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

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: GnRh (Leuprolide); Drug: Testosterone Gel; Drug: Docetaxel

• Registration Number: NCT00587431
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2008-01-04
• Study First Posted: 2008-01-07
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Results First Submitted: 2014-01-21
• Results First Submitted QC: 2014-08-05
• Results First Posted: 2014-08-21
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-20
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 102

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:

  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

Read More

Exclusion Criteria

• Clinically significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease.
• 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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	GnRh (Leuprolide)	-
1	Testosterone Gel	-
1	Docetaxel	-
2	GnRh (Leuprolide)	-
2	Testosterone Gel	-

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
The Effects of Testosterone Administration on Docetaxel Pharmacokinetics.	at Cycle 1 and 2	Docetaxel Pharmacokinetic parameters for cycles 1 and 2.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States