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

Phase 2
18 Years
Not Enrolling
Prostate, Cancer

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Trial Information

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

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

- Prior chemotherapy

- Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital,
St. Johns's Wort (hypericum perforatum) and ketoconazole is prohibited.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PSA of <_ 0.05 ng/ml after radical prostatectomy or radiation therapy and PSA <_ 2.0 ng/ml for patients with clincal metastases without prior definitive therapy

Outcome Time Frame:

Conclusion of the study

Safety Issue:


Principal Investigator

Dana Rathkopf, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

July 2003

Completion Date:

February 2008

Related Keywords:

  • Prostate
  • Cancer
  • Prostate
  • Cancer
  • Docetaxel
  • 03-076
  • Prostatic Neoplasms



Memorial Sloan Kettering Cancer Center New York, New York  10021