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

NCT00480090 | Completed Phase 2 DMC

• 1 other identifier: SLAP41206
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate; Androgen independent; Phase II; Second line; Androgen-independent prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pain response

  Baseline median PPI with no concomitant increase in analgesic score/pain

• QOL response

  Baseline to two measurements obtained at least three weeks apart

• PSA progression free survival

  Baseline and the date of PSA progression or the date of death due to prostate cancer, whichever occurs first.

• Measurable disease response

  Every 3 cycles (9 weeks)

Study Arms (1)

Cytarabine

EXPERIMENTAL

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.

Drug: Cytarabine

Interventions

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.

Cytarabine

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Cytarabine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Anthony Joshua, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2007
• First Posted: May 30, 2007
• Study Start: April 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: July 1, 2011
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

CA (1)