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Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

Inclusion Criteria

Eligibility Criteria:

- Male 18 years of age.

- Histologically confirmed adenocarcinoma of the prostate, stage D1 or D2.

- Failure of androgen ablation (orchiectomy or LHRH, flutamide).

- Patients must have PSA progression and progression in measurable disease.

- No prior history of systemic chemotherapy.

- No investigational drugs within 4 weeks of study entry.

- No radiation therapy or hormonal therapy within 4 weeks of study entry.

- No isotope therapy within 6 weeks of study entry.

- No antiandrogens within 4 weeks of study entry. Patients must continue LHRH.

- If patients had prior surgery, it must be at least 21 days prior to study entry, and
the patient must have recovered from all side effects.

- Patients must have stopped bisphosphonates 28 days prior to study entry.

- No prior malignancy allowed except for adequately treated basal cell or squamous cell
skin cancer, or adequately treated stage I or II cancer from which the patient is
currently in remission, and has been disease free for at least 5 years.

- Patients must have recovered from major infections and/or surgical procedures, and in
the opinion of the investigator not have significant active concurrent medical
illness, such as a history of significant neurologic or psychiatric disorders
including psychotic disorders, dementia, or seizures that would preclude protocol
treatment or survival.

- All patients must be informed of the investigational nature of the study and must
sign and give written informed consent in accordance with institutional and federal

- No other chemotherapeutic, biological response modifiers, radiation therapy,
corticosteroid therapy, or hormonal concomitant therapy (except continuation of LHRH)
may be given during treatment. Patients should not be planning on receiving
concomitant bisphosphonates.

- ECOG Performance Status = 0-3.

- WBC > or = 3500/ul or ANC > or = 1500/ul.

- Bilirubin < or = ULN.

- Creatinine < or = 2.0 mg/dl.

- Platelets > or = 100,000/ul.

- ALT or AST < 2.5 X ULN.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

August 2001

Completion Date:

December 2005

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • prostate
  • Prostatic Neoplasms



University of Washington Seattle, Washington  98195
Columbia Presbyterian Medical Center New York, New York  10032