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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
 Drug: Ara-C (Cytarabine)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Ara-C (Cytarabine) in Men With Androgen Independent Prostate Cancer

Resource links provided by NLM:

Drug Information available for: Cytarabine
U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: April 2007
Study Completion Date: July 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cytarabine 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00480090

Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Anthony Joshua, MD University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00480090     History of Changes
Other Study ID Numbers: SLAP41206
Study First Received: May 28, 2007
Last Updated: January 10, 2013
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Prostate
Androgen independent
Phase II
Second line
Androgen-independent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Cytarabine
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
 Physiological Effects of Drugs
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 19, 2013