Phase I Sodium Selenite in Combination With Docetaxel in Castration-resistant Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT01155791|
Recruitment Status : Terminated
First Posted : July 2, 2010
Last Update Posted : March 15, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Urologic Neoplasms Prostate Cancer Prostate Cancer Metastatic Disease||Drug: Docetaxel Drug: Biosyn Drug: Prednisone||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study Evaluating the Efficacy and Safety of Sodium Selenite in Combination With Docetaxel in Castration-resistant Prostate Cancer|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
|Experimental: combination sodium selenite and docetaxel||
IV 75 mg/m2
IV dosage varies
- 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 ]
- To determine the maximum tolerated dose (MTD) [ Time Frame: 1 cycle ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155791
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Dr. Sandy Srinivas||Stanford University|
|Responsible Party:||Sandy Srinivas, Associate Professor, Stanford University|
|Other Study ID Numbers:||
SU-05122010-6002 ( Other Identifier: Stanford University )
17356 ( Other Identifier: Stanford IRB )
|First Posted:||July 2, 2010 Key Record Dates|
|Last Update Posted:||March 15, 2017|
|Last Verified:||March 2017|
Genital Neoplasms, Male
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal