White blood cell decreased   7/101 (6.93%)  9/104 (8.65%) 
Metabolism and nutrition disorders     
Anorexia   12/101 (11.88%)  8/104 (7.69%) 
Hypercalcemia   11/101 (10.89%)  4/104 (3.85%) 
Hyperglycemia   55/101 (54.46%)  25/104 (24.04%) 
Hyperkalemia   8/101 (7.92%)  5/104 (4.81%) 
Hypocalcemia   5/101 (4.95%)  6/104 (5.77%) 
Hypoglycemia   2/101 (1.98%)  6/104 (5.77%) 
Hypokalemia   3/101 (2.97%)  8/104 (7.69%) 
Hyponatremia   8/101 (7.92%)  7/104 (6.73%) 
Musculoskeletal and connective tissue disorders     
Arthralgia   18/101 (17.82%)  15/104 (14.42%) 
Arthritis   7/101 (6.93%)  3/104 (2.88%) 
Back pain   30/101 (29.70%)  20/104 (19.23%) 
Bone pain   13/101 (12.87%)  13/104 (12.50%) 
Flank pain   7/101 (6.93%)  5/104 (4.81%) 
Generalized muscle weakness   8/101 (7.92%)  3/104 (2.88%) 
Muscle weakness lower limb   6/101 (5.94%)  2/104 (1.92%) 
Myalgia   17/101 (16.83%)  7/104 (6.73%) 
Pain in extremity   14/101 (13.86%)  9/104 (8.65%) 
Nervous system disorders     
Dizziness   23/101 (22.77%)  9/104 (8.65%) 
Dysgeusia   13/101 (12.87%)  0/104 (0.00%) 
Headache   12/101 (11.88%)  4/104 (3.85%) 
Peripheral sensory neuropathy   9/101 (8.91%)  5/104 (4.81%) 
Psychiatric disorders     
Anxiety   8/101 (7.92%)  7/104 (6.73%) 
Depression   10/101 (9.90%)  7/104 (6.73%) 
Insomnia   8/101 (7.92%)  10/104 (9.62%) 
Libido decreased   3/101 (2.97%)  9/104 (8.65%) 
Renal and urinary disorders     
Hematuria   10/101 (9.90%)  6/104 (5.77%) 
Urinary frequency   24/101 (23.76%)  18/104 (17.31%) 
Urinary incontinence   11/101 (10.89%)  2/104 (1.92%) 
Urinary urgency   6/101 (5.94%)  4/104 (3.85%) 
Reproductive system and breast disorders     
Erectile dysfunction   5/101 (4.95%)  12/104 (11.54%) 
Pelvic pain   8/101 (7.92%)  3/104 (2.88%) 
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis   7/101 (6.93%)  2/104 (1.92%) 
Cough   6/101 (5.94%)  4/104 (3.85%) 
Dyspnea   4/101 (3.96%)  6/104 (5.77%) 
Skin and subcutaneous tissue disorders     
Dry skin   21/101 (20.79%)  2/104 (1.92%) 
Pruritus   11/101 (10.89%)  4/104 (3.85%) 
Rash maculo-papular   10/101 (9.90%)  3/104 (2.88%) 
Skin and subcutaneous tissue disorders - Other   9/101 (8.91%)  0/104 (0.00%) 
Vascular disorders     
Hot flashes   49/101 (48.51%)  69/104 (66.35%) 
Hypertension   27/101 (26.73%)  25/104 (24.04%) 
Indicates events were collected by systematic assessment
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: Evan Y. Yu, MD
Organization: Department of Medicine, Division of Oncology, University of Washington
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01120236     History of Changes
Other Study ID Numbers: NCI-2011-02003
NCI-2011-02003 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SWOG-S0925
CDR0000663832
S0925 ( Other Identifier: SWOG )
S0925 ( Other Identifier: CTEP )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: May 7, 2010
First Posted: May 10, 2010
Results First Submitted: April 18, 2016
Results First Posted: October 6, 2016
Last Update Posted: February 26, 2018