Clinical trial NCT00587431: Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer
Official title: Docetaxel With Rapid Hormonal Cycling as a Treatment for Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate
Cancer
Docetaxel
03-076
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-01-07
Enrollment: 102
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Conclusion of the study (at 6 months then at 18 months post-treatment)
Secondary outcomes:
measure: The Effects of Testosterone Administration on Docetaxel Pharmacokinetics.
timeFrame: at Cycle 1 and 2
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Dana Rathkopf, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: