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


Phase 1
18 Years
N/A
Not Enrolling
Both
Urologic Neoplasms, Prostate Cancer, Prostate Cancer Metastatic Disease

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Outcome Time Frame:

after 4 cycles of combination therapy

Safety Issue:

Yes

Principal Investigator

Dr. Sandy Srinivas

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Food and Drug Administration

Study ID:

PROS0033

NCT ID:

NCT01155791

Start Date:

April 2010

Completion Date:

October 2012

Related Keywords:

  • Urologic Neoplasms
  • Prostate Cancer
  • Prostate Cancer Metastatic Disease
  • Neoplasms
  • Neoplasm Metastasis
  • Prostatic Neoplasms
  • Urologic Neoplasms
  • Neoplasms, Second Primary

Name

Location

Stanford University School of MedicineStanford, California  94305-5317