Status:
COMPLETED
Docetaxel and Prednisone in Treating Patients With Hormone-Refractory Metastatic Prostate Cancer
Lead Sponsor:
Tampere University
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving...
Detailed Description
OBJECTIVES: Primary * Compare the time to treatment failure in patients with hormone-refractory metastatic prostate cancer treated with two different schedules of docetaxel in combination with predn...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Metastatic disease by imaging or clinical examination
- Hormone-refractory disease, defined as prostate-specific antigen (PSA) level \> 10 µg/L AND rising between 2 sequential measurements
- Testosterone within castration levels by orchiectomy or medical castration comprising luteinizing hormone-releasing hormone (LHRH) analogues
- PATIENT CHARACTERISTICS:
- Age
- Over 18
- Performance status
- WHO 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Neutrophil count ≥ 1,500/mm\^3
- Hemoglobin ≥ 11.0 g/dL
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- ALT and AST ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin normal
- Alkaline phosphatase ≤ 6 times ULN (unless due to the presence of extensive bone disease)
- No serious liver disease
- Renal
- Creatinine ≤ 1.5 times ULN
- Cardiovascular
- No ischemic or thromboembolic cardiac disease
- No myocardial infarction within the past 12 months
- No other serious cardiac disease
- Pulmonary
- No pulmonary emboli
- Immunologic
- No active infection
- No autoimmune disease, including any of the following:
- Lupus
- Scleroderma
- Rheumatoid polyarthritis
- Other
- No active peptic ulcer
- No unstable diabetes mellitus
- No contraindication to corticosteroids
- No other malignant disease within the past 5 years except basalioma
- No functional iron deficiency (i.e., transferrin saturation \< 20%) that cannot be treated with iron supplementation
- No other serious illness or medical condition
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- More than 2 months since prior recombinant human epoetin alfa or any other erythropoiesis-stimulating drug
- Chemotherapy
- At least 3 weeks since prior estramustine
- Endocrine therapy
- See Disease Characteristics
- At least 3 weeks since prior antiandrogen treatment
- Concurrent chemical castration with LHRH allowed provided patient has begun treatment prior to study entry
- No initiation of chemical castration therapy during study treatment
- Radiotherapy
- No prior radiotherapy to \> 25% of bone marrow
- No prior radioisotope therapy
- Concurrent local palliative radiotherapy for pain allowed
- Surgery
- See Disease Characteristics
- At least 4 weeks since prior surgery
- Other
- No other prior cytostatic treatment
- Concurrent bisphosphonates allowed provided patient has begun treatment prior to study entry
- No initiation of bisphosphonates during study treatment
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2010
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00255606
Start Date
August 1 2005
End Date
August 1 2010
Last Update
June 26 2013
Active Locations (19)
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1
Helsinki University Central Hospital
Helsinki, Finland, FIN-00029
2
Kainuu Central Hospital
Kajaani, Finland, 87140
3
Keski-Pohjanmaa Central Hospital
Kokkola, Finland, 67200
4
Kymenlaakso Central Hospital
Kotka, Finland, 48210