Prostate Cancer
A Phase I/II Study of TRC105 in Metastatic Castrate Resistant Prostate Cancer
NCI-10-C-0062, NCT01090765
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Investigator(s): |
William L. Dahut, M.D. Principal Investigator Phone: 301-435-8183 dahutw@mail.nih.gov
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Laura D. Otten, R.N., B.S.N., O.C.N. Medical Oncology Referral Coordinator Phone: 301-451-1228 1-866-611-6310 (Toll Free) Fax: 301-480-0919 ottenl@mail.nih.gov
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Key Eligibility Criteria:
- Diagnosis of metastatic progressive castrate-resistant prostate cancer despite surgical castration or ongoing use of gonadotropin-releasing hormone agonists with confirmed castrate levels of testosterone
- Clinically progressive measurable disease evidenced by any of the following:
- Two consecutively rising PSA values at a minimum of 1-week intervals (2.0 ng/mL is the minimum starting value for PSA)
- Appearance of two or more new lesions on bone scans
- Progressive measurable disease by RECIST v1.1
- Measurable or non-measurable disease on imaging studies
- Patients on flutamide for at least 6 months must have disease progression at least 4 weeks after withdrawal
- Patients on bicalutamide or nilutamide for at least 6 months must have progression at least 6 weeks after withdrawal
- ECOG 0–2
- Absolute neutrophil count ≥ 1,500/mcL
- Platelets ≥ 100,000/mcL
- Total bilirubin ≤ 1.5 x upper normal limits (ULN)
- AST/ALT ≤ 2.5 x ULN
- Creatinine ≤ 1.5 x ULN or creatinine clearance greater than or equal to 40 mL/min/1.73 m2 for patients with creatinine levels above institutional normal, as calculated by the Cockcroft-Gault formula
- Continued suppression of testosterone production by appropriate usage of GnRH agonists or antagonists is required for all patients who have not undergone bilateral surgical castration
- Recovered from any acute toxicity related to prior therapy, including surgery
Study Outline:
- TRC105 will be administered by IV infusion (through a vein) given at the NIH Clinical Center every 2 weeks on Days 1 and 15 (+/- 2 days) of each 28-day cycle
- Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
- Participation also includes periodic blood draws and imaging studies
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, and study outline.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed: 9/6/12
Updated: 9/11/12