Digoxin for Recurrent Prostate Cancer
This study has been completed.
Information provided by (Responsible Party):
Thomas Jefferson University
First received: July 12, 2010
Last updated: July 25, 2014
Last verified: July 2014
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).
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Pilot Phase II Study of Digoxin in Patients With Recurrent Prostate Cancer as Evident by a Rising PSA
Primary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2013 (Final data collection date for primary outcome measure)
Experimental: Open Label Pilot Study
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.
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.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162135
|Thomas Jefferson University
|Philadelphia, Pennsylvania, United States, 19107 |
Thomas Jefferson University
||Jianqing Lin, MD
||Thomas Jefferson University
||Thomas Jefferson University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 12, 2010
|Results First Received:
||April 23, 2014
||July 25, 2014
||United States: Institutional Review Board
Keywords provided by Thomas Jefferson University:
Recurrent Prostate Cancer
Prostate Specific Antigen
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 25, 2016
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs