Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Reproductive Control Agents

Methyltestosterone

Docetaxel

Leuprolide

Testosterone

Testosterone undecanoate

Testosterone enanthate

Testosterone 17 beta-cypionate

Tubulin Modulators

Antimitotic Agents

Androgens

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

GnRh (Leuprolide)

Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days (applied at approximately 9p)

Testosterone Gel

70 mg/m2 given on day o1 of each 3 week cycle

Dana Rathkopf, MD, PhD

We postulate that multiple apoptototic events are indusce through testosterone depletion and repletion with taxotere given in conjunction with androgen withdrawal.

Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer

Docetaxel Pharmacokinetic parameters for cycles 1 and 2.

Memorial Sloan Kettering Cancer Center

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 (75mg/m2) and Testosterone for 7 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

Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 Days

Total

Age, Continuous

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Dr. Dana Rathkopf

at 6 months post-treatment

at 18 months post-treatment

Lupron + Docetaxel (75mg/m2) +Testosterone (RISING PSA)

Lupron + Docetaxel (75mg/m2) + Testosterone for (Metastatic)

Lupron +Docetaxel (70 mg/m2) +Testosterone (RISING PSA)

(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

Lupron + Docetaxel (70 mg/m2) + Testosterone (Metastatic)

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

Docetaxel clearance (Cycle 1)

Docetaxel clearance (Cycle 2)

All Participants

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).

The Effects of Testosterone Administration on Docetaxel Pharmacokinetics.

Overall Study

Spots Global Cancer Trial Database for Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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