Satraplatin in Hormone Refractory Prostate Cancer Patients Previously Treated With One Cytotoxic Chemotherapy Regimen
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer Hormone Refractory Prostate Cancer |
Drug: Satraplatin Drug: Prednisone |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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No publications provided
| Responsible Party: | Agennix |
| ClinicalTrials.gov Identifier: | NCT00069745 History of Changes |
| Other Study ID Numbers: | GPC SAT3-03-01 |
| Study First Received: | September 30, 2003 |
| Last Updated: | August 1, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Agennix:
|
Prostatic Neoplasms Cancer Treatment Protocols Antineoplastic protocols One Prior Cytotoxic Chemotherapy Regimen |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Prednisone Satraplatin |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 21, 2013