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Urologic NeoplasmsPhase 1NCT01155791

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

A Phase 1 study testing Docetaxel, Biosyn and Prednisone in people with Urologic Neoplasms and Prostate Cancer, run by Sandy Srinivas at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Docetaxel, Biosyn and Prednisone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
Apr 2010to Oct 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 32Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

Official title: A Phase I Study Evaluating the Efficacy and Safety of Sodium Selenite in Combination With Docetaxel in Castration-resistant Prostate Cancer

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.

Being tested
Docetaxel, Biosyn, Prednisone
Medical subject headings
Urologic Neoplasms, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01155791
Study groupRoleWhat they receive
combination sodium selenite and docetaxelExperimentalNot described
Receives: Drug: Docetaxel; Drug: Biosyn; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: after 4 cycles of combination therapy

  2. To determine the maximum tolerated dose (MTD)

    Measured: 1 cycle

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionOct 2012
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01155791
Sponsor's protocol ID
PROS0033
Other IDs
SU-05122010-6002, 17356
Status last verified
Mar 2017
First submitted
30 Jun 2010
Last updated
15 Mar 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Docetaxel, Biosyn and Prednisone in people with Urologic Neoplasms and Prostate Cancer, run by Sandy Srinivas at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01155791.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2017.

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