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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00480090
Recruitment Status : Completed
First Posted : May 30, 2007
Last Update Posted : February 15, 2019
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Drug: Cytarabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Ara-C (Cytarabine) in Men With Androgen Independent Prostate Cancer
Study Start Date : April 2007
Actual Primary Completion Date : October 2010
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Cytarabine

Arm Intervention/treatment
Experimental: Cytarabine
eligible patients will receive cytarabine, starting at 075g/m2 and escalating to a maximum of 1.25g/m2, BID IV for 2 days every three weeks for 6 or more cycles if tolerated.
Drug: 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.

Primary Outcome Measures :
  1. PSA response [ Time Frame: 50% decline in PSA from baseline, confirmed by a second measurement ≥3 weeks later ]
    PSA levels will be collected at screening, baseline, 2 weeks following study termination, and upon followup to determine PSA level response to treatment.

Secondary Outcome Measures :
  1. Pain response [ Time Frame: Baseline median PPI with no concomitant increase in analgesic score/pain ]
    Patients will complete Present Pain Intensity (PPI) scale a baseline, every three weeks during treatment and at the end of study.

  2. QOL response [ Time Frame: Baseline to two measurements obtained at least three weeks apart ]
    Quality of Life (QOL) will be assessed with the Functional Assessment of Cancer Therapy - Prostate questionnaire, self administered by patients.

  3. PSA progression free survival [ Time Frame: Baseline and the date of PSA progression or the date of death due to prostate cancer, whichever occurs first. ]
    Time between randomization date and the date of PSA progression (>25% increase from baseline) or the date of death due to prostate cancer, whichever occurs first.

  4. Measurable disease response [ Time Frame: Every 3 cycles (9 weeks) ]
    Radiological measurement of effect. Measurement at baseline, and every 3 cycles

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00480090

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

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Responsible Party: University Health Network, Toronto Identifier: NCT00480090     History of Changes
Other Study ID Numbers: SLAP41206
First Posted: May 30, 2007    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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

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