Trial | NCT00069745  Report issue

Title

Satraplatin in Hormone Refractory Prostate Cancer Patients Previously Treated With One Cytotoxic Chemotherapy Regimen
A Multi-National Phase III Study of Satraplatin Plus Prednisone or Placebo Plus Prednisone in Patients With Hormone Refractory Prostate Cancer Previously Treated With One Cytotoxic Chemotherapy Regimen

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Indication/Condition

    Prostate Cancer ...

  • Study Participants

    None
PURPOSE:

The SPARC trial is designed to compare the combination of the investigational oral cytotoxic drug, satraplatin, and prednisone, versus prednisone alone as second line chemotherapy in patients with hormone-refractory prostate cancer (HRPC).

TARGET PATIENT POPULATION:

The SPARC trial is intended for patients who have hormone-refractory prostate cancer (HRPC) and whose disease has progressed after treatment with one chemotherapy regimen. Please refer to the Eligibility Criteria page for the key inclusion and exclusion criteria.

WHAT IS SATRAPLATIN:

Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally. Satraplatin is also the only platinum-based drug that has demonstrated efficacy against prostate cancer in a randomized trial.

RATIONALE:

There are currently no approved chemotherapy drugs for the second line treatment of hormone-refractory prostate cancer (HRPC). In a preliminary randomized trial conducted in Europe, the combination of satraplatin and prednisone had superior activity compared to prednisone alone, for the treatment of HRPC patients who had not previously been treated with chemotherapy
Study Started
Sep 30
2003
Primary Completion
Jan 31
2006
Study Completion
Mar 31
2007
Last Update
Aug 07
2012
Estimate

Drug Satraplatin

Drug Prednisone

Criteria 

Inclusion Criteria:

Stage D2 metastatic prostate cancer
Progression after one prior chemotherapy
ECOG Performance status equal / less than 2
Life expectancy > 3 months
Surgical or medical castration
Adequate bone marrow, hepatic and renal functions
Informed consent

Exclusion Criteria:

More than one prior chemotherapy
Prior platinum containing compounds
Prior malignancy
Prior significant RT/radionuclide therapy
Major GI surgery or GI disease affecting absorption
Disease with contraindication to steroids
Brain metastases
No Results Posted