Trial Outcomes & Findings for S0032, Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer (NCT NCT00028769)
NCT ID: NCT00028769
Last Updated: 2013-07-16
Results Overview
Measured from time of registration to time of first documentation of progression determined from the prostate-specific antigen (PSA) level, clinical criteria, or symptomatic deterioration. PSA progression is defined as a 25% increase greater than baseline. If the patient's PSA level had decrease during the study, a 25% increase from the nadir PSA level, with absolute value of \>=5 ng/mL is considered progression. CLinical progress is defined as the appearance of any new lesion at any site or death without documented progression. Symptomatic deterioration is defined as a global deterioration of the health status requiring discontinuation of treatment without objective evidence of progression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
0-5 years (assessed every 3 months if no progression when the chemotherapy had been finished. Once off chemotherapy, assessed every 3 months until progression)
Results posted on
2013-07-16
Participant Flow
Participant milestones
| Measure |
CAD + Chemo
Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m\^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m\^2 given intravenously within 1 hour on day 2 of each cycle)
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
Eligible
|
36
|
|
Overall Study
Eligible and Began Protocol Therapy
|
35
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
41
|
Reasons for withdrawal
| Measure |
CAD + Chemo
Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m\^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m\^2 given intravenously within 1 hour on day 2 of each cycle)
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Refusal Unrelated to Adverse Events
|
1
|
|
Overall Study
Progression or Death
|
31
|
|
Overall Study
Other - Not Protocol Specified
|
1
|
|
Overall Study
Ineligible
|
5
|
|
Overall Study
Not Analyzable
|
1
|
Baseline Characteristics
S0032, Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
CAD + Chemo
n=35 Participants
Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m\^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m\^2 given intravenously within 1 hour on day 2 of each cycle)
|
|---|---|
|
Age Continuous
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Southwestern Oncology Group Performance Status
0
|
20 participants
n=5 Participants
|
|
Southwestern Oncology Group Performance Status
1
|
15 participants
n=5 Participants
|
|
Bone Pain Grade (CTC version 2.0)
Missing
|
2 participants
n=5 Participants
|
|
Bone Pain Grade (CTC version 2.0)
<2
|
26 participants
n=5 Participants
|
|
Bone Pain Grade (CTC version 2.0)
>=2
|
7 participants
n=5 Participants
|
|
Previous Prostatectomy
Yes
|
6 participants
n=5 Participants
|
|
Previous Prostatectomy
No/Unknown
|
29 participants
n=5 Participants
|
|
Gleason Score
Missing
|
1 participants
n=5 Participants
|
|
Gleason Score
6
|
2 participants
n=5 Participants
|
|
Gleason Score
7
|
12 participants
n=5 Participants
|
|
Gleason Score
8
|
6 participants
n=5 Participants
|
|
Gleason Score
9-10
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-5 years (assessed every 3 months if no progression when the chemotherapy had been finished. Once off chemotherapy, assessed every 3 months until progression)Population: All eligible patients who started treatment were included in the analysis
Measured from time of registration to time of first documentation of progression determined from the prostate-specific antigen (PSA) level, clinical criteria, or symptomatic deterioration. PSA progression is defined as a 25% increase greater than baseline. If the patient's PSA level had decrease during the study, a 25% increase from the nadir PSA level, with absolute value of \>=5 ng/mL is considered progression. CLinical progress is defined as the appearance of any new lesion at any site or death without documented progression. Symptomatic deterioration is defined as a global deterioration of the health status requiring discontinuation of treatment without objective evidence of progression.
Outcome measures
| Measure |
CAD + Chemo
n=35 Participants
Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m\^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m\^2 given intravenously within 1 hour on day 2 of each cycle)
|
|---|---|
|
Progression-free Survival
|
13 months
Interval 10.0 to 16.0
|
PRIMARY outcome
Timeframe: 0-5 yearsPopulation: All eligible patients who started treatment were included in the analysis
Overall survival is defined from the date of registration to date of death from any cause
Outcome measures
| Measure |
CAD + Chemo
n=35 Participants
Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m\^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m\^2 given intravenously within 1 hour on day 2 of each cycle)
|
|---|---|
|
Overall Survival (OS)
|
38 months
Interval 28.0 to 49.0
|
SECONDARY outcome
Timeframe: up to 5 years after registrationPopulation: Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 2.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
Outcome measures
| Measure |
CAD + Chemo
n=35 Participants
Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m\^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m\^2 given intravenously within 1 hour on day 2 of each cycle)
|
|---|---|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Alkaline phosphatase increase
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Anemia
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Bilirubin increase
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Cardiac ischemia/infarction
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Confusion
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Constipation/bowel obstruction
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Edema
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Erectile impotence
|
3 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Fatigue/malaise/lethargy
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
GI-other
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Hyperglycemia
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Infection w/o 3-4 neutropenia
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Infection with 3-4 neutropenia
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Leukopenia
|
9 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Lymphopenia
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Neutropenia/granulocytopenia
|
9 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
PRBC transfusion
|
2 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Pain-other
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Prothrombin time increase
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Renal failure
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Second primary
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Thrombocytopenia
|
1 Participants
|
|
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Thrombosis/embolism
|
4 Participants
|
Adverse Events
CAD + Chemo
Serious events: 6 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CAD + Chemo
n=35 participants at risk
Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m\^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m\^2 given intravenously within 1 hour on day 2 of each cycle)
|
|---|---|
|
Cardiac disorders
Cardiac ischemia/infarction
|
5.7%
2/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
General disorders
Flu-like symptoms-other
|
2.9%
1/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Infections and infestations
Infection with 3-4 neutropenia
|
2.9%
1/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Investigations
Abnormal troponin I (cTnI)
|
2.9%
1/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Investigations
Leukopenia
|
2.9%
1/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second primary
|
2.9%
1/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Vascular disorders
Thrombosis/embolism
|
5.7%
2/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
Other adverse events
| Measure |
CAD + Chemo
n=35 participants at risk
Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m\^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m\^2 given intravenously within 1 hour on day 2 of each cycle)
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
51.4%
18/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Blood and lymphatic system disorders
PRBC transfusion
|
5.7%
2/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Gastrointestinal disorders
Abdominal pain/cramping
|
5.7%
2/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Gastrointestinal disorders
Constipation/bowel obstruction
|
17.1%
6/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Gastrointestinal disorders
Diarrhea without colostomy
|
22.9%
8/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
8.6%
3/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Gastrointestinal disorders
Esophagitis/dysphagia
|
8.6%
3/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Gastrointestinal disorders
GI-other
|
8.6%
3/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Gastrointestinal disorders
Nausea
|
57.1%
20/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Gastrointestinal disorders
Proctitis
|
11.4%
4/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis
|
14.3%
5/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Gastrointestinal disorders
Vomiting
|
25.7%
9/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
General disorders
Edema
|
34.3%
12/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
General disorders
Fatigue/malaise/lethargy
|
85.7%
30/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
General disorders
Fever without neutropenia
|
8.6%
3/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
General disorders
Pain-other
|
42.9%
15/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Infections and infestations
Infection w/o 3-4 neutropenia
|
8.6%
3/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Infections and infestations
Respiratory infect w/o neutrop
|
8.6%
3/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Investigations
Alkaline phosphatase increase
|
14.3%
5/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Investigations
Bilirubin increase
|
11.4%
4/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Investigations
Creatinine increase
|
5.7%
2/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Investigations
Leukopenia
|
60.0%
21/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Investigations
Lymphopenia
|
11.4%
4/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Investigations
Neutropenia/granulocytopenia
|
37.1%
13/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Investigations
SGOT (AST) increase
|
31.4%
11/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Investigations
SGPT (ALT) increase
|
8.6%
3/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Investigations
Thrombocytopenia
|
8.6%
3/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Investigations
Weight gain
|
11.4%
4/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Investigations
Weight loss
|
8.6%
3/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
17.1%
6/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
28.6%
10/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.6%
3/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
17.1%
6/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.7%
2/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.4%
4/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.7%
2/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
2/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
11.4%
4/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Joint,muscle,bone-other
|
8.6%
3/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.1%
6/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia/arthralgia, NOS
|
5.7%
2/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Nervous system disorders
Dizziness/light headedness
|
8.6%
3/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Nervous system disorders
Headache
|
14.3%
5/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Nervous system disorders
Sensory neuropathy
|
22.9%
8/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Nervous system disorders
Weakness (motor neuropathy)
|
11.4%
4/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Psychiatric disorders
Confusion
|
5.7%
2/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Psychiatric disorders
Depression
|
8.6%
3/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Psychiatric disorders
Insomnia
|
22.9%
8/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Renal and urinary disorders
Dysuria
|
8.6%
3/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Renal and urinary disorders
Hematuria
|
14.3%
5/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Renal and urinary disorders
Incontinence
|
8.6%
3/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
14.3%
5/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Renal and urinary disorders
Urinary retention
|
8.6%
3/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Reproductive system and breast disorders
Erectile impotence
|
22.9%
8/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Reproductive system and breast disorders
Gynecomastia
|
17.1%
6/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Reproductive system and breast disorders
Libido loss
|
5.7%
2/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
7/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.1%
6/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
5.7%
2/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
51.4%
18/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
5.7%
2/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.6%
3/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
14.3%
5/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
8.6%
3/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Vascular disorders
Hot flashes
|
25.7%
9/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Vascular disorders
Hypertension
|
5.7%
2/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
|
Vascular disorders
Thrombosis/embolism
|
8.6%
3/35 • Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment
|
Additional Information
Study Statistician
SWOG Statistical Center
Phone: 206-667-4623
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place