Satraplatin and Prednisone to Treat Prostate Cancer
|First Received Date ICMJE||March 12, 2008|
|Last Updated Date||April 15, 2013|
|Start Date ICMJE||February 2008|
|Primary Completion Date||August 2011 (final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Progression Free Survival. [ Time Frame: 15 months ] [ Designated as safety issue: No ]
Time between the start of therapy and progression. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progressive Disease is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
|Original Primary Outcome Measures ICMJE
||Progression-free survival [ Designated as safety issue: No ]|
|Change History||Complete list of historical versions of study NCT00634647 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Toxicity [ Time Frame: 6/4/08/ to 4/1/12 ] [ Designated as safety issue: Yes ]
Here is the number of participants with adverse events. For a detailed of list of adverse events, see the adverse event module.
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Satraplatin and Prednisone to Treat Prostate Cancer|
|Official Title ICMJE||A Phase II Study of Satraplatin and Prednisone in Metastatic Androgen Independent Prostate Cancer (AIPC)|
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-complementing rodent repair deficiency complementation group 1 (ERCC1) helps repair cell damage caused by satraplatin. It is possible that patients who have a variant of this gene will not benefit from treatment with satraplatin because the drug will not be able to damage the cancer cells effectively.
To determine if satraplatin may help treat prostate cancer in patients with certain variants of the ERCC1 gene.
Patients with advanced androgen-independent prostate cancer whose disease has not responded to hormonal therapy or at least one type of chemotherapy and whose x-rays, scans or other tests have shown their cancer to be spreading.
Participants have a blood test to determine if they have a variant of the ERCC1 gene.
Participants take satraplatin by mouth every day for 5 consecutive days out of every 35 days and prednisone by mouth every day. These 35-day treatment cycles may continue for 6 months or longer, depending on the benefits and side effects of the treatment.
During the treatment period, patients undergo the following tests and procedures:
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Study Arm (s)||Experimental: Satraplatin
satraplatin - 80 mg/m^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Completion Date||July 2013|
|Primary Completion Date||August 2011 (final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
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.
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.
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.
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00634647|
|Other Study ID Numbers ICMJE||080074, 08-C-0074|
|Has Data Monitoring Committee||Yes|
|Responsible Party||William Dahut Jr., M.D., National Institutes of Health Clinical Center (CC)|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||April 2013|
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