Vidaza to Restore Hormone Thx Prostate

NCT00384839 | Completed Phase 2 Results

• 1 other identifier: 05015
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 13

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With PSA Doubling Time >=3 Months.

  To determine if Vidaza can convert hormone-refractory prostate cancer to a hormone-responsive state. This will be assessed by the proportion of patients who have a documented prostate specific antigen (PSA) doubling time \>3= months.

  Until progression or up to a maximum of 12 cycles

Secondary Outcomes (5)

• PSA Response Rate

  Every 8 weeks for 1 year.

• Objective Response Rate by Recist (ORR)

  Every 8 weeks for 1 year.

• Progression-free Survival

  Up to 1.5 year.

• 1-year Overall Survival (OS)

  Up to 1 year.

• Changes in Fetal Hemoglobin (HbF) With Time.

  Up to 1 year.

Study Arms (1)

1

EXPERIMENTAL

azacitidine for injectable suspension

Drug: azacitidine for injectable suspension

Interventions

azacitidine for injectable suspension DRUG

Vidaza: 75 mg/m2 for 5 consecutive days (Days 1-5) of each 28 day cycle. A cycle will equal to 28 days. Patient will receive a maximum of 12 cycles.

Also known as: Vidaza™

1

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• US Oncology Research: lead
• Celgene Corporation: collaborator
• University of Southern California: collaborator

Study Sites (13)

Rocky Mountain Cancer Center-Midtown

Denver, Colorado, 80218, United States

Location

Cancer Centers of Florida, P.A.

Ocoee, Florida, 34761, United States

Location

Minnesota Oncology Hematology, P.A.

Minneapolis, Minnesota, 55404, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89109, United States

Location

New York Oncology Hematology, P.C.

Albany, New York, 12208, United States

Location

Raleigh Hematology Oncology Associates

Cary, North Carolina, 27511, United States

Location

Northwestern Carolina Oncology Hematology

Hickory, North Carolina, 28602, United States

Location

Texas Oncology, P.A.

Dallas, Texas, 75246, United States

Location

Texas Oncology, P.A.

Fort Worth, Texas, 76104, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

Deke Slayton Cancer Center

Webster, Texas, 77598, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Cancer Care Nrothwest-South

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Azacitidine

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)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Limitations and Caveats

Further development of azacitidine in patients with prostate cancer may be warranted in randomized trials, alone and in combination with hormonal therapy, chemotherapy and histone deacytelase inhibitors

Results Point of Contact

• Title: Dr. Guru Sonpavde
• Organization: Texas Oncology, P.A

Guru.Sonpavde@USOncology.com

(281) 332-7505

Study Officials

• Guru Sonpavde, MD

  US Oncology Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: October 4, 2006
• First Posted: October 6, 2006
• Study Start: April 1, 2006
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: October 25, 2018
• Results First Posted: October 25, 2018

Record last verified: 2018-09

Locations

US (13)