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A Phase I Trial of Satraplatin Plus Radiation Therapy for Prostate Cancer Patients With Biochemical Recurrence

This study has been terminated.
(Sponsor decided to discontinue study drug development)
Sponsor:
Information provided by (Responsible Party):
Agennix
ClinicalTrials.gov Identifier:
NCT00480623
First received: May 29, 2007
Last updated: March 21, 2012
Last verified: March 2012

May 29, 2007
March 21, 2012
May 2007
March 2008   (final data collection date for primary outcome measure)
Determine maximum tolerated dose and dose limiting toxicity for the combination of Satraplatin and radiation therapy. [ Time Frame: Serum chemistry and CBC will be evaluated weekly. PSA level will be evaluated on Day on of week 5. ]
Same as current
Complete list of historical versions of study NCT00480623 on ClinicalTrials.gov Archive Site
PSA Response, Time to PSA Response, Duration of PSA response, Secondary Biochemical Recurrence Free Survival, Time to Biochemical Recurrence, Effect of Satraplatin on Serum Testosterone Levels, Safety and Tolerability. [ Time Frame: PSA level will be evaluated on Day on of week 5. There will be an end of treatment visit within 30 days of the last RT-Satraplatin treatment. PSA will be drawn every 3 m for 2 years, then every 6 m until evidence of either PSA or clinical progression. ]
Same as current
Not Provided
Not Provided
 
A Phase I Trial of Satraplatin Plus Radiation Therapy for Prostate Cancer Patients With Biochemical Recurrence
A Phase I Trial of Satraplatin Plus Radiation Therapy for Prostate Cancer Patients With Biochemical Recurrence Following Radical Prostatectomy

This study is designed to measure the impact of Satraplatin plus radiation therapy to the bed of the prostate in patients who have developed biochemical failure of their prostate cancer. The main objective of this study is to determine the maximum tolerated dose and dose limiting toxicity for the combination of satraplatin and radiation therapy and to determine the recommended dose for subsequent Phase II trials.

****Please Note: Dr.Howard Sandler's site will be open to accrual shortly, Dr. Sarantopoulos's site in San Antonio is open and recruiting patients.****

There were approximately 232,000 cases of prostate cancer diagnosed in the US in 2005. Most patients present with localized disease and undergo curative therapy, either radical prostatectomy (RP) or radiation therapy (RT). Although most men are cured after this therapy, approximately 30,000-50,000 annually in the US will develop recurrence after RP. For most of these patients, recurrence will be defined by biochemical recurrence (BCR), a rise in PSA with no other documented evidence of recurrence. Patients with BCR typically receive radiation therapy to the prostate bed. However, about 50% of these patients will develop distant recurrence outside of the pelvis and require systemic therapy.

Satraplatin is a third generation orally administered platinum compound. Early clinical studies demonstrated activity in tumors of the ovary and lung in addition to prostate cancer. Satraplatin has shown activity in prostate cancer in Phase II studies and has been evaluated in a pivotal Phase III study (The SPARC trial)as a single agent as second line therapy.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: Satraplatin plus radiation therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
Not Provided
April 2008
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Over or equal to 18 years of age.
  • ECOG performance status less than or equal to 1
  • Adequate organ function.
  • History of radical prostatectomy with histopathologic documentation of adenocarcinoma of the prostate.
  • PSA over or equal to 0.2 ng/ml or less than or equal to 0.4 ng/ml. This includes patients whose PSA never becomes detectable. PSA progression must be measured by two consecutive samples, each separated by over or equal to 7 days. The PSA values of the two consecutive sample values must be greater than the previous (baseline) value, not greater than each other.

Exclusion Criteria:

  • Known sites of measurable prostate cancer or bone scan positive for metastatic prostate cancer. (patients with a positive Prostascint scan will not be excluded)
  • Prior therapy for prostate cancer except RP and neoadjuvant hormonal therapy. This includes chemo, hormonal (except neoadjuvant), RT, and biologic therapy.
  • Lack of physical integrity of the upper GI tract, malabsorption syndromes, or inability to tolerate or absorb oral medications, including Crohn's disease and ulcerative colitis.
  • Other concurrent immunotherapy, RT, chemotherapy,or ancillary therapy considered investigational (utilized for non-FDA approved indications and the context of a research investigation)and any chemotherapy not included in the study protocol.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00480623
SAT1-06-01
No
Agennix
Agennix
Not Provided
Principal Investigator: Howard Sandler, MD University of Michigan
Agennix
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP