Trial Outcomes & Findings for Docetaxel and Prednisone With or Without Cediranib in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy (NCT NCT00527124)
NCT ID: NCT00527124
Last Updated: 2018-08-09
Results Overview
The proportion of patients on each treatment arm who survive ≥ 6.00 months progression-free
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
Followed for 52 weeks at 3 month intervals after coming off treatment, time period equal to the length of treatment + up to 12 months
Results posted on
2018-08-09
Participant Flow
Subjects were recruited from the outpatient clinics or inpatient service of Karmanos Cancer Center by physicians in the Department of Hematology and Medical Oncology, between December 2007 and December 2011.
57 subjects went on study; an additional 27 subjects were consented, 23 were not eligible to go on study, 4 withdrew from study.
Participant milestones
| Measure |
Arm I
Patients receive oral cediranib once daily on days 1-21, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21.
|
Arm II
Patients receive docetaxel and prednisone as in arm I.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
28
|
|
Overall Study
COMPLETED
|
29
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Docetaxel and Prednisone With or Without Cediranib in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
Baseline characteristics by cohort
| Measure |
Arm I
n=29 Participants
Patients receive oral cediranib once daily on days 1-21, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21.
|
Arm II
n=28 Participants
Patients receive docetaxel and prednisone as in arm I.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.14 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
68.29 years
STANDARD_DEVIATION 9.66 • n=7 Participants
|
68.72 years
STANDARD_DEVIATION 8.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
28 participants
n=7 Participants
|
57 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Followed for 52 weeks at 3 month intervals after coming off treatment, time period equal to the length of treatment + up to 12 monthsPopulation: Per protocol. 30 subjects on Arm I and 28 subjects on Arm II accrued for analysis of the primary endpoint of 6 mths PFS proportion. PFS is obtainable on all 58 participants enrolled, however 1 subject enrolled on Arm I withdrew before receiving any treatment, hence cannot be included for AE analysis and reporting, AE results involve 29 subjects.
The proportion of patients on each treatment arm who survive ≥ 6.00 months progression-free
Outcome measures
| Measure |
Arm I
n=30 Participants
Patients receive oral cediranib 20 mg once daily on days 1-21, docetaxel 75mg/m2 IV over 1 hour on day 1 every 3 weeks, and oral prednisone 5mg twice daily on days 1-21.
|
Arm II
n=28 Participants
Patients receive docetaxel 75 mg/m2 IV every 3 weeks, and prednisone 5mg orally twice a day, Repeat cycle every 21 days.
|
|---|---|---|
|
6-month Progression-free Survival (PFS) Proportion
|
60 percentage of patients
Interval 42.0 to 75.0
|
54 percentage of patients
Interval 36.0 to 71.0
|
SECONDARY outcome
Timeframe: Up to 52 weeksPSA \< 4.0 ng/ml. is a CR. A 50% decline or better in PSA is a PR. Less than a 50% decline in PSA and less than a 25% increase in PSA is SD. A 25% or greater increase in PSA level by at least 5 ng/mL is PD by PSA only. The point estimate and 95% Wilson CI estimates of the proportion for the Prostate-specific antigen (PSA) response will be computed .
Outcome measures
| Measure |
Arm I
n=30 Participants
Patients receive oral cediranib 20 mg once daily on days 1-21, docetaxel 75mg/m2 IV over 1 hour on day 1 every 3 weeks, and oral prednisone 5mg twice daily on days 1-21.
|
Arm II
n=28 Participants
Patients receive docetaxel 75 mg/m2 IV every 3 weeks, and prednisone 5mg orally twice a day, Repeat cycle every 21 days.
|
|---|---|---|
|
Prostate-specific Antigen (PSA) Response in Accordance With the Prostate Specific Antigen Working Group
CR
|
.35 proportion of evaluable patients
Interval 0.19 to 0.54
|
.12 proportion of evaluable patients
Interval 0.04 to 0.29
|
|
Prostate-specific Antigen (PSA) Response in Accordance With the Prostate Specific Antigen Working Group
PR
|
.27 proportion of evaluable patients
Interval 0.14 to 0.46
|
.54 proportion of evaluable patients
Interval 0.35 to 0.71
|
|
Prostate-specific Antigen (PSA) Response in Accordance With the Prostate Specific Antigen Working Group
SD
|
.35 proportion of evaluable patients
Interval 0.19 to 0.54
|
.31 proportion of evaluable patients
Interval 0.17 to 0.5
|
|
Prostate-specific Antigen (PSA) Response in Accordance With the Prostate Specific Antigen Working Group
PD
|
.04 proportion of evaluable patients
Interval 0.01 to 0.19
|
.04 proportion of evaluable patients
Interval 0.01 to 0.19
|
SECONDARY outcome
Timeframe: Up to 52 weeksThe overall response is determined by combining the patient's status on target lesions, PSA, non-target lesions, and new disease as defined in the following table. Target Lesions CR CR PR SD PD Any Any Any PSA Response CR PR PR Non-PD Any Any PD Any Non-Target Lesions CR Non-CR/Non-PD Non-PD Non-PD Any PD Any Any New Lesions No No No No Yes or No Yes or No Yes or No Yes Overall Response CR PR PR SD PD PD PD PD
Outcome measures
| Measure |
Arm I
n=30 Participants
Patients receive oral cediranib 20 mg once daily on days 1-21, docetaxel 75mg/m2 IV over 1 hour on day 1 every 3 weeks, and oral prednisone 5mg twice daily on days 1-21.
|
Arm II
n=28 Participants
Patients receive docetaxel 75 mg/m2 IV every 3 weeks, and prednisone 5mg orally twice a day, Repeat cycle every 21 days.
|
|---|---|---|
|
Overall Response Rate Evaluated by the RECIST Criteria
SD
|
.92 proportion of evaluable patients
Interval 0.75 to 0.98
|
.92 proportion of evaluable patients
Interval 0.76 to 0.98
|
|
Overall Response Rate Evaluated by the RECIST Criteria
PD
|
.08 proportion of evaluable patients
Interval 0.02 to 0.25
|
.08 proportion of evaluable patients
Interval 0.02 to 0.24
|
SECONDARY outcome
Timeframe: The time from registration date until documented clinical disease progression, or until date of death, whichever occurs first, assessed up to 52 weeksAnalyzed with standard K-M methodology. Both point and 95% CI estimates of the median and other statistics (e.g., the 3-month rate, 6-month rate, etc.) will be computed from the censored distribution of TTP. These point and CI estimates will be reported for all patients combined, and separately for each treatment arm.
Outcome measures
| Measure |
Arm I
n=30 Participants
Patients receive oral cediranib 20 mg once daily on days 1-21, docetaxel 75mg/m2 IV over 1 hour on day 1 every 3 weeks, and oral prednisone 5mg twice daily on days 1-21.
|
Arm II
n=28 Participants
Patients receive docetaxel 75 mg/m2 IV every 3 weeks, and prednisone 5mg orally twice a day, Repeat cycle every 21 days.
|
|---|---|---|
|
Time to Progression
|
8.0 months
Interval 4.2 to 11.9
|
6.4 months
Interval 4.8 to 10.2
|
SECONDARY outcome
Timeframe: The time from registration date until death from any cause, assessed up to 52 weeksAnalyzed with standard K-M methodology. A 12 month survival rate will be calculated since median survival was not reached by the end of the study period.
Outcome measures
| Measure |
Arm I
n=30 Participants
Patients receive oral cediranib 20 mg once daily on days 1-21, docetaxel 75mg/m2 IV over 1 hour on day 1 every 3 weeks, and oral prednisone 5mg twice daily on days 1-21.
|
Arm II
n=28 Participants
Patients receive docetaxel 75 mg/m2 IV every 3 weeks, and prednisone 5mg orally twice a day, Repeat cycle every 21 days.
|
|---|---|---|
|
Overall Survival
|
71 percentage of patients
Interval 51.0 to 84.0
|
76 percentage of patients
Interval 55.0 to 88.0
|
Adverse Events
Arm I
Serious events: 20 serious events
Other events: 29 other events
Deaths: 0 deaths
Arm II
Serious events: 9 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I
n=29 participants at risk
Patients receive oral cediranib once daily on days 1-21, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21.
|
Arm II
n=28 participants at risk
Patients receive docetaxel and prednisone as in arm I.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
6.9%
2/29 • Number of events 2
|
0.00%
0/28
|
|
Blood and lymphatic system disorders
Febrile netropenia
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Cardiac disorders
Atrial fibrillation
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Cardiac disorders
Cardiopulmonary arrest
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/29
|
3.6%
1/28 • Number of events 1
|
|
Cardiac disorders
Chest pain-cardiac
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Eye disorders
Watering eyes
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Gastrointestinal disorders
Abdominal pain
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Gastrointestinal disorders
Diarrhea
|
6.9%
2/29 • Number of events 2
|
0.00%
0/28
|
|
Gastrointestinal disorders
Dyspepsia
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Gastrointestinal disorders
Mucositis
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
6.9%
2/29 • Number of events 2
|
0.00%
0/28
|
|
Gastrointestinal disorders
Vomiting
|
6.9%
2/29 • Number of events 2
|
0.00%
0/28
|
|
General disorders
Chills
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
General disorders
Death NOS
|
0.00%
0/29
|
3.6%
1/28 • Number of events 1
|
|
General disorders
Edema limbs
|
6.9%
2/29 • Number of events 2
|
0.00%
0/28
|
|
General disorders
Fatigue
|
10.3%
3/29 • Number of events 3
|
0.00%
0/28
|
|
General disorders
Fever
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
General disorders
Non-cardiac chest pain
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/29
|
3.6%
1/28 • Number of events 1
|
|
Infections and infestations
Enterocolitis infectious
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Infections and infestations
Infection with Grade 3 or 4 Neutrophils (ANC <1.0 X 10E9/L): Bronchus
|
0.00%
0/29
|
3.6%
1/28 • Number of events 1
|
|
Infections and infestations
Infection with Grade 3 or 4 Neutrophils (ANC <1.0 X 10E9/L): Lung
|
0.00%
0/29
|
3.6%
1/28 • Number of events 1
|
|
Infections and infestations
Mucosal infection
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Infections and infestations
Skin infection
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Infections and infestations
Urinary Tract Infection
|
3.4%
1/29 • Number of events 1
|
3.6%
1/28 • Number of events 1
|
|
Infections and infestations
Wound infection
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Investigations
Alanine aminotransferase increased
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/29
|
3.6%
1/28 • Number of events 1
|
|
Investigations
Creatinine increased
|
6.9%
2/29 • Number of events 2
|
0.00%
0/28
|
|
Investigations
INR increased
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Investigations
Lymphocyte count decreased
|
17.2%
5/29 • Number of events 5
|
3.6%
1/28 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
41.4%
12/29 • Number of events 12
|
10.7%
3/28 • Number of events 3
|
|
Investigations
Platelet count decreased
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Investigations
White blood cell decreased
|
37.9%
11/29 • Number of events 11
|
0.00%
0/28
|
|
Metabolism and nutrition disorders
Anorexia
|
10.3%
3/29 • Number of events 3
|
0.00%
0/28
|
|
Metabolism and nutrition disorders
Dehydration
|
6.9%
2/29 • Number of events 2
|
0.00%
0/28
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.9%
2/29 • Number of events 2
|
0.00%
0/28
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.3%
3/29 • Number of events 3
|
0.00%
0/28
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/29
|
3.6%
1/28 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.3%
3/29 • Number of events 3
|
0.00%
0/28
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.9%
2/29 • Number of events 2
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/29
|
3.6%
1/28 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.3%
3/29 • Number of events 3
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Nervous system disorders
Depressed level of consciousness
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Nervous system disorders
Dysphasia
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/29
|
3.6%
1/28 • Number of events 1
|
|
Nervous system disorders
Memory impairment
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Renal and urinary disorders
Proteinuria
|
17.2%
5/29 • Number of events 5
|
0.00%
0/28
|
|
Renal and urinary disorders
Urinary incontinence
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Renal and urinary disorders
Urinary tract obstruction
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.9%
2/29 • Number of events 2
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.4%
1/29 • Number of events 1
|
0.00%
0/28
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.9%
2/29 • Number of events 2
|
0.00%
0/28
|
|
Vascular disorders
Hypotension
|
10.3%
3/29 • Number of events 3
|
0.00%
0/28
|
|
Vascular disorders
Thromboembolic event
|
6.9%
2/29 • Number of events 2
|
0.00%
0/28
|
Other adverse events
| Measure |
Arm I
n=29 participants at risk
Patients receive oral cediranib once daily on days 1-21, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21.
|
Arm II
n=28 participants at risk
Patients receive docetaxel and prednisone as in arm I.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
55.2%
16/29 • Number of events 16
|
57.1%
16/28 • Number of events 16
|
|
Cardiac disorders
Chest pain- cardiac
|
0.00%
0/29
|
7.1%
2/28 • Number of events 2
|
|
Eye disorders
Watering eyes
|
17.2%
5/29 • Number of events 5
|
10.7%
3/28 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain
|
13.8%
4/29 • Number of events 4
|
0.00%
0/28
|
|
Gastrointestinal disorders
Diarrhea
|
20.7%
6/29 • Number of events 6
|
89.3%
25/28 • Number of events 25
|
|
Gastrointestinal disorders
Dyspepsia
|
6.9%
2/29 • Number of events 2
|
10.7%
3/28 • Number of events 3
|
|
Gastrointestinal disorders
Mucositis oral
|
6.9%
2/29 • Number of events 2
|
35.7%
10/28 • Number of events 10
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/29
|
7.1%
2/28 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
6.9%
2/29 • Number of events 2
|
21.4%
6/28 • Number of events 6
|
|
General disorders
Edema limbs
|
27.6%
8/29 • Number of events 8
|
17.9%
5/28 • Number of events 5
|
|
General disorders
Fatigue
|
51.7%
15/29 • Number of events 15
|
82.1%
23/28 • Number of events 23
|
|
Gastrointestinal disorders
Fever
|
6.9%
2/29 • Number of events 2
|
0.00%
0/28
|
|
Infections and infestations
Urinary tract infection
|
6.9%
2/29 • Number of events 2
|
7.1%
2/28 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
13.8%
4/29 • Number of events 4
|
32.1%
9/28 • Number of events 9
|
|
Investigations
Creatinine increased
|
13.8%
4/29 • Number of events 4
|
17.9%
5/28 • Number of events 5
|
|
Investigations
INR increased
|
0.00%
0/29
|
7.1%
2/28 • Number of events 2
|
|
Investigations
Lymphocyte count decreased
|
44.8%
13/29 • Number of events 13
|
57.1%
16/28 • Number of events 16
|
|
Investigations
Neutrophil count decreased
|
44.8%
13/29 • Number of events 13
|
32.1%
9/28 • Number of events 9
|
|
Investigations
Platelet count decreased
|
27.6%
8/29 • Number of events 8
|
53.6%
15/28 • Number of events 15
|
|
Investigations
White blood cell decreased
|
37.9%
11/29 • Number of events 11
|
39.3%
11/28 • Number of events 11
|
|
Metabolism and nutrition disorders
Anorexia
|
17.2%
5/29 • Number of events 5
|
42.9%
12/28 • Number of events 12
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/29
|
14.3%
4/28 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
41.4%
12/29 • Number of events 12
|
53.6%
15/28 • Number of events 15
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
44.8%
13/29 • Number of events 13
|
53.6%
15/28 • Number of events 15
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.7%
6/29 • Number of events 6
|
46.4%
13/28 • Number of events 13
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
10.3%
3/29 • Number of events 3
|
10.7%
3/28 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyponatremia
|
17.2%
5/29 • Number of events 5
|
39.3%
11/28 • Number of events 11
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
17.2%
5/29 • Number of events 5
|
21.4%
6/28 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.3%
3/29 • Number of events 3
|
17.9%
5/28 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.3%
3/29 • Number of events 3
|
7.1%
2/28 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
6.9%
2/29 • Number of events 2
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.8%
4/29 • Number of events 4
|
25.0%
7/28 • Number of events 7
|
|
Renal and urinary disorders
Proteinuria
|
6.9%
2/29 • Number of events 2
|
39.3%
11/28 • Number of events 11
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/29
|
7.1%
2/28 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.8%
4/29 • Number of events 4
|
35.7%
10/28 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.9%
2/29 • Number of events 2
|
35.7%
10/28 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/29
|
35.7%
10/28 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/29
|
7.1%
2/28 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/29
|
14.3%
4/28 • Number of events 4
|
|
Vascular disorders
Hypotension
|
0.00%
0/29
|
10.7%
3/28 • Number of events 3
|
Additional Information
Elisabeth I. Heath
Barbara Ann Karmanos Cancer Institute
Phone: 313-576-8715
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60