Back to resultsMitoxantrone, Etoposide, and Vinorelbine As Second-Line Therapy in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
etoposide
mitoxantrone hydrochloride
prednisone
vinorelbine tartrate
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring stage IV prostate cancer, recurrent prostate cancer, adenocarcinoma of the prostate
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Metastatic progressive disease meeting the following criteria:
- Increase in measurable lesions > 25%
- Increase in bone lesions > 25%
- Biological progression rate of PSA > 4 ng/mL
- Received docetaxel as first-line chemotherapy
- Received at least 1 prior regimen of hormone therapy
- Pain > 2 on Visual Analog Scale or continuing level 2 analgesics
- No symptomatic or evolutionary CNS disease
PATIENT CHARACTERISTICS:
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 1.5 times normal
- Alkaline phosphatase ≤ 2 times normal (unless bone metastases are present)
- Transaminases ≤ 1.5 times normal
- Bilirubin ≤ 1.5 times normal
- No prior malignancy except basal cell skin cancer
- No peripheral neuropathy or severe neuropathy ≥ grade 2
- No other severe lung, hepatic, renal, or digestive disease that would be complicated by treatment
- LVEF > 50%
- No history of peptic ulcer, unstable diabetes, or other contraindication to using steroids
- No severe infection requiring antibiotics
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 8 weeks since prior metabolic radiotherapy
- More than 4 weeks since prior external radiotherapy
- At least 1 month since prior docetaxel-based chemotherapy
- At least 1 month since prior antiandrogen therapy in the case of complete hormonal blockage
- No participation in another clinical trial within the past 30 days
Sites / Locations
- Centre Regional Francois Baclesse
Outcomes
Primary Outcome Measures
Palliative response rate
Secondary Outcome Measures
Duration of palliative response
Biological response
Tumor response as assessed by RECIST criteria
Time to progression
Overall survival
Quality of life as assessed by QLQ-PR25
Impact on autonomy in patients > 70 years of age
Toxicity
Full Information
NCT ID
NCT00627354
First Posted
February 29, 2008
Last Updated
May 13, 2011
Sponsor
Groupe D'Etude des Tumeurs Uro-Genitales
1. Study Identification
Unique Protocol Identification Number
NCT00627354
Brief Title
Mitoxantrone, Etoposide, and Vinorelbine As Second-Line Therapy in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
Official Title
Phase 2 Randomized Study Evaluating 3 Chemotherapy Regimens as Second-line Treatment in Patients With Hormone-refractory Metastatic Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Groupe D'Etude des Tumeurs Uro-Genitales
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as mitoxantrone, etoposide, and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which drug is more effective in killing tumor cells.
PURPOSE: This randomized phase II trial is studying how well mitoxantrone works compared to etoposide or vinorelbine works as second-line therapy in treating patients with metastatic prostate cancer that did not respond to hormone therapy.
Detailed Description
OBJECTIVES:
Primary
Determine the palliative response rate in patients with hormone-resistant prostate cancer treated with mitoxantrone hydrochloride vs etoposide vs vinorelbine ditartrate as second-line therapy.
Secondary
Determine the duration of palliative response in patients treated with these regimens.
Determine the biological response (PSA > 50%) in these patients.
Determine the time to progression (biological and clinical) in these patients.
Determine the overall survival of these patients.
Determine the quality of life and the impact on autonomy of patients over 70 years of age.
Determine the toxicity of these regimens in these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 3 treatment arms.
Arm I: Patients receive mitoxantrone hydrochloride IV over 5 minutes once a week for 3 weeks.
Arm II: Patients receive oral etoposide twice daily on days 1-14.
Arm III: Patients receive oral vinorelbine ditartrate once daily on days 1 and 8 and oral prednisone once daily on days 1-21.
Treatment in all three arms repeats every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage IV prostate cancer, recurrent prostate cancer, adenocarcinoma of the prostate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
mitoxantrone hydrochloride
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Type
Drug
Intervention Name(s)
vinorelbine tartrate
Primary Outcome Measure Information:
Title
Palliative response rate
Secondary Outcome Measure Information:
Title
Duration of palliative response
Title
Biological response
Title
Tumor response as assessed by RECIST criteria
Title
Time to progression
Title
Overall survival
Title
Quality of life as assessed by QLQ-PR25
Title
Impact on autonomy in patients > 70 years of age
Title
Toxicity
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Metastatic progressive disease meeting the following criteria:
Increase in measurable lesions > 25%
Increase in bone lesions > 25%
Biological progression rate of PSA > 4 ng/mL
Received docetaxel as first-line chemotherapy
Received at least 1 prior regimen of hormone therapy
Pain > 2 on Visual Analog Scale or continuing level 2 analgesics
No symptomatic or evolutionary CNS disease
PATIENT CHARACTERISTICS:
ANC ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Creatinine ≤ 1.5 times normal
Alkaline phosphatase ≤ 2 times normal (unless bone metastases are present)
Transaminases ≤ 1.5 times normal
Bilirubin ≤ 1.5 times normal
No prior malignancy except basal cell skin cancer
No peripheral neuropathy or severe neuropathy ≥ grade 2
No other severe lung, hepatic, renal, or digestive disease that would be complicated by treatment
LVEF > 50%
No history of peptic ulcer, unstable diabetes, or other contraindication to using steroids
No severe infection requiring antibiotics
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
More than 8 weeks since prior metabolic radiotherapy
More than 4 weeks since prior external radiotherapy
At least 1 month since prior docetaxel-based chemotherapy
At least 1 month since prior antiandrogen therapy in the case of complete hormonal blockage
No participation in another clinical trial within the past 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florence Joly, MD, PhD
Organizational Affiliation
Centre Francois Baclesse
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Regional Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
12. IPD Sharing Statement
Learn more about this trial
Mitoxantrone, Etoposide, and Vinorelbine As Second-Line Therapy in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
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