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GEMOX in Docetaxel-Refractory Castration-Resistant Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01487720
Recruitment Status : Completed
First Posted : December 7, 2011
Last Update Posted : December 3, 2013
Sponsor:
Information provided by (Responsible Party):
JLee, Asan Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: GEMOX Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2008
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Docetaxel
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: GEMOX
GEMOX treatment
 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


Outcome Measures
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Primary Outcome Measures :
  1. PSA response [ Time Frame: 6 months ]
    Based on PCWG 1.0


Secondary Outcome Measures :
  1. PSA decline [ Time Frame: 6 months ]
    Based on PCWG 2.0

  2. Time to PSA progression [ Time Frame: 12 months ]
  3. Composite progression-free survival [ Time Frame: 12 months ]
    Based on RECIST, bone scan, and performance status

  4. RECIST Response [ Time Frame: 6 months ]
    Based on RECIST v 1.1

  5. Safety [ Time Frame: 6 months ]
    Based on NCI CTCAE v. 4.03


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01487720


Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: JLee, Associate Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01487720     History of Changes
Other Study ID Numbers: UOSG-AMC-0802
First Posted: December 7, 2011    Key Record Dates
Last Update Posted: December 3, 2013
Last Verified: November 2013

Keywords provided by JLee, Asan Medical Center:
Castration-resistant prostate cancer
Docetaxel-refractory status

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Oxaliplatin
Prednisolone
Antineoplastic Agents
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal