A Phase II Study of Ara-C (Cytarabine) in Men With Androgen Independent Prostate Cancer (SLAP)
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|ClinicalTrials.gov Identifier: NCT00480090|
Recruitment Status : Completed
First Posted : May 30, 2007
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Cytarabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- 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.
- 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.
- 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.
- 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.
- Measurable disease response [ Time Frame: Every 3 cycles (9 weeks) ]Radiological measurement of effect. Measurement at baseline, and every 3 cycles
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 ClinicalTrials.gov identifier (NCT number): NCT00480090
|University Health Network|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Anthony Joshua, MD||University Health Network, Toronto|