Know Cancer

forgot password

An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Androgen-independent Prostate Cancer

Phase 2
18 Years
85 Years
Not Enrolling
Prostatic Neoplasms

Thank you

Trial Information

An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Androgen-independent Prostate Cancer

Inclusion Criteria:

The following patients may be eligible for this study:

- Patients with any histologically proven prostate cancer with measurable metastatic
disease or PSA progression > 20ng/ml after initial hormonal therapy will be eligible

- Patients must be maintained on androgen ablation therapy with a LHRH agonist or have
undergone orchiectomy

- Patients in whom bicalutamide or flutamide has been recently withdrawn must
demonstrate progression of disease and be at least 6 weeks and 4 weeks respectively,
beyond the discontinuation of such agents

- Patients taking PC-SPES must discontinue therapy for a minimum of 4 weeks

- For patients with disease progression defined solely by PSA increase: two consecutive
rises in PSA measurement, over a 4-week period (each separated from the previous by 2
weeks) - the last measurement must be at least 50% greater than the nadir PSA
achieved after the last therapeutic maneuver

- For patients who discontinued bicalutamide therapy prior to study entry, a third
rising PSA measurement is required 2 weeks from the second PSA measurement (i.e. over
a 6 week period)

- Must have a life expectancy of greater than three (3) months

- Bilirubin must be within normal limits. Transaminases (SGOT and/or SGPT) may be up
to 2.5 X institutional upper limit of normal if alkaline phosphatase is less than the
upper limit of normal, or alkaline phosphatase may be up to 4 X upper limit of normal
if transaminases are less than or equal to the upper limit of normal

- For patients with disease progression defined by measurable disease: changes in
measurable size of lymph nodes or parenchymal masses on physical or radiologic
examination (bone scan findings are not adequate to assess measurable disease).

Exclusion Criteria:

The following patients are not eligible for the study:

- Patients with symptomatic CNS metastases or leptomeningeal involvement

- Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1

- Patients with severe cardiac insufficiency

- Patients taking Coumadin or other warfarin-containing agents with the exception of
low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports

- Patients who received palliative radiotherapy to tumors located centrally less than 4
weeks (28 days) prior to planned enrollment date (palliative radiotherapy to isolated
peripheral bone metastases is allowed)

- Patients experiencing hormone withdrawal syndrome, or are 28 days post-withdrawal of
anti-androgen therapy (42 days for bicalutamide)

- Patients who have had more than one prior chemotherapy regimen for hormone-resistant
metastatic disease

- Patients with disease measurable only by bone scan

- Patients who have received corticosteroids within the past 28 days (may be waived
with approval from Novartis)

- History of another malignancy within 5 years prior to study entry except curatively
treated non-melanoma skin cancer

- Patients who have undergone major surgery for any cause less than 4 weeks prior to
study entry

- Patients with radiation therapy or chemotherapy within the last four weeks

- Patients with active or suspected acute or chronic uncontrolled infection including
abcesses or fistulae

- HIV+ patients

Type of Study:


Study Design:

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

Outcome Measure:

Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

January 2002

Completion Date:

Related Keywords:

  • Prostatic Neoplasms
  • prostate cancer
  • prostate
  • androgen independent
  • cancer
  • tumor
  • tumour
  • neoplasm
  • carcinoma
  • intravenous
  • epothilone
  • Neoplasms
  • Prostatic Neoplasms



Seattle Cancer Care Alliance Seattle, Washington  98109
Pacific Shores Medical Group Long Beach, California  90813
Cancer Institute of New Jersey (CINJ) New Brunswick, New Jersey  08901
California Pacific Medical Center San Francisco, California  94115
University of Maryland - Greenbaum Cancer Center Baltimore, Maryland  21201