GEMOX in Docetaxel-Refractory Castration-Resistant Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GEMOX
Sponsored by

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Castration-resistant prostate cancer, Docetaxel-refractory status
Eligibility Criteria
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
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GEMOX
Arm Description
GEMOX treatment
Outcomes
Primary Outcome Measures
PSA response
Based on PCWG 1.0
Secondary Outcome Measures
PSA decline
Based on PCWG 2.0
Time to PSA progression
Composite progression-free survival
Based on RECIST, bone scan, and performance status
RECIST Response
Based on RECIST v 1.1
Safety
Based on NCI CTCAE v. 4.03
Full Information
NCT ID
NCT01487720
First Posted
December 6, 2011
Last Updated
November 30, 2013
Sponsor
Asan Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01487720
Brief Title
GEMOX in Docetaxel-Refractory Castration-Resistant Prostate Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Castration-resistant prostate cancer, Docetaxel-refractory status
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GEMOX
Arm Type
Experimental
Arm Description
GEMOX treatment
Intervention Type
Drug
Intervention Name(s)
GEMOX
Intervention Description
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
Primary Outcome Measure Information:
Title
PSA response
Description
Based on PCWG 1.0
Time Frame
6 months
Secondary Outcome Measure Information:
Title
PSA decline
Description
Based on PCWG 2.0
Time Frame
6 months
Title
Time to PSA progression
Time Frame
12 months
Title
Composite progression-free survival
Description
Based on RECIST, bone scan, and performance status
Time Frame
12 months
Title
RECIST Response
Description
Based on RECIST v 1.1
Time Frame
6 months
Title
Safety
Description
Based on NCI CTCAE v. 4.03
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
GEMOX in Docetaxel-Refractory Castration-Resistant Prostate Cancer
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