Clinical studies with mitoxantrone and clodronate showed a better pain reduction in patients with prostate cancer. Both in vitro and animal studies have shown that paclitaxel and biphosphonates act synergistically and prevent formation and…
ID
Bron
Verkorte titel
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary objective of phase II part is to assess the objective PSA response to treatment by serial measurements of serum PSA as defined by the "Bubley".
Primary objectives phase III study is to compare time to progression between concomitant and sequential use of docetaxel and risedronate, in combination with prednison.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
Clinical studies with mitoxantrone and clodronate showed a better pain reduction in patients with prostate cancer. Both in vitro and animal studies have shown that paclitaxel and biphosphonates act synergistically and prevent formation and progression of bone metastasis (breast cancer). This clinical trial studies the effect of risedronate and docetaxel in the treatment of hormone refractory prostate cancer.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Arm A. Docetaxel 75mg/m2 every 3 weeks. Every patient will receive prednison 5 mg bid.
Arm B. Docetaxel 75mg/m2 every 3 weeks plus 30 mg Risedronate once daily. Every patient will receive prednison 5 mg bid.
Treatment will be given until progression, or 10 courses. After progression Risedronate 30 mg od + prednisone 5 mg will be continued.
Publiek
P.O. Box 5201
R. Wit, de
Rotterdam 3008 AE
The Netherlands
r.dewit@erasmusmc.nl
Wetenschappelijk
P.O. Box 5201
R. Wit, de
Rotterdam 3008 AE
The Netherlands
r.dewit@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Histologically proven prostate adenocarcinoma;
2. Hormone refractory;
3. Continued elevated PSA for at least 6 weeks after discontinuation of anti-androgens prior to registration;
4. Last PSA level > 5 ng/ml;
5. Stable analgesic regimen for at least one week prior to registration;
6. Patients without surgical castration must continue on LHRH antogonists;
7. Adequate bone marrow, liver, renal funtion;
8. WHO 0-2.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Previous or concomitant use of biphosphonates;
2. Prior chemotherapy or radiotherapy within 4 weeks prior to treatment start;
3. Uncontrolled hypercalcemia;
4. Brain metastases;
5. Previous or concomitant malignancies;
6. Uncontrolled systemic disease of infection.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL429 |
| NTR-old | NTR469 |
| Ander register | : EMC 03-146 |
| ISRCTN | ISRCTN22844568 |