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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00587431
• Other study ID #: 03-076
• Status: Completed
• Phase: Phase 2
• Start date: July 2003
• Est. completion date: February 2008

Study information

• Verified date: October 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Other known NCT identifiers

• NCT00070369

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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		Conclusion of the study (at 6 months then at 18 months post-treatment)
Secondary	The Effects of Testosterone Administration on Docetaxel Pharmacokinetics.	Docetaxel Pharmacokinetic parameters for cycles 1 and 2.	at Cycle 1 and 2