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A Phase II Study of Ara-C (Cytarabine) in Men With Androgen Independent Prostate Cancer (SLAP)
This study is currently recruiting participants.
Verified by University Health Network, Toronto, June 2007
First Received: May 28, 2007   Last Updated: June 26, 2007   History of Changes
Sponsored by: University Health Network, Toronto
Information provided by: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00480090
  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 mamalian 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 II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Study of Ara-C (Cytarabine) in Men With Androgen Independent Prostate Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The primary clinical endpoint of the study is PSA response following cytarabine treatment.

Secondary Outcome Measures:
  • The secondary clinical endpoints are pain response, QOL response, measurable disease response and PSA progression free survival.

  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

Contacts
Contact: Anthony Joshua, MD 416-946-4501 anthony.joshua@utoronto.ca

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

No publications provided

Study ID Numbers: SLAP41206
Study First Received: May 28, 2007
Last Updated: June 26, 2007
ClinicalTrials.gov Identifier: NCT00480090     History of Changes
Health Authority: Canada: Health Canada

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

Study placed in the following topic categories:
Antimetabolites
Anti-Infective Agents
Immunologic Factors
Genital Neoplasms, Male
Prostatic Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
Immunosuppressive Agents
Hormones
Antiviral Agents
Prostatic Neoplasms
Cytarabine
Androgens

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

ClinicalTrials.gov processed this record on September 11, 2009