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A Phase II Study of Ixabepilone Prior to Surgery for High-risk Localized Prostate Cancer

Phase 2
Open (Enrolling)
Prostatic Diseases, Genital Neoplasms, Male, Urogenital Neoplasms, Genital Diseases, Male, Adenocarcinoma, Prostatic Neoplasms, Neoplasms, Glandular and Epithelial, Carcinoma

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Trial Information

A Phase II Study of Ixabepilone Prior to Surgery for High-risk Localized Prostate Cancer

Inclusion Criteria:

- Histologically-confirmed localized prostate cancer

- Predicted probability of recurrence >/= 30% as defined by the updated Kattan nomogram

- Pathologic material available for gene expression analysis including cancer present
in 2 or more cores and availability of unstained slides or formalin-fixed paraffin
embedded tissue blocks.

- No prior prostate cancer therapy (including hormonal, chemotherapy, radiation or

- Subjects must be considered as candidates for radical prostatectomy

- EGOG status

- Men of child-bearing potential are required to use an effective means of

- Required Initial Laboratory Values:

- ANC >/= 1500/uL

- Platelet Count >/= 100000/uL

- Creatinine Bilirubin AST < 2.5 X ULN

- ALT < 2.5 X ULN

- Hemoglobin >/= 9.0 g/dL

Exclusion Criteria:

- A history of significant ventricular arrhythmias

- Neuropathy (> grade 1)

- Recent (within 6 months) myocardial infarction, congestive heart failure, transient
ischemic attack or stroke

- Active angina, including active stable and unstable angina

- Acute deep venous thrombosis and/or pulmonary embolism in the past 6 months

- Any prior hormonal therapy including the use of PC Spes or estrogen containing

- Other co-existing malignancies or malignancies diagnosed within the last 5 years,
with the exception of basal cell carcinoma.

- Patients with malignancy diagnosed more than 5 years ago and are disease free for at
least 5 years are not excluded.

- Recent (within 4 weeks) surgery or incomplete healing from surgery

- Known history of hypersensitivity reaction to a drug formulated in Cremophor EL

- Treatment with a non-approved or investigational drug within 30 days before Day 1 of
trial treatment

- Active infection requiring antibiotic therapy, or serious intercurrent illness.

- Any other major illness that in the investigators judgment will substantially
increase the risk associated with the subject's participation in this study.

- Unwillingness or inability to comply with procedures required in this protocol.

Type of Study:


Study Design:

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

Outcome Measure:

To determine the biochemical response rate (defined as >/= 50% reduction in PSA from baseline to the post-therapy value) for non-castrate patients with localized prostate cancer and a >/= 30% risk of recurrence within 5 years.

Outcome Time Frame:

4 cycles

Safety Issue:


Principal Investigator

Mitchell E Gross, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cedars-Sinai Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

April 2008

Completion Date:

April 2012

Related Keywords:

  • Prostatic Diseases
  • Genital Neoplasms, Male
  • Urogenital Neoplasms
  • Genital Diseases, Male
  • Adenocarcinoma
  • Prostatic Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Carcinoma
  • prostate cancer
  • radical prostatectomy
  • ixabepilone
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Carcinoma
  • Genital Diseases, Male
  • Genital Neoplasms, Male
  • Neoplasms, Glandular and Epithelial
  • Prostatic Diseases
  • Prostatic Neoplasms
  • Urogenital Neoplasms



Cedars-Sinai Medical Center Los Angeles, California  90048