Clinical trial NCT00480090: A Phase II Study of Ara-C (Cytarabine) in Men With Androgen Independent Prostate Cancer
Official title: A Phase II Study of Ara-C (Cytarabine) in Men With Androgen Independent Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate
Androgen independent
Phase II
Second line
Androgen-independent prostate cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2007-05-30
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: PSA response
timeFrame: 50% decline in PSA from baseline, confirmed by a second measurement ≥3 weeks later
Secondary outcomes:
measure: Pain response
timeFrame: Baseline median PPI with no concomitant increase in analgesic score/pain
measure: QOL response
timeFrame: Baseline to two measurements obtained at least three weeks apart
measure: PSA progression free survival
timeFrame: Baseline and the date of PSA progression or the date of death due to prostate cancer, whichever occurs first.
measure: Measurable disease response
timeFrame: Every 3 cycles (9 weeks)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Anthony Joshua, MD
role: PRINCIPAL_INVESTIGATOR
References: