Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer
NCT ID: NCT00587431
Last Updated: 2023-11-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
102 participants
INTERVENTIONAL
2003-07-31
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
GnRh (Leuprolide)
Leuprolide LUPRON
Testosterone Gel
Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days (applied at approximately 9p)
Docetaxel
70 mg/m2 given on day o1 of each 3 week cycle
2
GnRh (Leuprolide)
Leuprolide LUPRON
Testosterone Gel
Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days (applied at approximately 9p)
Interventions
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GnRh (Leuprolide)
Leuprolide LUPRON
Testosterone Gel
Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days (applied at approximately 9p)
Docetaxel
70 mg/m2 given on day o1 of each 3 week cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
1. Neoadjuvant treatment prior to radiation therapy or radical pmstatectomy, provided that the total duration of therapy does not exceed 6 months (Proscar is not considered a hormone therapy).
2. One cycle of intermittent therapy up to a maximum exposure of 6 months (Proscar is not considered a hormone therapy).
* 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
* Uncontrolled serious active infection.
* Anticipated survival of less than 3 months.
* Active CNS or epiduraltumor
* Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests
* Peripheral neuropathy \>\_ grade 3.
* Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80.
* Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 6 months after completion of the treatment.
* Prior chemotherapy
* Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, St. Johns's Wort (hypericum perforatum) and ketoconazole is prohibited.
18 Years
MALE
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Dana Rathkopf, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Other Identifiers
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03-076
Identifier Type: -
Identifier Source: org_study_id
NCT00070369
Identifier Type: -
Identifier Source: nct_alias
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