Trial Outcomes & Findings for Pazopanib Hydrochloride After Leuprolide Acetate or Goserelin Acetate in Treating Patients With Relapsed Prostate Cancer (NCT NCT00454571)
NCT ID: NCT00454571
Last Updated: 2016-02-10
Results Overview
The median time to disease progression for the therapy and observation groups will be estimated using the Kaplan-Meier estimate and compared using the log-rank test.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
Baseline, every 4 weeks during treatment, and up to 12 months after completion of study treatment
Results posted on
2016-02-10
Participant Flow
Participant milestones
| Measure |
Pazopanib, Leuprolide Acetate, and Goserelin Acetate
Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
leuprolide acetate
goserelin acetate
|
Leuprolide Acetate and Goserelin Acetate Only
Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.
leuprolide acetate
goserelin acetate
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
19
|
|
Overall Study
COMPLETED
|
5
|
13
|
|
Overall Study
NOT COMPLETED
|
13
|
6
|
Reasons for withdrawal
| Measure |
Pazopanib, Leuprolide Acetate, and Goserelin Acetate
Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
leuprolide acetate
goserelin acetate
|
Leuprolide Acetate and Goserelin Acetate Only
Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.
leuprolide acetate
goserelin acetate
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
10
|
5
|
Baseline Characteristics
Pazopanib Hydrochloride After Leuprolide Acetate or Goserelin Acetate in Treating Patients With Relapsed Prostate Cancer
Baseline characteristics by cohort
| Measure |
Pazopanib, Leuprolide Acetate, and Goserelin Acetate
n=18 Participants
Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
leuprolide acetate
goserelin acetate
|
Leuprolide Acetate and Goserelin Acetate Only
n=19 Participants
Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.
leuprolide acetate
goserelin acetate
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74 years
n=5 Participants
|
71 years
n=7 Participants
|
72 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
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, every 4 weeks during treatment, and up to 12 months after completion of study treatmentPopulation: Patients were taken off study early, so many survival times were censored. At no point during the study did the proportion of subjects who progressed drop to 50%. Thus, it was not possible to calculate median time to disease progression.
The median time to disease progression for the therapy and observation groups will be estimated using the Kaplan-Meier estimate and compared using the log-rank test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from randomization to PSA progression or death from any causePopulation: Patients were taken off study early, so many survival times were censored. At no point during the study did the proportion of subjects who progressed drop to 50%. Thus, it was not possible to calculate median time to PSA progression.
Kaplan-Meier estimates for PSA progression-free survival will be computed for the pazopanib and active surveillance groups and compared using the log rank test. The outcome measure is median PSA progression-free survival time.
Outcome measures
Outcome data not reported
Adverse Events
Pazopanib, Leuprolide Acetate, and Goserelin Acetate
Serious events: 5 serious events
Other events: 16 other events
Deaths: 0 deaths
Leuprolide Acetate and Goserelin Acetate Only
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pazopanib, Leuprolide Acetate, and Goserelin Acetate
n=18 participants at risk
Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
leuprolide acetate
goserelin acetate
|
Leuprolide Acetate and Goserelin Acetate Only
n=19 participants at risk
Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.
leuprolide acetate
goserelin acetate
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Vascular disorders
Hypertension
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Cardiac disorders
Chest pain - cardiac
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Vascular disorders
Thromboembolic event
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
Other adverse events
| Measure |
Pazopanib, Leuprolide Acetate, and Goserelin Acetate
n=18 participants at risk
Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
pazopanib hydrochloride: Given PO
leuprolide acetate
goserelin acetate
|
Leuprolide Acetate and Goserelin Acetate Only
n=19 participants at risk
Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.
leuprolide acetate
goserelin acetate
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
22.2%
4/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Ear and labyrinth disorders
Tinnitus
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Eye disorders
Blurred vision
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Eye disorders
Eye disorders - Other
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
2/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
11.1%
2/18 • 1 year
|
5.3%
1/19 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
12/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
3/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Gastrointestinal disorders
Esophagitis
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Gastrointestinal disorders
Flatulence
|
11.1%
2/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Gastrointestinal disorders
Mucositis oral
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
16.7%
3/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Gastrointestinal disorders
Oral pain
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Gastrointestinal disorders
Stomach pain
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
General disorders
Edema face
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
General disorders
Fatigue
|
50.0%
9/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
General disorders
Pain
|
16.7%
3/18 • 1 year
|
5.3%
1/19 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
38.9%
7/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Investigations
Alkaline phosphatase increased
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
44.4%
8/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Investigations
Blood bilirubin increased
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Investigations
Creatinine increased
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
11.1%
2/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Investigations
Platelet count decreased
|
16.7%
3/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Investigations
Weight gain
|
0.00%
0/18 • 1 year
|
5.3%
1/19 • 1 year
|
|
Investigations
Weight loss
|
16.7%
3/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Investigations
White blood cell decreased
|
11.1%
2/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
22.2%
4/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
22.2%
4/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
3/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.1%
2/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.1%
2/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/18 • 1 year
|
5.3%
1/19 • 1 year
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Nervous system disorders
Dysgeusia
|
16.7%
3/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Nervous system disorders
Headache
|
22.2%
4/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Nervous system disorders
Memory impairment
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Nervous system disorders
Nervous system disorders - Other
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Psychiatric disorders
Anxiety
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/18 • 1 year
|
5.3%
1/19 • 1 year
|
|
Renal and urinary disorders
Proteinuria
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Renal and urinary disorders
Urinary frequency
|
11.1%
2/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Renal and urinary disorders
Urinary incontinence
|
11.1%
2/18 • 1 year
|
5.3%
1/19 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.2%
4/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
3/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
16.7%
3/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Vascular disorders
Hot flashes
|
16.7%
3/18 • 1 year
|
5.3%
1/19 • 1 year
|
|
Vascular disorders
Hypertension
|
50.0%
9/18 • 1 year
|
0.00%
0/19 • 1 year
|
|
Vascular disorders
Hypotension
|
5.6%
1/18 • 1 year
|
0.00%
0/19 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60