Status:
COMPLETED
Satraplatin and Prednisone to Treat Prostate Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Genetic Polymorphism
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
Background: Satraplatin is an experimental drug that may be of benefit to patients with prostate cancer. Prednisone is approved for treating prostate cancer. The gene excision repair cross-compleme...
Detailed Description
Background: * Satraplatin is an oral, third-generation platinum analog that has recently been shown to increase prostatic specific antigen (PSA) decline rates and progression-free survival in hormone...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- A. Patients must have histopathological confirmation of prostate cancer by the Laboratory of Pathology of the National Cancer Institute (NCI) or Pathology Department of the National Naval Medical Center or Walter Reed Army Medical Center prior to entering this study. Patients whose pathology specimens are not available may be enrolled in the trial if the patient has a clinical course consistent with prostate cancer and available documentation from an outside pathology laboratory of the diagnosis. In cases where original tissue blocks or archival biopsy material is available, all efforts should be made to have the material forwarded to the research team for use in correlative studies.
- B. Patients must have metastatic progressive androgen-independent prostate cancer. There must be radiographic evidence of disease (by computed tomography (CT) scan or bone scan) after primary treatment that has continued to progress despite hormonal agents. Progression requires that a measurable lesion is expanding, new lesions have appeared, and/or that prostatic specific antigen (PSA) is continuing to rise on successive measurements. Patients must have progressive disease after receiving 1 prior docetaxel-based cytotoxic chemotherapy. Patients on flutamide for the prior 6 months must have disease progression at least 4 weeks after withdrawal. Patients on bicalutamide or nilutamide must have progression at least 6 weeks after withdrawal.
- C. Patients may only have received 1 prior cytotoxic chemotherapy. For the purpose of this study, multiple courses of a taxane-based regimen may count as a single regimen. Multiple courses of a non-taxane agent or a combination chemotherapy regimen, administered in a similar fashion may count as a single regimen.
- D. Patients must have a life expectancy of more than 3 months.
- E. Patients must have a performance status of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG) criteria.
- F. Patients must have adequate organ function as defined below:
- Leukocytes greater than or equal to 3,000/microl.
- Absolute Neutrophil Count greater than or equal to 1,500/microl.
- Platelets greater than or equal to 100,000/microl.
- Total bilirubin less than or equal to 1.5 times institutional upper limits of normal (Except patients with Gilbert's disease who may proceed despite elevated total bilirubin).
- Aspartate aminotransferase (AST)serum glutamic oxaloacetic transaminase(SGOT) and alanine aminotransferase (ALT)serum glutamic pyruvic transaminase (SGPT) less than or equal to 2.5 times institutional upper limit of normal
- Creatinine less than or equal to 1.5 times institutional upper limits of normal.
- OR
- Creatinine clearance greater than or equal to 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal.
- G. Patients must have recovered from any acute toxicity related to prior therapy, including surgery. Toxicity should be \<= grade 1 or returned to baseline.
- H. Hormonal profile: all patients who have not undergone bilateral surgical castration must continue suppression of testosterone production by appropriate usage of gonadotropin releasing hormone (GnRH) agonists.
- I. Patients must not have any ongoing malignancies requiring active therapy.
- J. Patients must be able to understand and sign an informed consent form.
- K. Concurrent use of bisphosphonates will be allowed if patients have previously been on it; if patients are not on bisphosphonates at the time of study enrollment, bisphosphonates may be started at cycle 2.
- L. Patients who require hematopoietic growth factor support (e.g. epogen, darbepoetin), but not myeloid growth factors (except after cycle 1 day 1 if clinically indicated), non-steroidal anti-inflammatory drug (NSAIDs), and other maintenance medications prior to study entry will be allowed to continue their supportive therapies.
- M. Results from embryo-fetal development indicated that satraplatin should be considered a teratogen in women of childbearing potential and hazardous in respect to spermatogenesis for men. For this reason, men must agree to use adequate contraception (abstinence; hormonal or barrier method of birth control) prior to study entry and for the duration of study participation.
- N. Patients must be able to swallow capsules.
- O. Patients on chronic stable steroids (equivalent to no more than 10 mg of prednisone daily dose) used for non-cancer treatment may be allowed on study.
- EXCLUSION CRITERIA:
- A. Patients who have had prior treatment with satraplatin or other platinum containing compounds will be excluded.
- B. Patients may not be receiving any other investigational agents.
- C. Patients with known active brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- D. History of allergic reactions attributed to compounds of similar chemical or biologic composition to satraplatin or prednisone.
- E. Uncontrolled intercurrent illness including, but not limited to ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit patient compliance with study requirements.
- F. Prior radiation therapy to greater than 30 percent of the bone marrow, or who have received strontium-89, rhenium-186, or rhenium-188 will be excluded from this trial. Patients who have received prior radiotherapy must have recovered from acute toxicity due to radiation. Patients who have received samarium-153 are eligible for the study because samarium has a significantly reduced half-life compared to aforementioned isotopes.
- G. Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, human immunodeficiency virus (HIV)-positive patients are excluded from the study.
- H. Patients with a history of major gastrointestinal surgery or pathology likely to influence absorption of oral medications, like bypass surgeries, Whipple's procedure, or any surgery that would impair reliable absorption of oral drugs.
- I. Patients with a disease where corticosteroids are contraindicated, e.g. active gastric or duodenal ulcer, or poorly controlled insulin dependent diabetes. Patients with well-controlled insulin-dependent diabetes mellitus may be considered, providing they understand their glucose levels will increase, and their insulin dose will require adjusting.
- J. Because no dosing or adverse event data are currently available on the use of satraplatin in patients less than 18 years of age, children are excluded from this study.
Exclusion
Key Trial Info
Start Date :
February 19 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00634647
Start Date
February 19 2008
End Date
May 1 2012
Last Update
October 2 2018
Active Locations (2)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
2
Associates in Oncology and Hematology
Rockville, Maryland, United States, 20850