NCT01155791

TerminatedPhase 1

Phase I Sodium Selenite in Combination With Docetaxel in Cas...

Sandy Srinivas Source

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Other study identifiers

Sponsor study identifier

PROS0033

Secondary identifiers

SU-05122010-6002

OTHER · Stanford University

17356

OTHER · Stanford IRB

Study Type

interventional

Actual enrollment (reported)

2

Locations

1 country

Sites

1

Timeline

Study Start

April 2010

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

October 2012

Actual (reported)

Study Completion

October 2012

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 2 participants
Study completion date: October 2012
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 2010
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
June 30, 2010
Actual (reported)
First Posted
July 2, 2010
Actual (reported)
Primary Completion
October 2012
Actual (reported)
Study Completion
October 2012
Actual (reported)

Last Updated: March 15, 2017
Status Verified: March 2017
Last Update Submitted: March 13, 2017

Conditions

Prostate Cancer Prostate Cancer Metastatic Disease Urologic Neoplasms

Outcome Measures

Primary Outcomes (2)

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
after 4 cycles of combination therapy
To determine the maximum tolerated dose (MTD)
1 cycle

Study Arms (1)

combination sodium selenite and docetaxel

EXPERIMENTAL

Drug: DocetaxelDrug: BiosynDrug: Prednisone

Interventions

DocetaxelDrug

IV 75 mg/m2

combination sodium selenite and docetaxel

BiosynDrug

IV dosage varies

combination sodium selenite and docetaxel

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

Sandy Srinivas
Otherlead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

MeSH Terms

Conditions

Urologic NeoplasmsProstatic Neoplasms

Interventions

DocetaxelPrednisone

Condition Hierarchy (Ancestors)

Urogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrologic DiseasesGenital Neoplasms, MaleGenital Diseases, Male

Study Officials

Dr. Sandy Srinivas
Stanford University
PRINCIPAL INVESTIGATOR

Enrollment

2 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Associate Professor

Study Record Dates

First Submitted

June 30, 2010

First Posted

July 2, 2010

Study Start

April 2010

Date type not reported

This date has not been verified as actual or estimated.

NCT00003633

Combination Chemotherapy in Treating Patients With Advanced Prostate Cancer

Phase 1Unknown

NCT00808418

A Study to Determine the Maximum Tolerated Dose of Elesclomol Sodium Given With a Fixed Dose of Docetaxel and Prednisone in Patients With Metastatic Prostate Cancer

Phase 1Completed

NCT00215709

Bi-Weekly Administration of Docetaxel for Older Men With Hormone Refractory Prostate Cancer

Phase 1Completed

NCT00559429

Study of Docetaxel +153 Sm-EDTMP in Patients With Hormone-Refractory Prostate Cancer

Phase 1Completed

NCT01741753

BKM120+Abiraterone Acetate for Metastatic CRPC

Phase 1Terminated

NCT00895115

Vitamin E Supplements in Preventing Cancer in Patients at Risk of Prostate Cancer or Who Have Prostate Cancer

Phase 1Completed

PrednisoneDrug

5mg, orally

combination sodium selenite and docetaxel

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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.

You may not qualify if:

\. More than 1 prior chemotherapy
\. 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
\. 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.
\. 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
\. Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.
\. Known or prior treated brain metastases.
\. History of hypersensitivity to docetaxel
\. 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.
\. History of myocardial infarction or unstable angina within 6 months prior to study enrollment
+1 more criteria

Contact the study team to confirm eligibility.

Genital Diseases

Prostatic Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Primary Completion

October 2012

Actual (reported)

Study Completion

October 2012

Actual (reported)

Last Updated

March 15, 2017

Record last verified: 2017-03

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01155791
Data provider: ClinicalTrials.gov
Source updated: 2017-03-15
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:29:40 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

combination sodium selenite and docetaxel

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations