Trial Outcomes & Findings for Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer (NCT NCT00587431)
NCT ID: NCT00587431
Last Updated: 2023-11-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
Conclusion of the study (at 6 months then at 18 months post-treatment)
Results posted on
2023-11-07
Participant Flow
Protocol Open to Accrual: 07/08/2003 Protocol Closed to Accrual: 02/28/2006 Primary Completion Date: 02/26/2008 Recruitment Location is the Medical Clinic
Participant milestones
| Measure |
Lupron and Docetaxel (75mg/m2) and Testosterone for 7 Days
GnRh (Leuprolide): Leuprolide LUPRON
Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle
Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days
|
Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 Days
GnRh (Leuprolide): Leuprolide LUPRON
Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle
Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
39
|
|
Overall Study
COMPLETED
|
62
|
38
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Lupron and Docetaxel (75mg/m2) and Testosterone for 7 Days
GnRh (Leuprolide): Leuprolide LUPRON
Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle
Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days
|
Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 Days
GnRh (Leuprolide): Leuprolide LUPRON
Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle
Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer
Baseline characteristics by cohort
| Measure |
Lupron and Docetaxel (75mg/m2) and Testosterone for 7 Days
n=63 Participants
GnRh (Leuprolide): Leuprolide LUPRON
Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle
Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days
|
Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 Days
n=39 Participants
GnRh (Leuprolide): Leuprolide LUPRON
Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle
Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 25.45584412 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 26.1629509 • n=7 Participants
|
61.5 years
STANDARD_DEVIATION 30.40559159 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
33 Participants
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
|
63 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
63 participants
n=5 Participants
|
39 participants
n=7 Participants
|
102 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Conclusion of the study (at 6 months then at 18 months post-treatment)Outcome measures
| Measure |
Lupron + Docetaxel (75mg/m2) +Testosterone (RISING PSA)
n=25 Participants
GnRh (Leuprolide): Leuprolide LUPRON
Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle
Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days
|
Lupron + Docetaxel (75mg/m2) + Testosterone for (Metastatic)
n=37 Participants
GnRh (Leuprolide): Leuprolide LUPRON
Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle
Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days
|
Lupron +Docetaxel (70 mg/m2) +Testosterone (RISING PSA)
n=17 Participants
GnRh (Leuprolide): Leuprolide LUPRON
Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle
Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days
|
Lupron + Docetaxel (70 mg/m2) + Testosterone (Metastatic)
n=21 Participants
(Metastatic) GnRh (Leuprolide): Leuprolide LUPRON
Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle
Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days
|
|---|---|---|---|---|
|
PSA of <_ 0.05 ng/ml After Radical Prostatectomy or Radiation Therapy and PSA <_ 2.0 ng/ml for Patients With Clinical Metastases Without Prior Definitive Therapy
at 6 months post-treatment
|
9 participants
|
14 participants
|
13 participants
|
12 participants
|
|
PSA of <_ 0.05 ng/ml After Radical Prostatectomy or Radiation Therapy and PSA <_ 2.0 ng/ml for Patients With Clinical Metastases Without Prior Definitive Therapy
at 18 months post-treatment
|
0 participants
|
0 participants
|
3 participants
|
2 participants
|
SECONDARY outcome
Timeframe: at Cycle 1 and 2Population: A population pharmacokinetic model was fit to the data from all individuals simultaneously using a non-linear mixed effects modeling. This was performed using NONMEM. The NONMEM model accounts for between-patient, between-course, and residual variability (random effects) as well as parameter differences predicted by covariates (fixed effects).
Docetaxel Pharmacokinetic parameters for cycles 1 and 2.
Outcome measures
| Measure |
Lupron + Docetaxel (75mg/m2) +Testosterone (RISING PSA)
n=102 Participants
GnRh (Leuprolide): Leuprolide LUPRON
Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle
Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days
|
Lupron + Docetaxel (75mg/m2) + Testosterone for (Metastatic)
GnRh (Leuprolide): Leuprolide LUPRON
Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle
Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days
|
Lupron +Docetaxel (70 mg/m2) +Testosterone (RISING PSA)
GnRh (Leuprolide): Leuprolide LUPRON
Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle
Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days
|
Lupron + Docetaxel (70 mg/m2) + Testosterone (Metastatic)
(Metastatic) GnRh (Leuprolide): Leuprolide LUPRON
Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle
Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days
|
|---|---|---|---|---|
|
The Effects of Testosterone Administration on Docetaxel Pharmacokinetics.
Docetaxel clearance (Cycle 1)
|
23.9 L/hr
Standard Deviation 12.1
|
—
|
—
|
—
|
|
The Effects of Testosterone Administration on Docetaxel Pharmacokinetics.
Docetaxel clearance (Cycle 2)
|
23.6 L/hr
Standard Deviation 7.43
|
—
|
—
|
—
|
Adverse Events
Lupron and Docetaxel (75mg/m2) and Testosterone for 7 Days
Serious events: 36 serious events
Other events: 63 other events
Deaths: 0 deaths
Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 Days
Serious events: 8 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lupron and Docetaxel (75mg/m2) and Testosterone for 7 Days
n=63 participants at risk
GnRh (Leuprolide): Leuprolide LUPRON
Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle
Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days
|
Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 Days
n=39 participants at risk
GnRh (Leuprolide): Leuprolide LUPRON
Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle
Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
1.6%
1/63 • Number of events 1 • From the start of treatment through 30 days after completing treatment
|
0.00%
0/39 • From the start of treatment through 30 days after completing treatment
|
|
General disorders
Edema limbs
|
1.6%
1/63 • Number of events 1 • From the start of treatment through 30 days after completing treatment
|
0.00%
0/39 • From the start of treatment through 30 days after completing treatment
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
9.5%
6/63 • Number of events 6 • From the start of treatment through 30 days after completing treatment
|
10.3%
4/39 • Number of events 4 • From the start of treatment through 30 days after completing treatment
|
|
General disorders
Fever
|
3.2%
2/63 • Number of events 2 • From the start of treatment through 30 days after completing treatment
|
7.7%
3/39 • Number of events 3 • From the start of treatment through 30 days after completing treatment
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.6%
1/63 • Number of events 1 • From the start of treatment through 30 days after completing treatment
|
0.00%
0/39 • From the start of treatment through 30 days after completing treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
22.2%
14/63 • Number of events 18 • From the start of treatment through 30 days after completing treatment
|
2.6%
1/39 • Number of events 1 • From the start of treatment through 30 days after completing treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.6%
1/63 • Number of events 1 • From the start of treatment through 30 days after completing treatment
|
0.00%
0/39 • From the start of treatment through 30 days after completing treatment
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/63 • Number of events 1 • From the start of treatment through 30 days after completing treatment
|
0.00%
0/39 • From the start of treatment through 30 days after completing treatment
|
|
Investigations
Neutrophil count decrease
|
42.9%
27/63 • Number of events 49 • From the start of treatment through 30 days after completing treatment
|
0.00%
0/39 • From the start of treatment through 30 days after completing treatment
|
|
General disorders
Chest pain
|
1.6%
1/63 • Number of events 1 • From the start of treatment through 30 days after completing treatment
|
0.00%
0/39 • From the start of treatment through 30 days after completing treatment
|
|
General disorders
Pain
|
1.6%
1/63 • Number of events 1 • From the start of treatment through 30 days after completing treatment
|
0.00%
0/39 • From the start of treatment through 30 days after completing treatment
|
|
Cardiac disorders
Sinus Tachycardia
|
1.6%
1/63 • Number of events 1 • From the start of treatment through 30 days after completing treatment
|
0.00%
0/39 • From the start of treatment through 30 days after completing treatment
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis (excessive perspiration)
|
1.6%
1/63 • Number of events 1 • From the start of treatment through 30 days after completing treatment
|
0.00%
0/39 • From the start of treatment through 30 days after completing treatment
|
|
Vascular disorders
Thrombosis
|
1.6%
1/63 • Number of events 1 • From the start of treatment through 30 days after completing treatment
|
0.00%
0/39 • From the start of treatment through 30 days after completing treatment
|
|
Infections and infestations
Skin infection
|
0.00%
0/63 • From the start of treatment through 30 days after completing treatment
|
5.1%
2/39 • Number of events 2 • From the start of treatment through 30 days after completing treatment
|
Other adverse events
| Measure |
Lupron and Docetaxel (75mg/m2) and Testosterone for 7 Days
n=63 participants at risk
GnRh (Leuprolide): Leuprolide LUPRON
Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle
Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days
|
Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 Days
n=39 participants at risk
GnRh (Leuprolide): Leuprolide LUPRON
Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle
Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days
|
|---|---|---|
|
General disorders
Fatigue
|
90.5%
57/63 • Number of events 57 • From the start of treatment through 30 days after completing treatment
|
97.4%
38/39 • Number of events 38 • From the start of treatment through 30 days after completing treatment
|
|
Vascular disorders
Hot flashes
|
65.1%
41/63 • Number of events 41 • From the start of treatment through 30 days after completing treatment
|
76.9%
30/39 • Number of events 30 • From the start of treatment through 30 days after completing treatment
|
|
Nervous system disorders
Neuropathy
|
41.3%
26/63 • Number of events 26 • From the start of treatment through 30 days after completing treatment
|
64.1%
25/39 • Number of events 25 • From the start of treatment through 30 days after completing treatment
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
14.3%
9/63 • Number of events 9 • From the start of treatment through 30 days after completing treatment
|
17.9%
7/39 • Number of events 7 • From the start of treatment through 30 days after completing treatment
|
|
Blood and lymphatic system disorders
Neutropenia
|
65.1%
41/63 • Number of events 41 • From the start of treatment through 30 days after completing treatment
|
69.2%
27/39 • Number of events 27 • From the start of treatment through 30 days after completing treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
85.7%
54/63 • Number of events 54 • From the start of treatment through 30 days after completing treatment
|
97.4%
38/39 • Number of events 38 • From the start of treatment through 30 days after completing treatment
|
Additional Information
Dr. Dana Rathkopf
Memorial Sloan-Kettering Cancer Center
Phone: 646-422-4379
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place