Satraplatin and Prednisone to Treat Prostate Cancer

NCT00634647 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 08007408-C-0074
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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-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. Objectives: To determine if satraplatin may help treat prostate cancer in patients with certain variants of the ERCC1 gene. Eligibility: 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. Design: 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:

• Blood tests on days 1 of the treatment cycle.
• Weekly blood draws for the first 3 treatment cycles.
• Imaging studies (e.g., bone scans, computed tomography (CT) scans) every two cycles to determine the response to treatment.
• Surgical or medical suppression of testosterone in patients whose cancer cells continue to grow due to exposure to the hormone....

Conditions

Prostate Cancer; Genetic Polymorphism

Keywords

Chemotherapy; Pharmacokinetics; Gene Polymorphisms; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival.

  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.

  15 months

Secondary Outcomes (2)

• Number of Participants With Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0)

  Date treatment consent signed to date off study, approximately 57 months.

• Median Overall Survival (OS)

  time between the first day of treatment to the day of death, approximately 15.7 months

Study Arms (1)

Satraplatin

EXPERIMENTAL

satraplatin - 80 mg/m\^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days

Drug: Satraplatin; Drug: prednisone

Interventions

Satraplatin DRUG

80 mg/m\^2 days 1-5 of every 35 day cycle

Satraplatin

prednisone DRUG

5 mg twice daily every 35 days

Satraplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Associates in Oncology and Hematology

Rockville, Maryland, 20850, United States

Location

Related Publications (3)

• Moul JW. Prostate specific antigen only progression of prostate cancer. J Urol. 2000 Jun;163(6):1632-42.

  PMID: 10799151 BACKGROUND

• Zelefsky MJ, Ben-Porat L, Scher HI, Chan HM, Fearn PA, Fuks ZY, Leibel SA, Venkatraman ES. Outcome predictors for the increasing PSA state after definitive external-beam radiotherapy for prostate cancer. J Clin Oncol. 2005 Feb 1;23(4):826-31. doi: 10.1200/JCO.2005.02.111.

  PMID: 15681527 BACKGROUND

• Catalona WJ, Smith DS. Cancer recurrence and survival rates after anatomic radical retropubic prostatectomy for prostate cancer: intermediate-term results. J Urol. 1998 Dec;160(6 Pt 2):2428-34. doi: 10.1097/00005392-199812020-00012.

  PMID: 9817397 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

satraplatin; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. William Dahut
• Organization: National Cancer Institute, National Institutes of Health

dahutw@mail.nih.gov

301-435-8183

Study Officials

• William L Dahut, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 12, 2008
• First Posted: March 13, 2008
• Study Start: February 19, 2008
• Primary Completion: February 1, 2011
• Study Completion: May 1, 2012
• Last Updated: October 2, 2018
• Results First Posted: April 10, 2013

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)