Skip to main content
OpenTrials
Completed

NCT Number: NCT00480090

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cytarabine

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Acronym: SLAP

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
May 30, 2007
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.