Status:
COMPLETED
Mitoxantrone, Etoposide, and Vinorelbine As Second-Line Therapy in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
Lead Sponsor:
Groupe D'Etude des Tumeurs Uro-Genitales
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 ...
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 seco...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00627354
Start Date
September 1 2006
Last Update
May 16 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Regional Francois Baclesse
Caen, France, 14076