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

Prostate Cancer Clinical Trial

— SLAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00480090
• Other study ID #: SLAP41206
• Status: Completed
• Phase: Phase 2
• Start date: April 2007
• Est. completion date: July 2011

Study information

• Verified date: February 2019
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA response	PSA levels will be collected at screening, baseline, 2 weeks following study termination, and upon followup to determine PSA level response to treatment.	50% decline in PSA from baseline, confirmed by a second measurement =3 weeks later
Secondary	Pain response	Patients will complete Present Pain Intensity (PPI) scale a baseline, every three weeks during treatment and at the end of study.	Baseline median PPI with no concomitant increase in analgesic score/pain
Secondary	QOL response	Quality of Life (QOL) will be assessed with the Functional Assessment of Cancer Therapy - Prostate questionnaire, self administered by patients.	Baseline to two measurements obtained at least three weeks apart
Secondary	PSA progression free survival	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.	Baseline and the date of PSA progression or the date of death due to prostate cancer, whichever occurs first.
Secondary	Measurable disease response	Radiological measurement of effect. Measurement at baseline, and every 3 cycles	Every 3 cycles (9 weeks)