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Satraplatin and Prednisone in Treating Patients With Progressive, Metastatic Prostate Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), June 2009
First Received: March 12, 2008   Last Updated: September 23, 2009   History of Changes
Sponsor: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00634647
  Purpose

RATIONALE: Drugs used in chemotherapy, such as satraplatin and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving satraplatin together with prednisone may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving satraplatin together with prednisone works in treating patients with progressive, metastatic prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: prednisone
Drug: satraplatin
Genetic: gene expression analysis
Genetic: polymerase chain reaction
Genetic: polymorphism analysis
Other: pharmacological study
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled
Official Title: A Phase II Study of Satraplatin and Prednisone in Metastatic Androgen Independent Prostate Cancer (AIPC)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Genotyping [ Designated as safety issue: No ]
  • Prostate-specific antigen [ Designated as safety issue: No ]
  • Molecular endpoints [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: September 2007
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To determine if the presence of ERCC1 variant gene polymorphism may be associated with an impact on the progression-free survival of patients with metastatic androgen-independent prostate cancer.

Secondary

  • To measure the overall response rate and overall survival in a post-hoc analysis.
  • To demonstrate the biologic effect of satraplatin in white blood cell collections and in the tumor whenever possible.
  • To determine the correlation of biologic or clinical effects with prostate-specific antigen (PSA) progression.
  • To determine the incidence of different gene polymorphisms by genotyping using polymerase-chain reaction (PCR) followed by either restriction fragment length polymorphism or direct sequencing to genotype single nucleotide polymorphisms of ERCC1, XRCC1, and PARP1.
  • To evaluate the correlation between genotype expression, repair pathways, and clinical events.

OUTLINE: Patients receive oral satraplatin once daily on days 1-5 and oral prednisone twice daily on days 1-35. Courses repeat every 35 days in the absence of disease progression or unacceptable toxicity.

Blood samples are collected periodically and analyzed for genotyping and circulating tumor cells of ERCC1 and other gene polymorphisms via polymerase chain reaction (PCR).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate cancer, meeting the following criteria:

    • Metastatically progressive disease
    • Androgen-independent disease
  • Patients whose pathology specimens are not available may be enrolled in the trial provided the patient has a clinical course consistent with prostate cancer and available documentation from an outside pathology laboratory of the diagnosis
  • Must have radiographic evidence of disease by CT scan or bone scan that has continued to progress after primary treatment despite hormonal agents

    • Progression requires that a measurable lesion is expanding, new lesions have appeared, and/or the prostate-specific antigen (PSA) is continuing to rise on successive measurements

      • 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
  • Must have progressive disease after 1 prior cytotoxic chemotherapy but may have had no more than 1 previous cytotoxic chemotherapeutic line

    • 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 may count as a single regimen
  • Patients who have not undergone bilateral surgical castration must continue suppression of testosterone production by appropriate usage of GnRH agonists
  • No known active brain metastases

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • Leukocytes ≥ 3,000/μL
  • Absolute neutrophil count ≥ 1,500/μL
  • Platelets ≥ 100,000/μL
  • Total bilirubin ≤ 1.5 times upper limits of normal (ULN) (except for patients with Gilbert disease)
  • AST and ALT ≤ 2.5 times ULN
  • Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
  • No ongoing malignancies requiring active therapy
  • Fertile patients must use effective contraception
  • Must be able to swallow capsules
  • Able to understand and sign an informed consent

Exclusion criteria:

  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to satraplatin or prednisone
  • Uncontrolled intercurrent illness including, but not limited to, any of the following:

    • Ongoing or active serious infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Psychiatric illness/social situations that would limit patient compliance with study requirements
  • HIV positivity
  • Diseases where corticosteroids are contraindicated, (e.g. , active gastric or duodenal ulcer, or poorly-controlled insulin dependent diabetes)

    • Well-controlled insulin-dependent diabetes mellitus allowed provided the patient understands that their glucose levels will increase which will require their insulin dose to be adjusted

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

  • See Disease Characteristics
  • Recovered from all prior therapy
  • Concurrent bisphosphonates allowed provided the patient has been previously receiving that drug

    • If patients are not currently receiving bisphosphonates at the time of study enrollment, bisphosphonates may be started in course 2
  • Patients who require hematopoietic growth factor support (e.g., epoetin alfa or darbepoetin), but not myeloid growth factors (i.e., filgrastim [G-CSF], sargramostim [GM-CSF], or other bone marrow stimulants) (except after course 1 if clinically indicated), NSAIDs, and other maintenance medications prior to study entry are allowed to continue their supportive therapies
  • Patients on chronic stable steroids (e.g., no more than 10 mg prednisone/day) for a non-cancerous condition allowed
  • Prior samarium-153 allowed

Exclusion criteria:

  • Prior satraplatin or other platinum-containing compounds
  • Prior radiotherapy to > 30% of the bone marrow
  • Prior strontium chloride Sr 89, rhenium Re186, or rhenium Re188
  • Prior major gastrointestinal surgery or pathology likely to influence absorption of oral medications (i.e., bypass surgeries, Whipple's procedure, or any surgery that would impair reliable absorption of oral drugs)
  • Concurrent prophylactic growth factor support
  • Concurrent anticancer treatment with chemotherapy, radiotherapy, major surgical procedures for prostate cancer, or nonprotocol-related immunotherapy
  • Other concurrent investigational or commercial agents or therapies other than those used for this study with the intent to treat the patient's malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00634647

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center     888-NCI-1937        
Sponsors and Collaborators
Investigators
Principal Investigator: William Dahut, MD National Cancer Institute (NCI)
  More Information

Additional Information:
No publications provided

Responsible Party: NCI - Center for Cancer Research ( William Dahut )
Study ID Numbers: CDR0000589015, NCI-08-C-0074, NCI-P07140
Study First Received: March 12, 2008
Last Updated: September 23, 2009
ClinicalTrials.gov Identifier: NCT00634647     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Prednisone
Satraplatin
Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
Glucocorticoids
Hormones
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 05, 2009