GEMOX in Docetaxel-Refractory Castration-Resistant Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JLee, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01487720
First received: December 6, 2011
Last updated: November 30, 2013
Last verified: November 2013

December 6, 2011
November 30, 2013
October 2008
October 2013   (final data collection date for primary outcome measure)
PSA response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Based on PCWG 1.0
Same as current
Complete list of historical versions of study NCT01487720 on ClinicalTrials.gov Archive Site
  • PSA decline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Based on PCWG 2.0
  • Time to PSA progression [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Composite progression-free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Based on RECIST, bone scan, and performance status
  • RECIST Response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Based on RECIST v 1.1
  • Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Based on NCI CTCAE v. 4.03
Same as current
Not Provided
Not Provided
 
GEMOX in Docetaxel-Refractory Castration-Resistant Prostate Cancer
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

Prostate cancer is one of the most common malignancies affecting men all over the World. Metastatic prostate cancer responds to androgen deprivation for a variable period (20-25 months). Prostate cancer that grows despite castrate levels of testosterone and that no longer responds to any form of hormonal manipulation is defined as castrate resistant prostate cancer (CRPC).

Docetaxel combined with prednisolone has been shown to not only improve QOL and PSA response in CRPC, but also extend the overall survival1. However, the efficacy of the drug has not been universally effective, and nearly all patients have disease progression after docetaxel treatment.

After failure of a docetaxel regimen, With the exception of cabazitaxel or abiraterone, which are not widely and easily availabe in Korea, little treatment regimen can be applied to the patients with reasonable response and benefits.

Gemcitabine is a nucleoside analog with activity against a broad spectrum of solid tumors. When gemcitabine is used as first-line therapy for CRPC, disease control rate was 33% with median duration of 7.1 months. When it is combined with prednisone and zoledronic acid in pretreated patients with CRPC, the PSA response rate was 23% with a disease control rate of 57% in patients with measurable disease.

Oxaliplatin is newer platinum agent that has favorable toxicity profile and evidence of activity in cisplatin-resistant cell lines. Droz et al. performed a multicenter phase II study in 54 patients with metastatic CRPC who were randomized to receive oxaliplatin either alone or with 5-FU. More than 50% of the patients had received prior chemotherapy including cisplatin. Despite heavy pretreatment, PSA desclines were noted in 11% and 19% of patients in each arm.

Gemcitabine plus oxaliplatin combination was widely studied and has been reported to be safe and effective in various cancers.

This study is to assess the efficacy and safety of GEMOX in docetaxel-refractory CRPC.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: GEMOX
Gemcitabine 1000 mg/m2 IV on day 1 every 2 weeks (fixed-dose rate 10 mg/m2/min) Oxaliplatin 100 mg/m2 IV on day 1 every 2 weeks Prednisolone 5 mg twice a day orally daily
Experimental: GEMOX
GEMOX treatment
Intervention: Drug: GEMOX
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01487720
UOSG-AMC-0802
No
JLee, Asan Medical Center
Asan Medical Center
Not Provided
Not Provided
Asan Medical Center
November 2013

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