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Phase I Sodium Selenite in Combination With Docetaxel in Castration-resistant Prostate Cancer

Primary Purpose

Urologic Neoplasms, Prostate Cancer, Prostate Cancer Metastatic Disease

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Docetaxel
Biosyn
Prednisone
Sponsored by
Sandy Srinivas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urologic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histologically confirmed adenocarcinoma of the prostate
  2. Castration-resistant prostate cancer requires the following 3 criteria:

    • Failure of first line bilateral orchiectomy or therapy with an LHRH agonist,
    • A rising PSA on 3 consecutive occasions at least 1 week apart (but not limited to the 30 day screening period), AND
    • A castrate level of testosterone (<50ng/dL)
  3. PSA doubling time (PSADT) > 1 months
  4. Failure on docetaxel chemotherapy as defined by a rising PSA .
  5. A minimum PSA of 2 ng/mL
  6. Age >=18 years
  7. Life expectancy greater than 6 months
  8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or Karnofsky performance status >=80%
  9. Bone metastases will be allowed
  10. The subject has a QTcB (Bazett corrected) or QTcF (Frederica corrected) < 470 msec.
  11. Ability to understand and the willingness to sign a written informed consent document.
  12. Willingness to stay on docetaxel chemotherapy despite rising PSA level.

Exclusion Criteria:1. Radiotherapy for prostate cancer within 28 days prior to Day 1.

2. More than 1 prior chemotherapy

3. Inadequate organ function, as evidenced by any of the following at screening:

  • Absolute neutrophil count (ANC) < 1500/uL
  • Platelet count <= 100 x 10^9/L
  • Total bilirubin >= ULN
  • AST, and/or ALT > 1.5 x the upper limit of normal (ULN) with a concomitant alkaline phosphastase >2.5 X ULN
  • Serum creatinine > 2.0 mg/dL
  • Hemoglobin < 9 g/dL

    4. Men with reproductive potential who do not agree to use an accepted and effective method of contraception during the study treatment period and for at least 3 months after completion of the study treatment.

    5. History of other malignancies within 5 years prior to Day 1 except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma, squamous-cell carcinoma of the skin, or early-stage bladder cancer

    6. Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.

    7. Known or prior treated brain metastases.

    8. History of hypersensitivity to docetaxel

    9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure ,unstable angina pectoris, cardiac arrhythmia, significant vascular disease (e.g. aortic aneurysm, aortic dissection), symptomatic peripheral vascular disease, or psychiatric illness/social situations that would limit compliance with study requirements.

    10. History of myocardial infarction or unstable angina within 6 months prior to study enrollment

    11. History of stroke or transient ischemic attack within 6 months prior to study enrollment 12. The subject is known to be positive for the human immunodeficiency virus (HIV) and is receiving antiretroviral 12. Willingness to stay on docetaxel chemotherapy despite rising PSA level.

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

combination sodium selenite and docetaxel

Arm Description

Outcomes

Primary Outcome Measures

To determine the safety and tolerability of the combination sodium selenite and docetaxel after 4 cycles of combination therapy using the NCI Common Toxicity Criteria v3.0 grading system for adverse events
To determine the maximum tolerated dose (MTD)

Secondary Outcome Measures

Full Information

First Posted
June 30, 2010
Last Updated
March 13, 2017
Sponsor
Sandy Srinivas
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1. Study Identification

Unique Protocol Identification Number
NCT01155791
Brief Title
Phase I Sodium Selenite in Combination With Docetaxel in Castration-resistant Prostate Cancer
Official Title
A Phase I Study Evaluating the Efficacy and Safety of Sodium Selenite in Combination With Docetaxel in Castration-resistant Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Study Start Date
April 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sandy Srinivas

4. Oversight

5. Study Description

Brief Summary
Selenium, in the form of inorganic Sodium Selenite, may be useful for treating existing prostate cancer. This idea is based on data from our laboratory showing that 1) prostate cancer cells are more sensitive to Selenium (Sodium Selenite)-induced apoptosis than normal prostate epithelial cells, 2) Selenite induces significant growth inhibition of well established prostate cancer tumors in mice at doses that have no detectable toxicity, and 3) Selenite disrupts AR signaling, and that the inhibition of AR expression and activity by Selenite occurs via a redox mechanism involving GSH, superoxide, and Sp1. Altogether, these findings suggest that Selenium may be useful in a variety of potential indications in the natural history of prostate cancer, including both hormone sensitive and castrate resistant prostate cancer, as a single agent, or in combination with radiation, chemotherapy or conventional hormone therapy. Selenite is a potential novel inhibitor of AR expression and function in prostate cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urologic Neoplasms, Prostate Cancer, Prostate Cancer Metastatic Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
combination sodium selenite and docetaxel
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
IV 75 mg/m2
Intervention Type
Drug
Intervention Name(s)
Biosyn
Intervention Description
IV dosage varies
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
5mg, orally
Primary Outcome Measure Information:
Title
To determine the safety and tolerability of the combination sodium selenite and docetaxel after 4 cycles of combination therapy using the NCI Common Toxicity Criteria v3.0 grading system for adverse events
Time Frame
after 4 cycles of combination therapy
Title
To determine the maximum tolerated dose (MTD)
Time Frame
1 cycle

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed adenocarcinoma of the prostate Castration-resistant prostate cancer requires the following 3 criteria: Failure of first line bilateral orchiectomy or therapy with an LHRH agonist, A rising PSA on 3 consecutive occasions at least 1 week apart (but not limited to the 30 day screening period), AND A castrate level of testosterone (<50ng/dL) PSA doubling time (PSADT) > 1 months Failure on docetaxel chemotherapy as defined by a rising PSA . A minimum PSA of 2 ng/mL Age >=18 years Life expectancy greater than 6 months Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or Karnofsky performance status >=80% Bone metastases will be allowed The subject has a QTcB (Bazett corrected) or QTcF (Frederica corrected) < 470 msec. Ability to understand and the willingness to sign a written informed consent document. Willingness to stay on docetaxel chemotherapy despite rising PSA level. Exclusion Criteria:1. Radiotherapy for prostate cancer within 28 days prior to Day 1. 2. More than 1 prior chemotherapy 3. Inadequate organ function, as evidenced by any of the following at screening: Absolute neutrophil count (ANC) < 1500/uL Platelet count <= 100 x 10^9/L Total bilirubin >= ULN AST, and/or ALT > 1.5 x the upper limit of normal (ULN) with a concomitant alkaline phosphastase >2.5 X ULN Serum creatinine > 2.0 mg/dL Hemoglobin < 9 g/dL 4. Men with reproductive potential who do not agree to use an accepted and effective method of contraception during the study treatment period and for at least 3 months after completion of the study treatment. 5. History of other malignancies within 5 years prior to Day 1 except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma, squamous-cell carcinoma of the skin, or early-stage bladder cancer 6. Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study. 7. Known or prior treated brain metastases. 8. History of hypersensitivity to docetaxel 9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure ,unstable angina pectoris, cardiac arrhythmia, significant vascular disease (e.g. aortic aneurysm, aortic dissection), symptomatic peripheral vascular disease, or psychiatric illness/social situations that would limit compliance with study requirements. 10. History of myocardial infarction or unstable angina within 6 months prior to study enrollment 11. History of stroke or transient ischemic attack within 6 months prior to study enrollment 12. The subject is known to be positive for the human immunodeficiency virus (HIV) and is receiving antiretroviral 12. Willingness to stay on docetaxel chemotherapy despite rising PSA level.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Sandy Srinivas
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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Phase I Sodium Selenite in Combination With Docetaxel in Castration-resistant Prostate Cancer

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