GEMOX in Docetaxel-Refractory Castration-Resistant Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01487720
• Other study ID #: UOSG-AMC-0802
• Status: Completed
• Phase: Phase 2
• First received: December 6, 2011
• Last updated: November 30, 2013
• Start date: October 2008
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA response	Based on PCWG 1.0	6 months	No
Secondary	PSA decline	Based on PCWG 2.0	6 months	No
Secondary	Time to PSA progression		12 months	No
Secondary	Composite progression-free survival	Based on RECIST, bone scan, and performance status	12 months	No
Secondary	RECIST Response	Based on RECIST v 1.1	6 months	No
Secondary	Safety	Based on NCI CTCAE v. 4.03	6 months	Yes