Trial Outcomes & Findings for Docetaxel and Prednisone With or Without Vaccine Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer (NCT NCT01145508)
NCT ID: NCT01145508
Last Updated: 2017-09-19
Results Overview
Overall survival is defined as the time from randomization to death or the date of last known alive.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Assessed every 3 months for 2 years, and then every 6 months for 3 years
Results posted on
2017-09-19
Participant Flow
Participants were recruited from Eastern Cooperative Oncology Group (ECOG) member institutions between December 29, 2010 and March 26, 2012.
Participant milestones
| Measure |
Arm A (Vaccine and Chemotherapy)
Patients receive vaccinia-PSA(L155)-TRICOM vaccine subcutaneously (SC) on day 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15, 29, 43, and 57. Beginning on day 85, patients receive chemotherapy in a 21-day cycle. Docetaxel is administered intravenously (IV) over 1 hour on day 1. Prednisone is given orally (PO) twice daily on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
PSA-TRICOM vaccine: Given SC
fowlpox-PSA-TRICOM vaccine: Given SC
docetaxel: Given IV
prednisone: Given PO
|
Arm B (Chemotherapy)
Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO twice daily on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
prednisone: Given PO
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
3
|
|
Overall Study
Treated
|
6
|
2
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Arm A (Vaccine and Chemotherapy)
Patients receive vaccinia-PSA(L155)-TRICOM vaccine subcutaneously (SC) on day 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15, 29, 43, and 57. Beginning on day 85, patients receive chemotherapy in a 21-day cycle. Docetaxel is administered intravenously (IV) over 1 hour on day 1. Prednisone is given orally (PO) twice daily on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
PSA-TRICOM vaccine: Given SC
fowlpox-PSA-TRICOM vaccine: Given SC
docetaxel: Given IV
prednisone: Given PO
|
Arm B (Chemotherapy)
Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO twice daily on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
prednisone: Given PO
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Never started treatment
|
1
|
1
|
Baseline Characteristics
Docetaxel and Prednisone With or Without Vaccine Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm A (Vaccine and Chemotherapy)
n=7 Participants
Patients receive vaccinia-PSA(L155)-TRICOM vaccine subcutaneously (SC) on day 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15, 29, 43, and 57. Beginning on day 85, patients receive chemotherapy in a 21-day cycle. Docetaxel is administered intravenously (IV) over 1 hour on day 1. Prednisone is given orally (PO) twice daily on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
PSA-TRICOM vaccine: Given SC
fowlpox-PSA-TRICOM vaccine: Given SC
docetaxel: Given IV
prednisone: Given PO
|
Arm B (Chemotherapy)
n=3 Participants
Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO twice daily on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
prednisone: Given PO
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
65 years
n=7 Participants
|
64 years
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
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed every 3 months for 2 years, and then every 6 months for 3 yearsPopulation: All randomized patients are included in the analysis.
Overall survival is defined as the time from randomization to death or the date of last known alive.
Outcome measures
| Measure |
Arm A (Vaccine and Chemotherapy)
n=7 Participants
Patients receive vaccinia-PSA(L155)-TRICOM vaccine subcutaneously (SC) on day 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15, 29, 43, and 57. Beginning on day 85, patients receive chemotherapy in a 21-day cycle. Docetaxel is administered intravenously (IV) over 1 hour on day 1. Prednisone is given orally (PO) twice daily on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
PSA-TRICOM vaccine: Given SC
fowlpox-PSA-TRICOM vaccine: Given SC
docetaxel: Given IV
prednisone: Given PO
|
Arm B (Chemotherapy)
n=3 Participants
Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO twice daily on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
prednisone: Given PO
|
|---|---|---|
|
Overall Survival
|
20.8 Months
Interval 3.4 to
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.
|
NA Months
Interval 14.8 to
The median was not reached and 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.
|
Adverse Events
Arm A (Vaccine and Chemotherapy)
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm B (Chemotherapy)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (Vaccine and Chemotherapy)
n=6 participants at risk
Patients receive vaccinia-PSA(L155)-TRICOM vaccine subcutaneously (SC) on day 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15, 29, 43, and 57. Beginning on day 85, patients receive chemotherapy in a 21-day cycle. Docetaxel is administered intravenously (IV) over 1 hour on day 1. Prednisone is given orally (PO) twice daily on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
PSA-TRICOM vaccine: Given SC
fowlpox-PSA-TRICOM vaccine: Given SC
docetaxel: Given IV
prednisone: Given PO
|
Arm B (Chemotherapy)
n=2 participants at risk
Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO twice daily on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
prednisone: Given PO
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
1/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
16.7%
1/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Sepsis
|
16.7%
1/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphocyte count decreased
|
16.7%
1/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophil count decreased
|
66.7%
4/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
100.0%
2/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
White blood cell decreased
|
50.0%
3/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Syncope
|
16.7%
1/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Thromboembolic event
|
16.7%
1/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
Other adverse events
| Measure |
Arm A (Vaccine and Chemotherapy)
n=6 participants at risk
Patients receive vaccinia-PSA(L155)-TRICOM vaccine subcutaneously (SC) on day 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15, 29, 43, and 57. Beginning on day 85, patients receive chemotherapy in a 21-day cycle. Docetaxel is administered intravenously (IV) over 1 hour on day 1. Prednisone is given orally (PO) twice daily on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
PSA-TRICOM vaccine: Given SC
fowlpox-PSA-TRICOM vaccine: Given SC
docetaxel: Given IV
prednisone: Given PO
|
Arm B (Chemotherapy)
n=2 participants at risk
Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO twice daily on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
docetaxel: Given IV
prednisone: Given PO
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
2/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Chills
|
16.7%
1/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Edema face
|
16.7%
1/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Edema limbs
|
50.0%
3/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
83.3%
5/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
100.0%
2/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fever
|
16.7%
1/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Injection site reaction
|
16.7%
1/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
66.7%
4/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
100.0%
2/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.7%
1/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
33.3%
2/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
16.7%
1/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
16.7%
1/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue - Other
|
33.3%
2/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
4/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
2/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
2/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
0.00%
0/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Nail infection
|
0.00%
0/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Paronychia
|
16.7%
1/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Injury, poisoning and procedural complications
Bruising
|
16.7%
1/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Creatinine increased
|
0.00%
0/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphocyte count decreased
|
33.3%
2/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
White blood cell decreased
|
33.3%
2/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
2/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
2/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Dysgeusia
|
50.0%
3/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
100.0%
2/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
66.7%
4/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Eye disorders
Watering eyes
|
0.00%
0/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
50.0%
1/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
16.7%
1/6 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/2 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
Additional Information
Study Statistician
ECOG Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60