Clinical trial NCT00384839: Vidaza to Restore Hormone Thx Prostate
Official title: Phase II Study for the Use of Vidaza™ to Restore Responsiveness of Patients' Prostate Cancers to Hormonal Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: US Oncology Research
Sponsor class: INDUSTRY
Collaborators: name: Celgene Corporation
name: University of Southern California
First posted: 2006-10-06
Enrollment: 36
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: The purpose of this research study is to find out what effects (good and bad) Vidaza has on patients with prostate cancer. This investigational drug is not approved by the Food and Drug Administration (FDA) for the treatment of prostate cancer; however, it is approved in myelodysplastic syndrome - a bone marrow disease. The pharmaceutical company involved in this study, Pharmion Corporation, is the manufacturer of Vidaza.

Detailed description: This is an open label Phase II study. Patients will receive Vidaza for 5 consecutive days (Days 1- 5) of each 28-day cycle. Complete androgen ablation will be continued. Response will be assessed after a minimum of 2 cycles (evaluable patients). PSA response will be evaluated prior to each cycle and % fetal hemoglobin will be evaluated prior to each odd cycle (excluding Cycle 1). Patients will be treated until clinical progression up to a maximum of 12 cycles. A total of 35 patients with advanced metastatic HRPC will be enrolled in this trial.

Eligibility criteria: INCLUSION CRITERIA:

* A diagnosis of histologically confirmed, progressive, advanced metastatic, or nonmetastatic prostate cancer with documented PSA progression, with a calculated PSA doubling time \<3 months, on complete androgen ablation therapy. PSA progression, with or without clinical progression (symptomatic/radiologic as per RECIST) is required; measurable disease is not required.

Baseline PSA values must be followed by 2 serial increases at least 2 weeks apart (no upper limit for time for these 2 samples). Calculated PSA doubling time, for the above PSA values must be \<3 months. An automated PSA doubling time calculator may be found at www.mskcc.org/mskcc/html/10088.cfm (see study tools).

* Currently on complete androgen ablation hormone therapy (an LHRH agonist plus an antiandrogen) with testosterone level \<50ng/dL). Patients who are on LHRH agonist or other antiandrogenic therapy at entry will continue that therapy while on this study. Anti-androgen withdrawal is not necessary and is precluded before enrollment on the trial. The details of that therapy must be recorded in the CRF. Patients who have had an orchiectomy and who are on antiandrogen therapy are permitted on study.
* An elevated PSA level for patients progressing by PSA criteria is required (see protocol for specific detail).
* Has a Karnofsky Performance Status \>70
* Is greater than 18 years of age
* Must meet specific lab values for the following criteria: granulocyte, platelet count, total bilirubin, AST and ALT, serum creatinine, calculated creatinine clearance \& urinalysis (see protocol for specific detail).
* If fertile, the patient has agreed to use an acceptable method of birth control to avoid fathering a child for the duration of the study and for a period of 2 months thereafter.
* Has signed a Patient Informed Consent Form
* Has signed a Patient Authorization Form

EXCLUSION CRITERIA:

* Has only clinical progression without evidence of PSA progression
* Has received prior chemotherapy
* Has had prior treatment with Vidaza
* Has a history of hypersensitivity to any component of Vidaza (mannitol)
* Has a history of New York Heart Association (NYHA) heart disease Class III or IV (Appendix III) or myocardial infarction within 6 months prior to Day 1 or unstable arrhythmia or evidence of ischemia on electrocardiogram (ECG)
* Is receiving concurrent immunotherapy
* Is receiving concurrent bisphosphonate therapy; long-standing bisphosphonate therapy (initiated \>8 weeks prior to registration) is acceptable. Bisphosphonates started within the prior 8 weeks will not be allowed since this may affect other study endpoints and render their interpretation difficult.
* Has received treatment with radiation therapy, surgery, chemotherapy, ketoconazole, corticosteroids, or an investigational agent within 1 month prior to registration, (6 weeks for radiation therapy, nitrosureas or Mitomycin C)
* Has evidence of central nervous system (CNS) involvement
* Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection that requires systemic therapy
* Has a serious uncontrolled nonmalignant disease (liver failure, or other condition) that could compromise protocol objectives in the opinion of the Investigator
* Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin), which could affect the diagnosis or assessment of any of the study drugs
* Is known to be positive for the human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
* Is unable to comply with requirements of study

Primary outcomes:
measure: Percentage of Patients With PSA Doubling Time >=3 Months.
timeFrame: Until progression or up to a maximum of 12 cycles
Secondary outcomes:
measure: PSA Response Rate
timeFrame: Every 8 weeks for 1 year.
measure: Objective Response Rate by Recist (ORR)
timeFrame: Every 8 weeks for 1 year.
measure: Progression-free Survival
timeFrame: Up to 1.5 year.
measure: 1-year Overall Survival (OS)
timeFrame: Up to 1 year.
measure: Changes in Fetal Hemoglobin (HbF) With Time.
timeFrame: Up to 1 year.
Other outcomes:
Locations:
city: Denver
country: United States
facility: Rocky Mountain Cancer Center-Midtown
state: Colorado
city: Ocoee
country: United States
facility: Cancer Centers of Florida, P.A.
state: Florida
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Albany
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: Cary
country: United States
facility: Raleigh Hematology Oncology Associates
state: North Carolina
city: Hickory
country: United States
facility: Northwestern Carolina Oncology Hematology
state: North Carolina
city: Dallas
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Webster
country: United States
facility: Deke Slayton Cancer Center
state: Texas
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Spokane
country: United States
facility: Cancer Care Nrothwest-South
state: Washington
Study officials:
affiliation: US Oncology Research
name: Guru Sonpavde, MD
role: PRINCIPAL_INVESTIGATOR
References: