Satraplatin in Hormone Refractory Prostate Cancer Patients Previously Treated With One Cytotoxic Chemotherapy Regimen - Full Text View

Sponsor:	GPC Biotech
Information provided by:	GPC Biotech
ClinicalTrials.gov Identifier:	NCT00069745

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 One Prior Cytotoxic Chemotherapy Regimen	Drug: Satraplatin Drug: Prednisone	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Prednisone JM 216

U.S. FDA Resources

Further study details as provided by GPC Biotech:

Study Start Date:	September 2003
Estimated Study Completion Date:	March 2007

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069745

Show 212 Study Locations

Sponsors and Collaborators

GPC Biotech

More Information

No publications provided

Study ID Numbers:	GPC SAT3-03-01
Study First Received:	September 30, 2003
Last Updated:	September 10, 2007
ClinicalTrials.gov Identifier:	NCT00069745 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GPC Biotech:

Prostatic Neoplasms
Cancer Treatment Protocols
Antineoplastic protocols

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 11, 2009