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We postulate that multiple apoptototic events are indusce through testosterone depletion and repletion with taxotere given in conjunction with androgen withdrawal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GnRh (Leuprolide) | Drug | Leuprolide LUPRON |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Conclusion of the study (at 6 months then at 18 months post-treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| The Effects of Testosterone Administration on Docetaxel Pharmacokinetics. | Docetaxel Pharmacokinetic parameters for cycles 1 and 2. | at Cycle 1 and 2 |
Not provided
Inclusion Criteria:
Diagnosis of prostate adenocarcinoma histologically confirmed at MSKCC or SKCCC.
Patient must have a serum testosterone > 180 ng/dl.
Karnofsky performance status (KPS)>_70%.
Patients must have adequate organ function as defined by the following
laboratory criteria:
WBC >_ 3500/mm3
ANC >_1500/mm3
Platelet count >100,000/mm3
Hemoglobin >8.0g/dL
Creatinine <1.6mg/dl
Total Bilirubin WNL (unless due to Gilbert's disease and other LFTs are WNL)
SGOT and SGPT If alkaline phosphatase is _< 2.5 x ULN, any elevations in
AST/ALT; OR if AST/ALT is _<1.5 x ULN, any elevation in alkaline phos
Prior hormonal therapy is allowed as:
Patients must be at least 18 years of age.
Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dana Rathkopf, MD, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
Not provided
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
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 Days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | participants | Conclusion of the study (at 6 months then at 18 months post-treatment) |
|
From the start of treatment through 30 days after completing treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | CTCAE 3.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dana Rathkopf | Memorial Sloan-Kettering Cancer Center | 646-422-4379 | rathkopd@mskcc.org |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
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| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D016729 | Leuprolide |
| D007273 | Injections, Intramuscular |
| D013739 | Testosterone |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Testosterone Gel | Drug | Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days (applied at approximately 9p) |
|
|
| Docetaxel | Drug | 70 mg/m2 given on day o1 of each 3 week cycle |
|
|
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 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 |
| OG003 | 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 |
|
|
| Secondary | The Effects of Testosterone Administration on Docetaxel Pharmacokinetics. | Docetaxel Pharmacokinetic parameters for cycles 1 and 2. | 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). | Posted | Mean | Standard Deviation | L/hr | at Cycle 1 and 2 |
|
|
|
| 36 |
| 63 |
| 63 |
| 63 |
| EG001 | 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 | 8 | 39 | 39 | 39 |
| Edema limbs | General disorders | CTCAE 3.0 | Systematic Assessment |
|
| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE 3.0 | Systematic Assessment |
|
| Fever | General disorders | CTCAE 3.0 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE 3.0 | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE 3.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE 3.0 | Systematic Assessment |
|
| Neutrophil count decrease | Investigations | CTCAE 3.0 | Systematic Assessment |
|
| Chest pain | General disorders | CTCAE 3.0 | Systematic Assessment |
|
| Pain | General disorders | CTCAE 3.0 | Systematic Assessment |
|
| Sinus Tachycardia | Cardiac disorders | CTCAE 3.0 | Systematic Assessment |
|
| Hyperhidrosis (excessive perspiration) | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | CTCAE 3.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE 3.0 | Systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D000091662 |
| Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |