A Phase II Study of Ara-C (Cytarabine) in Men With Androgen Independent Prostate Cancer (SLAP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00480090
First received: May 28, 2007
Last updated: January 10, 2013
Last verified: January 2013

May 28, 2007
January 10, 2013
April 2007
October 2010   (final data collection date for primary outcome measure)
PSA response following cytarabine treatment [ Time Frame: 50% decline in PSA from baseline, confirmed by a second measurement ≥3 weeks later ] [ Designated as safety issue: No ]
The primary clinical endpoint of the study is PSA response following cytarabine treatment.
Complete list of historical versions of study NCT00480090 on ClinicalTrials.gov Archive Site
  • Pain response [ Time Frame: Baseline median PPI with no concomitant increase in analgesic score/pain ] [ Designated as safety issue: No ]
  • QOL response [ Time Frame: Baseline to two measurements obtained at least three weeks apart ] [ Designated as safety issue: No ]
  • PSA progression free survival [ Time Frame: Randomization date and the date of PSA progression or the date of death due to prostate cancer, whichever occurs first. ] [ Designated as safety issue: No ]
  • Measurable disease response [ Time Frame: Every 3 cycles (9 weeks) ] [ Designated as safety issue: No ]
The secondary clinical endpoints are pain response, QOL response, measurable disease response and PSA progression free survival.
Not Provided
Not Provided
 
A Phase II Study of Ara-C (Cytarabine) in Men With Androgen Independent Prostate Cancer
A Phase II Study of Ara-C (Cytarabine) in Men With Androgen Independent Prostate Cancer

This is a single-arm, open label phase II trial of the investigational agent, Ara-C (cytarabine), in patients diagnosed with hormone refractory prostate cancer whose disease has progressed on or deemed not suitable for standard chemotherapy with docetaxel. Ara-C appears to inhibit DNA synthesis and is cytotoxic to a wide variety of mammalian cells. Recent discoveries have suggested the role of gene fusions in the ETS family of transcription factors as important for the development of prostate cancer. Ara-C appears to block ETS genes, suggesting that it is worthwhile to explore Ara-C as a potential new treatment for patients with hormone refractory prostate cancer given that there is no standard of care for the proposed patient population. In this study, Ara-C will be administered intravenously for 2 days every 3 weeks (1 cycle). Treatment will be for 6 cycles if tolerated and may be continued in patients who are responding and do not have severe toxicity.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: Ara-C (Cytarabine)
Initially given at 1g/m2 bid for 2 days every 3 weeks over 2 hours. The dose will be escalated: level 1 - 1.25g/m2, level 2, 1.5g/m2.
Experimental: Cytarabine
Intervention: Drug: Ara-C (Cytarabine)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
July 2011
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Biopsy-proven prostate cancer or clinical picture consistent with metastatic prostate cancer with high level of serum PSA (> 20ng/ml)
  • At least 4 weeks after docetaxel treatment and have at least 2 consecutive rising PSAs measured at least 2 weeks apart
  • Progression on or intolerance of docetaxel chemotherapy
  • ECOG performance status ≤ 2
  • Adequate organ and marrow function

Exclusion Criteria:

  • Prior treatment with cytarabine
  • Receiving any other investigational or anticancer agents
  • Uncontrolled intercurrent illness
  • Active malignancy at any other site excluding squamous cell or basal cell carcinomas of the skin
  • Radiotherapy within the past 4 weeks
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00480090
SLAP41206
Yes
University Health Network, Toronto
University Health Network, Toronto
Not Provided
Principal Investigator: Anthony Joshua, MD University Health Network, Toronto
University Health Network, Toronto
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP