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

NCT01155791 | Terminated Phase 1

• 3 other identifiers: PROS0033SU-05122010-600217356
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Urologic Neoplasms; Prostate Cancer; Prostate Cancer Metastatic Disease

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: Docetaxel; Drug: Biosyn; Drug: Prednisone

Interventions

Docetaxel DRUG

IV 75 mg/m2

combination sodium selenite and docetaxel

Biosyn DRUG

IV dosage varies

combination sodium selenite and docetaxel

Prednisone DRUG

5mg, orally

combination sodium selenite and docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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

Sponsors & Collaborators

• Sandy Srinivas: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Urologic Neoplasms; Prostatic Neoplasms

Interventions

Docetaxel; Prednisone

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Dr. Sandy Srinivas

  Stanford University

  PRINCIPAL INVESTIGATOR

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 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 15, 2017

Record last verified: 2017-03

Locations

US (1)