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A Prosepctive Phase II Study of Gemcitabine and Oxaliplatin in Combination With Prednisolone for the Treatment of Hormone Refracotry Metastatic Prostate Cancer Previously Treated With Docetaxel Regimen


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

A Prosepctive Phase II Study of Gemcitabine and Oxaliplatin in Combination With Prednisolone for the Treatment of Hormone Refracotry Metastatic Prostate Cancer Previously Treated With Docetaxel Regimen


Inclusion Criteria:



- Histologically or cytologically confirmed adenocarcinoma of the prostate

- Clinical or radiologic evidence of metastatic disease

- Documented disease progression during hormone therapy (ADT plus antiandrogen) and no
response to ADT withdrawal

- Docetaxel-refractory disease defined as disease progression documented either during
treatment of within 60 days after the cessation of treatment with docetaxel

- Prior exposure to estramustine or mitoxantrone is allowed

- KPS ≥ 60

- No prior radioisotope therapy

- No prior radiotherapy 25% or more of the bone marrow

- No peripheral neuropathy grade 2 or worse

- Adequate organ and bone marrow function

Exclusion Criteria:

- Other tumor type than adenocarcinoma

- Presence or history of CNS metastasis

- Other serious illness or medical conditions

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PSA response

Outcome Description:

Based on PCWG 1.0

Outcome Time Frame:

6 months

Safety Issue:

No

Authority:

Korea: Food and Drug Administration

Study ID:

UOSG-AMC-0802

NCT ID:

NCT01487720

Start Date:

October 2008

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Castration-resistant prostate cancer
  • Docetaxel-refractory status
  • Prostatic Neoplasms

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