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Digoxin for Recurrent Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01162135
Recruitment Status : Completed
First Posted : July 14, 2010
Results First Posted : June 5, 2014
Last Update Posted : November 29, 2016
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Tracking Information
First Submitted Date  ICMJE July 12, 2010
First Posted Date  ICMJE July 14, 2010
Results First Submitted Date  ICMJE April 23, 2014
Results First Posted Date  ICMJE June 5, 2014
Last Update Posted Date November 29, 2016
Study Start Date  ICMJE September 2010
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2014)
Rate of Positive PSADT Outcome [ Time Frame: 6 months after treatment with digoxin ]
Proportion of patients at 6 months post-treatment with a PSADT >= 200% from baseline
Original Primary Outcome Measures  ICMJE
 (submitted: July 12, 2010)
To assess the rate of positive PSADT outcome [ Time Frame: 6 months after treatment with digoxin ]
Prostate antigen doubling time assessed by PSA marker
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2010)
To evaluate the safety and tolerance of digoxin [ Time Frame: Digoxin levels will be drawn C1D8, C1D15, and repeated every Cycle on day 1 for the next 5 cycles. (A cycle = 4wks) ]
To evaluate the safety and tolerance of diogoxin at 125 or 250 mcg/day (does will be chosen individually when the serum drug concentration reaches 0.8 ng/ml) in prostate cancer patients with evidence of biochemical progression following local treatment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Digoxin for Recurrent Prostate Cancer
Official Title  ICMJE A Pilot Phase II Study of Digoxin in Patients With Recurrent Prostate Cancer as Evident by a Rising PSA
Brief Summary The purpose of this study is to assess the effectiveness of dioxin on prohibiting prostate cancer progression as measured by PSADT (prostate-specific antigen doubling time).
Detailed Description This is a pilot phase II, open labeled single center study to assess the efficacy of digoxin on inhibiting PCa progression as measured by PSADT. The participants will take study drug digoxin, which is approved by FDA for the treatment of CHF, 125 or 250 mcg orally daily, titrated to the level of 0.8 - 2 ng/ml for total of 6 cycles (4 weeks/cycle). The lower dose of digoxin (such as 125 mcg/day) will be chosen if serum level reaches 0.8 ng/ml already. Patients may continue another 6 cycles if evident of clinical benefit.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Drug: Digoxin

The participants will take study drug digoxin, which is approved by FDA for the treatment of CHF, 125 or 250 mcg orally daily, titrated to the level of 0.8 - 2 ng/ml for total of 6 cycles (4 weeks/cycle). The lower dose of digoxin (such as 125 mcg/day) will be chosen if serum level reaches 0.8 ng/ml already. Patients may continue another 6 cycles if evident of clinical benefit.

It is possible that some patients may need to receive 500 mcg per day to reach this targeted drug level. No further titration will be allowed beyond this FDA approved digoxin dose.

Study Arms  ICMJE Experimental: Open Label Pilot Study
Intervention: Drug: Digoxin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2012)
16
Original Estimated Enrollment  ICMJE
 (submitted: July 12, 2010)
45
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • There must be a confirmed biochemical progression. Biochemical progression is defined as three rises in PSA levels, with each PSA determined at least 4 weeks apart, and each PSA value increase >0.2 ng/ml.
  • Baseline PSA must be determined within 4 weeks of study entry. At least 3 PSA values are necessary prior to the study entry to calculate PSA doubling time (PSADT) calculator.
  • Men with history of radical prostatectomy are required to have baseline PSA >1 ng/ml. Men treated with primary radiation therapy are required to have baseline PSA>2 ng/ml and greater than 150% rise from postradiation nadir.
  • PSA doubling time must be between 6 and 24 months.
  • All treatments including intermittent hormonal therapy must have been discontinued for > 6 months prior to study entry.
  • No clinical or radiological evidence of distant metastases
  • ECOG < 2 and adequate organ function
  • Men with history of radical prostatectomy are required to have baseline PSA >1 ng/ml. Men treated with primary radiation therapy are required to have baseline PSA>2 ng/ml and greater than 150% rise from postradiation nadir
  • Baseline PSA must be determined within 4 weeks of study entry. At least 3 PSA values are necessary to calculate PSA doubling time via PSADT calculator at: http://www.mskcc.org/mskcc/applications/nomograms/PSADoublingTime.aspx. PSA doubling time must be between 6 and 24 months.
  • All previous local modalities of treatment, including radiation and surgery, must have been discontinued at least 8 weeks prior to treatment in this study. Patients may have received prior systemic chemotherapy, hormonal therapy, biologic or vaccine therapy. All systemic treatments must have been discontinued for > 6 months prior to study entry.
  • Patients receiving intermittent hormonal therapy for their rising PSA state are considered eligible if testosterone level is above 150ng/dl and treatment was discontinued > 6 months and agree not to have additional injections while on study drug.
  • No clinical or radiological evidence of distant metastases (excluding prostascint scan/PET in absence of radiographic disease in Bone scan, CT scan or MRI if used). Lymph node up to 2 cm size is allowed for the study.
  • ECOG < 2 or Karnofsky Performance status >70% within 14 days before being registered for protocol therapy (Appendix B)
  • Normal organ function with acceptable initial laboratory values:
  • Absolute neutrophil count ≥ 1 x 109/L
  • Platelets > 50 x 109/L
  • Creatinine <1.5 mg/dL
  • Bilirubin <1.5 X ULN (institutional upper limits of normal)
  • AST (SGOT) and ALT (SGPT) ≤ 1.5 x ULN
  • Willingness to use adequate methods of contraception throughout study participation and for at least 3 months after completing therapy

Exclusion Criteria:

  • Metastatic disease or currently active second malignancy
  • History of Sinus Node Disease and AV Block, Accessory AV Pathway (Wolff-Parkinson-White Syndrome), history of Acute Myocardial Infarction.
  • Electrolyte imbalance (hypokalemia, hypo- or hypercalcemia, hypomagnesemia)
  • Severe pulmonary disease and hypoxia
  • Medical conditions such as uncontrolled hypertension, uncontrolled diabetes mellitus, active infectious hepatitis, type A, B or C, hypothyroidism or hyperthyroidism, which would, in the opinion of the investigator, make this protocol unreasonably hazardous.
  • Major thoracic or abdominal surgery within the prior 3 weeks.
  • Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).
  • Use of any prohibited concomitant medications: The washout period is at least 2 weeks before starting the study.
  • Insufficient time from last prior regimen or radiation exposure: Systemic therapies for prostate cancer within 28 days prior to digoxin; strontium-89 within 12 weeks; bicalutamide within 6 weeks.
  • Persistent Grade >2 treatment-related toxicity from prior therapy
  • History of any digoxin-related or drug induced anaphylactic reaction
  • Receipt of another investigational agent within 6 months of study entry. Patient must have recovered from all side effects of prior investigational therapy.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01162135
Other Study ID Numbers  ICMJE 10G.87
2009-43 ( Other Identifier: CCRRC )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
Study Sponsor  ICMJE Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jianqing Lin, MD Thomas Jefferson University
PRS Account Thomas Jefferson University
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP